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Location: On-Site in Boulder, CO (Foresight Dx business unit, a Natera company)

Foresight Diagnostics is a molecular diagnostics company pioneering non-invasive cancer detection through highly sensitive, cell-free DNA-based liquid biopsy technologies. Our proprietary methods - originally developed at Stanford University - are designed to detect smaller tumors earlier and enable more personalized treatment strategies for patients with cancer.

We sit at the intersection of molecular biology, bioinformatics, and next-generation sequencing (NGS), and we translate rigorous science into clinically meaningful solutions. Following our acquisition by Natera, we now combine the agility of a mission-driven startup with the scale and resources of a global leader in cell-free DNA testing. It’s an exciting moment to join us.

Headquartered in Boulder, Colorado, our team operates in a high accountability, collaborative environment where quality and continuous improvement aren’t just values - they’re how we work every day.

About The Role

The Clinical Lab Supervisor is a leader in Natera’s lab operations whose role is to oversee employees’ performance and serve as a liaison between employees and senior management to meet company goals and quality objectives. The supervisor is responsible for daily supervision of lab staff performing duties such as laboratory testing and data review. Duties include but are not limited to coaching, motivating, staffing, evaluating, and training staff. The supervisor works closely with the manager to ensure company and team goals are met while adhering to good manufacturing practices and CLIA/CAP guidelines.

What You Will Do

• Responsible for day-to-day staffing/scheduling/setting up sample run schedules.
• Ensures production work is consistently completed according to department goals.
• Ensures all case samples are processed and accounted for.
• Monitors team members to ensure adherence to SOPs and safety procedures.
• Oversees training for new hires: works in conjunction with lead to train new hires.
• Document nonconformance reports and all corrective actions taken when test systems deviate from the established performance specifications as needed. Escalates protocol deviation to lead/supervisor.
• Handles employee issues. Collaborates with Manager and/or Human Resources to resolve issues.
• Assists manager in initiating and completing CAPAs.
• Ensures alignment with team for reasoning behind instructions/processes and changes.
• Meets regularly with individual team members to discuss goals and progress.
• Responsible for staff performance reviews.
• Plans and leads shift meetings.
• Maintains team morale and professionalism of team members, including by acting as role model. Adheres to Departmental Expectations.
• Ensures compliance with all regulatory agency requirements through documentation, audits, and corrective action. Go-to person when manager is not present.
• May assist lab team in day to day tasks.
• Keeps team morale up and maintains professionalism of team members, including by acting as role model.
• Assists the team in day to day lab work if necessary.
• Approves timecards and PTO requests.
• Escalates lab issues and team concerns to manager. Communicates the problem and suggests possible solutions.
• Understands the entire lab process and can identify and troubleshoot issues when they arise. Understands when and how to escalate issues appropriately.
• Makes sure the goals set by manager for the team are being met in the lab.
• Performs and completes side projects assigned by the manager.
• Actively interacts with interdepartmental teams such as OPS, Accessioning, Engineering, Stats, R&D, and Support.
• Receives assignments in the form of objectives with goals and the process by which to meet goals.
• Provides direction to employees according to established policies and management guidance. Administers company policies that directly affect subordinate employees.
• Recommends changes to unit or sub-unit policies.
• Provides direct supervision to professional individual contributors and/or skilled, support individual contributors.
• Acts as advisor to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems.
• This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job.
• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on Natera training requirements.
• Employee must pass post offer criminal background check.
• Performs other duties as assigned.

What You Will Bring

• 6+ years of experience as a Medical Technologist or equivalent in a clinical laboratory environment.
• BS/BA degree (or equivalent) in Medical Technology, Biological Sciences, or a related field.
• Current MT/MLS/CLS certification preferable from ASCP, AMT, or AAB.
• Proven leadership experience.
• Able to take on projects with little supervision.
• Excellent interpersonal, communication, computer, troubleshooting, and pipetting skills.
• Experience in Molecular Biology.
• Excellent oral and written communication skills.
• Word processing and data management skills.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Duties typically performed in BSL-1 to 2 laboratories with potentially hazardous material Standing or sitting for long periods of time may be necessary
• Duties may require working weekends and overtime
• Must be able to lift boxes or supplies up to 35lbs
• Duties require wearing safety goggles, gloves, and laboratory coat.
• Duties may require exposure to cold air due to frequent accessing of refrigeration and/or freezer units.

Compensation & Total Rewards

This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.

This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including:

• Annual performance incentive bonus
• Long-term equity awards
• Comprehensive health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and company holidays
• Additional wellness and work-life benefits

Compensation Range

$91,100.00 - $100,000.00

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information:

- BBB announcement on job scams

- FBI Cyber Crime resource page

Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and...

About usBeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide.

Hi, we’re Oscar. We’re hiring a Market Medical Officer, Atlantic to join our Clinical Affairs team.

Oscar is the first health insurance company built around a full stack technology platform and a relentless focus on serving our members. We started Oscar in 2012 to create the kind of health insurance company we would want for ourselves—one that behaves like a doctor in the family.

About the role:

The Market Medical Officer is the clinical executive for the Atlantic region, partnering with P&L leadership to lead market performance, expand care access, and enhance affordability. You will optimize medical cost trends and reimbursement strategies to balance financial sustainability with plan performance. As the primary clinical liaison, the Market Medical Officer executes regional programs while seamlessly bridging corporate operations with local provider leadership.

You will report into our Vice President, Clinical Affairs.

Work Location: This position is fully remote and open to candidates residing in the U.S., excluding Alaska; Delaware; Hawaii; Louisiana; Montana; North Dakota; Oklahoma; West Virginia; Wyoming; and U.S. Territories. Daily work is completed from your home office, with occasional travel required for team meetings and company events. #LI-Remote

Pay Transparency: The base pay for this role in the states of California, Connecticut, New Jersey, New York, and Washington is: $290,628- $381,449 per year. The base pay for this role in all other locations is: $261,565 - $343,304 per year. You are also eligible for employee benefits, participation in Oscar’s unlimited vacation program, company equity grants and annual performance bonuses.

Responsibilities:

• Drive performance of key clinical metrics for trend management and market performance of plans in their region including but not limited to ED/K, APK, ALOS and others in partnership with market P&L leadership.
• Work in partnership with Med Econ to identify market based utilization trends and flares and develop solutions to address key drivers to reduce overall spend.
• Build strategic partnerships with health systems, physician groups, and community providers to align incentives and lower the total cost of care.
• Serve as regional clinical partner across internal teams, partnering closely with Affordability, Utilization Management (UM), Care Management (CM), Claims, and others to drive regional performance goals.
• Partner with Network Contracting leadership to guide clinical initiatives that enhance provider alignment, care quality, and clinical outcomes across the region.
• Proactively identify and resolve regional network gaps and access barriers to advance equitable, high-quality care across all member populations.
• Collaborate with regulatory agencies and compliance teams to ensure regional network adequacy and quality programs comply with state and federal requirements, translating policy changes into proactive operational strategy that protect member access and organizational performance.
• Serve as the point of accountability for regional escalations, including internal/external appeals, provider and member grievances, and complex case management scenarios.
• Compliance with all applicable laws and regulations.
• Other responsibilities as assigned.

Requirements:

• 12+ years of progressive leadership experience in healthcare.
• 10+ years of experience in managed care with prior experience leading in a matrix environment.
• 7+ years of experience of clinical leadership in role specific market.
• 7+ years of experience managing clinical market trend in health insurance or full risk bearing clinical provider groups.
• 5+ years of clinical practice and board certified in one of the following fields: internal medicine, family medicine, general surgery, emergency medicine (other fields will be considered).
• 5+ years of experience leading teams.

Education:

• MD or DO with a current unrestricted license to practice medicine is required in a state in the region (GA, NC, SC, NJ, NY, PA, VA)

License and Certification:

• Reviewers must maintain necessary credentials to retain the position including maintaining active board certification.
• Willing and able to obtain additional state licensure (with Oscar’s support).

Bonus points:

• P&L experience for risk bearing entity.
• Licensure in multiple Oscar states.
• Masters degree or advanced certificate.
• Prior experience with Utilization management.

This is an authentic Oscar Health job opportunity.

At Oscar, being an Equal Opportunity Employer means more than upholding discrimination-free hiring practices. It means that we cultivate an environment where people can be their most authentic selves and find both belonging and support. We’re on a mission to change health care – an experience made whole by our unique backgrounds and perspectives.

Pay Transparency: Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience. Full-time employees are eligible for benefits including: medical, dental, and vision benefits, 11 paid holidays, paid sick time, paid parental leave, 401(k) plan participation, life and disability insurance, and paid wellness time and reimbursements.

Artificial Intelligence (AI): Our AI Guidelines outline the acceptable use of artificial intelligence for candidates and detail how we use AI to support our recruiting efforts.

Reasonable Accommodation: Oscar applicants are considered solely based on their qualifications, without regard to applicant’s disability or need for accommodation. Any Oscar applicant who requires reasonable accommodations during the application process should contact the Oscar Benefits Team (accommodations@hioscar.com) to make the need for an accommodation known.

California Residents: For information about our collection, use, and disclosure of applicants’ personal information as well as applicants’ rights over their personal information, please see our Privacy Policy.

While this is a remote position, candidates must reside in or be willing to relocate to one of the following states prior to their start date: Colorado, Connecticut, District of...

Do you crave an intellectually stimulating role that lets you apply your clinical expertise while continuing to grow and make an impact?

Ascend Healthcare is committed to providing fully integrated, quality psychiatric and behavioral health services in a compassionate, convenient, and affordable manner.  We work with external partners to provide services to patients across the country through integrated psychiatric medication management, substance use disorder treatment, counseling services, peer support and care coordination for seamless patient care. We believe in a “no wrong door” treatment model which finds ways to say “yes” to any patient referral rather than a multitude of exclusionary criteria found elsewhere. This approach reflects our values of improved patient and clinician experience, better outcomes, and lower costs.

The Ascend Story

Founded to transform mental health care access, Ascend Healthcare delivers integrated psychiatric and behavioral health therapy solutions with a commitment to equity, compassion, and operational excellence.We partner directly with health centers to build fully integrated, sustainable behavioral health programs—bringing deep clinical expertise, operational support, and long-term stability.

Our work environment fosters:

• Collaboration and teamwork
• Patient-First Mindset
• Work from home opportunities
• Career Growth and Professional Development Training

Why Ascend?

You’ll be joining a team delivering innovative, compassionate care to communities that need it most. At Ascend, your work drives real impact—and your career grows alongside it. We believe in a “no wrong door” treatment model that finds ways to say “yes” to any patient referral rather than a multitude of exclusionary criteria found elsewhere.

Position Overview:

The Therapy Team Lead provides direct patient care while managing an assigned team of Therapists at their designated CHC site. The Team Lead serves as the first point of contact for clinical and operational issues, monitoring performance metrics such as schedule utilization, encounter completion, documentation timeliness, and collaborating with cross-functional leadership to align team performance with organizational goals. The Team Lead also supports onboarding, provider engagement, and workflow optimization to ensure effective integration and consistency across the assigned team. While the position has direct oversight of a team of Therapists, the position may also assist with projects and operations within other service lines as needed. This role balances clinical responsibilities with leadership duties focused on provider support, quality assurance, and operational efficiency.

Key Areas of Ownership:

• Provide direct patient care within the Ascend model, maintaining a clinical schedule that balances administrative duties, as determined by organizational leadership. The team lead position is slated for 80% to 85% direct patient care,15% to 20% administrative responsibilities. This is subject to change as the company needs evolve.
• Oversight of assigned Therapy direct reports by monitoring productivity, documentation timeliness, and schedule utilization; serve as the first point of escalation for operational efficiencies.
• Support onboarding initiatives and integration of new Therapists.
• Provide proactive coaching, conduct bi-annual performance evaluations, and assist with professional development opportunities, ensuring a consistent level of accountability is maintained related to patient impact and quality of care.
• Address routine clinical questions when appropriate, while ensuring providers follow supervision and CEED guidance channels.
• Participate in training, orientation, and quality assurance initiatives, including chart reviews, to ensure documentation is accurate and meets regulatory compliance.
• Contribute to policy and procedure development, compliance initiatives, and timely resolution of patient complaints.
• Coordinate with Clinical Operations, CEED, Clinical Supervisors and Therapy leadership to optimize interdisciplinary workflows and training programs.
• Perform additional leadership and operational responsibilities as assigned.

Qualifications:

• Active and unrestricted independent license (LCSW, LPC, LMFT) in state of primary residence and state of therapy services being rendered. (required)
• 3+ years of clinical experience in behavioral health (required)
• Board-certified to provide clinical supervision (required)
• Prior leadership experience (required)
• Prior policy and procedure development experience (preferred)

Physical Requirements: This is a fully remote position but may require in-person attendance as company needs arise. Please be aware the below physical requirements should be considered prior to applying to the position:

• Prolonged Sitting: Ability to sit for extended periods during working hours.
• Manual Dexterity: Good hand-eye coordination and manual dexterity for using a computer keyboard, mouse, and other office equipment.
• Visual Requirements: Adequate vision for reading computer screens and documents.
• Communication: Clear verbal and written communication skills for virtual meetings and correspondence.
• Hearing: Sufficient hearing ability for participating in phone calls or virtual meetings.
• Work Environment: Access to a quiet, dedicated workspace free from distractions with reliable internet connectivity.

Perks

• Competitive Salary
• Medical, Dental, Vision, Life and LTD benefits
• PTO + Company Holidays
• Yearly CEU Stipend
• Collaborative Environment
• Remote-first setting

Benefits:

• 401(k)
• 401(k) matching
• Dental Insurance
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• Monday-Friday, 8am-5pm with 1 day per week being 10am-7pm

Base Compensation: $88,000-$96,000

Ascend Healthcare Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Ascend Healthcare participates in conducting comprehensive background checks and drug screenings for all potential employees as a contingency to gaining employment status.

Ascend Healthcare is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Ascend Healthcare participates in conducting comprehensive background checks and drug screenings for all potential employees as a contingency to gaining employment status.

Arvinas is a biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC Discovery Engine platform to engineer PROteolysis TArgeting Chimeras, or PROTACs, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins.

This differentiated approach has enabled Arvinas to build a broad pipeline of investigational therapies across oncology and neurodegenerative diseases, including ARV-102, targeting LRRK2 for neurodegenerative diseases; ARV-806, targeting KRAS G12D for mutated cancers, including pancreatic, colorectal, and non-small cell lung cancers; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; ARV-027, targeting the polyglutamine-expanded androgen receptor, or polyQ-AR, in skeletal muscle for spinal bulbar muscular atrophy; and vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer.

Building on its leadership in targeted protein degradation, Arvinas achieved a major milestone in May 2026 with the first-ever U.S. Food and Drug Administration (FDA) approval of a PROTAC protein degrader therapy. The approval marked a significant advancement for the field and demonstrated the therapeutic potential of targeted protein degradation as a novel treatment modality. This PROTAC has been out-licensed for commercialization and further development.

#TeamArvinas is made up of passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and mission – to improve the lives of patients with serious diseases by pioneering therapies created with our revolutionary PROTAC protein degradation platform. We’re really excited about the work we’re doing inside and outside of Arvinas, and think you will be, too. But don’t just take our word for it – learn more about life at Arvinas and what employees have to say.

Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X.

Position Summary

The Senior Director, Clinical Scientist is responsible for providing scientific and clinical leadership for global clinical development activities in neurodegenerative disease, with an initial focus on Parkinson’s disease and progressive supranuclear palsy (PSP). The role will assemble, evaluate, interpret, and present scientific and medical data; lead or provide content for clinical documents; monitor the competitive landscape; critically review relevant literature; and provide strategic input to clinical development programs and studies.

The successful candidate will combine a strong scientific background with substantial clinical-development experience, preferably including leadership of global early-phase, proof-of-mechanism, and proof-of-concept studies in neurodegenerative disease. Experience translating emerging safety, pharmacokinetic, pharmacodynamic, biomarker, imaging, and clinical data into dose selection, study-design, and program decisions is particularly important. The individual must communicate complex concepts clearly in writing and in formal presentations to scientific and medical experts inside and outside Arvinas. This role requires creativity, independence, strong strategic insight, attention to detail, and comprehensive knowledge of the activities and procedures involved in clinical drug development.

This is a senior leadership role requiring program-level scientific ownership, independent judgment, and the ability to influence cross-functional and governance decisions. The Senior Director will collaborate with Clinical Operations, Biostatistics, Data Management, Translational Sciences, Clinical Pharmacology, Pharmacovigilance, Regulatory, Research, and other functions within Arvinas, as well as investigators, vendors, partners, and external experts. Working closely with the Clinical Development Lead, the Senior Director will have a substantial role in development strategy, study design and execution, clinical document development, review and interpretation of clinical data, and communication of results to scientific, medical, regulatory, and patient communities.

This position reports to the Head of Clinical Sciences and can be hybrid at our headquarters in New Haven, CT, or remote from a location within the U.S.

Principal Responsibilities

Key responsibilities of this role include, but are not limited to:

Clinical Development Strategy and Study Planning

• Provide clinical-science leadership for clinical development plans, target product profiles, indication strategies, evidence-generation plans, and program-level decision making in Parkinson’s disease, PSP, and related neurodegenerative disorders.
• Partner with the clinical research physician to design global Phase 1-3 studies, with particular emphasis on early-phase, proof-of-mechanism, and proof-of-concept development, including population and disease-stage definitions, dose and regimen selection, estimands, endpoints, visit schedules, safety monitoring, biomarker and imaging plans, and participant/caregiver burden.
• Guide selection and interpretation of relevant outcome measures, including the MDS-UPDRS, PSP Rating Scale, clinical global assessments, cognitive and functional measures, quality-of-life instruments, patient- and caregiver-reported outcomes, and digital measures, as applicable.
• Contribute to data-collection tools, statistical analysis plans, case report forms, data-review plans, rater-training plans, and endpoint-quality strategies.
• Collaborate with cross-functional study teams to enable timely study start-up, including CRO and vendor selection, central laboratory and imaging onboarding, rater qualification mechanism, and Data Monitoring Committee or other independent committee activities.

Clinical Document Development

• Lead development of clinical study protocol synopses and full protocols, engaging internal and external subject-matter experts on study design, endpoints, biomarkers, and operational feasibility.
• Contribute to clinical portions of investigator brochures and review documents for scientific consistency, accuracy, and applicability.
• Lead or contribute to clinical study reports, development safety update reports, annual reports, regulatory briefing documents, responses to health-authority questions, and other clinical and regulatory deliverables.
• Contribute to development of internal and external presentations and publications, including abstracts, posters, manuscripts, congress presentations, advisory-board materials, and investigator-meeting content.
• Participate in publication planning and contribute to departmental working processes, standard operating procedures, templates, and best practices.

Study Conduct, Data Review, and Analysis

• Provide senior clinical-science leadership from study start-up through closeout, including support for investigator and site training, enrollment and retention strategies, eligibility review, protocol deviation assessment, and resolution of clinical and scientific questions.
• Lead development of medical monitoring and clinical data-review plans in partnership with the clinical research physician and safety colleagues.
• Perform ongoing review and critical analysis of blinded and unblinded efficacy, safety, biomarker, imaging, pharmacokinetic, and pharmacodynamic data; integrate emerging findings to support dose selection, escalation or expansion decisions, study adaptation, and program strategy; and identify trends, inconsistencies, and questions requiring cross-functional action.
• Responsible for processes for rater qualification, scale-administration standards, central review, inter-rater variability, data completeness, and missing-data mitigation in longitudinal neurodegeneration studies.
• Partner with Clinical Operations, Translational Sciences, Pharmacovigilance, Data Management, Biostatistics, Statistical Programming, and other functions to assure high-quality and timely study conduct, analysis, and reporting.
• Support interpretation and communication of emerging benefit-risk information and prepare clear data summaries and recommendations for senior leadership, governance committees, advisory boards, investigators, and regulators.

Scientific and External Engagement

• Perform literature searches and critically review and summarize scientific, drug-development, clinical, and regulatory literature to support protocols, investigator brochures, clinical study reports, competitive assessments, and development strategy.
• Monitor the neurodegeneration treatment landscape and emerging approaches in movement-disorder trial design, progression endpoints, biomarkers, imaging, digital measures, and patient-focused drug development.
• Build productive relationships with movement-disorder investigators, key opinion leaders, patient advocacy organizations, clinical research networks, and external partners; support advisory boards and investigator meetings.

Qualifications

• 10+ years of relevant pharmaceutical or biotechnology clinical-development experience, including substantial experience with global interventional studies and demonstrated leadership of early-phase clinical development; equivalent combinations of education and experience will be considered.
• Demonstrated clinical-development experience in neurodegenerative disease or movement disorders required, with meaningful experience in Parkinson’s disease, PSP, atypical parkinsonism, tauopathies, or closely related conditions strongly preferred.
• Strong knowledge of ICH-GCP, the drug-development process, study design, statistics, clinical operations, and global regulatory expectations in neurodegenerative disease required.
• Working knowledge of longitudinal efficacy endpoints, clinical rating scales, rater variability, disease progression, placebo effects, missing data, and operational challenges in neurodegeneration trials required.
• Excellent project leadership, communication, and organizational skills, with demonstrated success leading matrix teams, exercising independent judgment, and influencing program-level and cross-functional decisions.
• Ability to interpret complex clinical and biomarker data and communicate conclusions, limitations, and recommendations to technical and nontechnical audiences.
• Strong team orientation, passionate commitment to patients and caregivers, and ability to work independently and reliably deliver high-quality objectives on time.

Preferred Experience

• Demonstrated leadership of global early-phase clinical-development studies, including Phase 1, Phase 1b, or early proof-of-mechanism/proof-of-concept studies conducted across multiple countries or regions. Direct experience in neurodegenerative disease is strongly preferred.
• Experience designing or leading early-phase studies that integrate safety, pharmacokinetics, pharmacodynamics, biomarkers, imaging, dose and regimen selection, and preliminary clinical activity to inform study and program decisions.
• Direct experience with a global PSP or Parkinson’s disease study, including an early clinical-development or randomized proof-of-concept study. Experience with longer-term, placebo-controlled disease-progression studies is also desirable.
• Experience with relevant neurodegeneration endpoints and assessments, such as the PSP Rating Scale, MDS-UPDRS, cognitive and global assessments, quality-of-life measures, MRI or fluid biomarkers, and patient- or caregiver-reported outcomes.
• Experience with disease-modifying development programs and biomarker strategies involving tau, alpha-synuclein, lysosomal biology, genetically defined mechanisms, biologics, small molecules, or targeted protein degradation.
• Experience addressing the scientific and operational complexities of multinational studies, including regional differences in standard of care, site capabilities, rater qualification, endpoint implementation, participant and caregiver burden, and regulatory expectations. Experience with central or remote rater programs, digital biomarkers, wearable sensors, imaging endpoints, CSF sampling, independent monitoring committees, and interactions with FDA, EMA, or other health authorities is desirable.

Work Environment and Employment Requirements

The duties of this role are generally conducted in a home or corporate office environment. Employees must be able, with or without accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours. Domestic and international travel may be required, anticipated at approximately 20%.

Arvinas will not be providing visa sponsorship for this position now or in the future. Candidates must have the ability to work without a need for current or future visa sponsorship.

EDUCATION

• Advanced scientific or clinical degree required
• Doctoral-level degree such as PhD preferred. An MSc/MPH with extensive directly relevant experience may be considered.

#LI-Remote

Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com

Arvinas is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, disability or protected veteran status.

Ascend Healthcare is committed to providing fully integrated, quality psychiatric and behavioral health services in a compassionate, convenient, and affordable manner.  We work with external partners to provide services to patients across the country through integrated psychiatric medication management, substance use disorder treatment, counseling services, peer support and care coordination for seamless patient care. We believe in a “no wrong door” treatment model which finds ways to say “yes” to any patient referral rather than a multitude of exclusionary criteria found elsewhere. This approach reflects our values of improved patient and clinician experience, better outcomes, and lower costs.

The Ascend Story

Founded to transform mental health care access, Ascend Healthcare delivers integrated psychiatric and behavioral health solutions with a commitment to equity, compassion, and operational excellence.We partner directly with community health centers to build fully integrated, sustainable behavioral health programs—bringing deep clinical expertise, operational support, and long-term stability.

Our work environment fosters:

• Collaboration and teamwork
• Patient-First Mindset
• Work from home opportunities
• Career Growth and Professional Development Training

Why Ascend?

You’ll be joining a team delivering innovative, compassionate care to communities that need it most. At Ascend, your work drives real impact—and your career grows alongside it. We believe in a “no wrong door” treatment model that finds ways to say “yes” to any patient referral rather than a multitude of exclusionary criteria found elsewhere.

Position Overview:

The Director of Clinical Operations provides leadership and oversight of psychiatry and therapy service lines across assigned community health center(s) and partnerships. This role is accountable for operational execution, clinical program oversight, contract performance, and partner engagement while ensuring scalable systems that support organizational growth. As a clinical leader, the Director fosters high-quality care delivery across assigned site(s) and collaborates with the Clinical Education & Excellence Department, CMO, and CCO, to align training, standards, and program development. This role reports to the COO.

Key Areas of Ownership:

Clinical & Program Leadership

• Provide direct leadership and oversight for psychiatry, therapy, and support (MA, BHT etc.) service lines at assigned CHCs.
• Ensure evidence-based practices and clinical standards are consistently applied.
• Collaborate with the Clinical Education & Excellence team (including CMO and CCO) to align training, quality improvement, and staff development initiatives.
• Support clinical managers in handling escalations and building effective leadership capacity.
• Provide direct patient care within licensure scope (~10-15 hrs per week, as determined by organizational needs).

Operational Excellence

• Monitor and drive productivity, slot utilization, and workflow efficiency across assigned CHCs.
• Standardize processes and deploy best practices to ensure consistency and scalability.
• Act as the EMR expert for assigned systems, ensuring proper training, utilization, reporting, and data integrity.
• Establish accountability structures for managers and clinicians to achieve defined performance goals.
• Report on operational outcomes, productivity metrics, and contract performance to senior leadership.
• Support CHC compliance requirements, including provider credentialing, onboarding, and regulatory alignment.

Integration & Strategic Growth

• Facilitate partner meetings to align expectations, strengthen relationships, and drive contract success.
• Identify opportunities for program expansion and growth within existing partnerships.
• Partner with leaders across Ascend to ensure business continuity and support organizational growth.
• In collaboration with the implementation team, lead the clinical and operational launch of new CHC partnerships as assigned.
• Support budget planning and contract strategy development.

Qualifications:

• Board Certified and Independently Licensed as a:
  • Physician Assistant (PA-C) or Nurse Practitioner (PMHNP)
• Must have 2+ years of Psychiatry/ Behavioral Health experience
• Active, unrestricted clinical license in state of primary residence and state of medical services being provided.
• Must have demonstrated leadership experience overseeing clinical operations and staff management.
• Experience in EMR systems, data-driven reporting, and workflow optimization.
• Experience working with Federally Qualified Health Centers (FQHCs) - preferred

Physical Requirements: This is a fully remote position but may require in-person attendance as company needs arise. Please be aware the below physical requirements should be considered prior to applying to the position:

• Prolonged Sitting: Ability to sit for extended periods during working hours.
• Manual Dexterity: Good hand-eye coordination and manual dexterity for using a computer keyboard, mouse, and other office equipment.
• Visual Requirements: Adequate vision for reading computer screens and documents.
• Communication: Clear verbal and written communication skills for virtual meetings and correspondence.
• Hearing: Sufficient hearing ability for participating in phone calls or virtual meetings.
• Work Environment: Access to a quiet, dedicated workspace free from distractions with reliable internet connectivity.

Perks

• Competitive Salary
• Medical, Dental, Vision, Life and LTD benefits
• PTO + Company Holidays
• Yearly CEU Stipend
• Collaborative Environment
• Remote-first setting
• Clinician Founded and Operated
• Incentive Bonus Program

Schedule: Monday- Friday, 8am-5pm (Timezone pending clinic assignment)

Base Comp: $180,000-$190,000

Benefits:

• 401(k)
• 401(k) matching
• Dental Insurance
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Ascend Healthcare is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Ascend Healthcare participates in conducting comprehensive background checks and drug screenings for all potential employees as a contingency to gaining employment status.

Do you crave an intellectually stimulating role that lets you apply your clinical expertise while continuing to grow and make an impact?

Career CategoryClinicalJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are.

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision cell therapies we hope to not only replace patients’ blood and immune systems with healthy ones, but also restore their lives.

Position Summary: Reporting to our Chief Development Officer, the Director/Head of Pharmacovigilance will lead and develop the safety function, providing direct guidance to a small, dedicated team while driving end-to-end operational oversight.

Key Responsibilities

• Lead risk management and mitigation activities for assigned products, leading safety data review and analysis for all products.
• Responsible for providing safety-related content for all clinical and regulatory documents.
• Lead inspection preparedness efforts for pharmacovigilance and represent Orca’s pharmacovigilance organization at regulatory inspections.
• Stay abreast of changes in regulations, leading updates to SOPs and other documentation to address any process gaps.
• Identify and address resource and infrastructure needs, contribute to departmental budgets and planning to align with Orca products’ stage of development.
• Represent product safety in the cross-functional team environment.
• Lead safety governance activities in collaboration with medical monitors and leadership.
• Lead safety related activities for regulatory filings including development of meeting request and briefing book content, SAP and TFL review, signal detection and risk identification, responses to regulatory queries, RMPs, REMs, ISS strategy, and regional safety related labeling activities.
• Provide guidance and mentorship to all direct reports within the pharmacovigilance function, including support and oversight of operations.

Qualifications

• Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner, MD, or PhD.
• 10+ years of experience in drug safety, safety science and risk management at a pharmaceutical, biotech, or CRO, including people leadership experience.
• Knowledge of US and EU safety regulations pre and post marketing pharmacovigilance requirements.
• Experience with pharmacovigilance risk management, preferably at a commercial-stage company.
• Proficiency in preparing pre-marketing and post marketing safety regulatory documents, including PSURs, PBRERs, PADER, and Risk Management Plans.
• Experience with clinical development, risk/benefit analysis, and safety assessment.
• Strong clinical, analytical, problem-solving, scientific writing, and communication skills.
• Prior experience working on a BLA/NDA. Prior experience leading risk management activities for a BLA/NDA preferred.
• Hands-on mentality, ability to operate in a small biotech environment.
• Knowledge of cell therapy, bone marrow transplant or hematology oncology is a plus.
• Expertise in analyzing safety data from clinical and safety databases.
• Experience in MedDRA coding and search strategies.
• Excellent independent judgment based on knowledge and expertise.
• Strong personal time management and project management skills.

$200,000 - $245,000 a year

The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

About Ceribell

Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephalography (“EEG”) platform specifically designed to address the unmet needs of patients in the acute care setting, and is being used in hundreds of community hospitals, large academic facilities and major IDN’s across the country. Our entire team is driven by a shared commitment to transforming the landscape of critical care through our rapid seizure detection technology, come join the movement!

The Medical Director will be a key member of the management team, providing medical oversight, expertise, and leadership to support Ceribell’s strategy to expand clinical indications, develop new products, and implement clinical trials to continue to build evidence to support market adoption. The Medical Director will be a visible advocate for driving education and awareness on how neurological patients in the ICU and the floor are monitored and diagnosed, helping healthcare providers monitor and reduce time from ordering an EEG to set-up from an average of 4 hours to under 10 minutes. They will be an important spokesperson, including providing guidance on neuro-critical health-related matters with key opinion leaders at scientific conferences and advisory boards defining global standards of care for patients. S/he will have the credibility, experience, and relationships to drive initiatives and results.

What You Will Do

Strategy

• Lead medical strategy and planning
• Support clinical, marketing, and product strategy

Execution

• Peer-to-peer engagement through sales (~70% time)
  • Working with sales to directly engage customers from pre-PO sales process, through hospital executive engagements, to workflow discussions
  • Educating the sales team on how to better engage customers (1-on-1 and directly working with sales trainer and sales leadership)
  • Developing other physician advocates for Ceribell so that these advocates can engage and present our products to more physicians
• Peer-to-peer engagement through marketing (10%)
  • Support marketing in engaging different societies
  • Support advisory board
  • Give talks and webinars representing Ceribell
• Evidence generation - support evidence generation and publications (10%)
  • Partner with clinical and marketing teams on post-market evidence:
    • Publication strategy and execution
    • Retrospective study strategy, design, and execution
    • Investigator-initiated study management and support
  • Identify and develop KOL and physician relationships:
    • To select appropriate partners for sponsored clinical trials and studies
    • To develop a network or fellows or residents who can assist with research and writing for Ceribell
  • Regulatory trials – support clinical/reg/R&D/Product team to design trials for data collection or approval by providing the medical expertise
  • Keep the organization updated with the latest literature
    • Identify key evidence or medical opportunities for the company
• Provide medical expertise for cross-functional teams (10%)
  • To Product and R&D teams on future product development
  • To Regulatory and Reimbursement teams by interfacing with FDA and payers

What You Bring

• MD, DO or MD/PhD degree required
• An experienced Neurologist or Intensivist with at least 10 years of experience in industry or as an attending physician. The Company is open to having a full-time Neurologist or Intensivist with direct experience in industry as or alternatively, an attending Neurologist or Intensivist who can spend 50% of his/her time with Ceribell and 50% with their practice.
• Critical care experience required
• Experience with the Ceribell platform
• Experience and strong knowledge of neurological assessment and acute care workflow – highly desired.
• Analytical and strategic thinking capabilities along with good judgment and decision-making skills balanced with high degree of EQ and well-balanced ego.
• A dedication to integrity, transparency and honesty is a must; an informal, direct personal style and a flexible approach are highly desirable attributes.
• Data driven mindset with the capability to envision the application of new technologies in novel ways to solve complex patient needs.
• A commercially oriented mindset is important. S/he should have a strong understanding of the product commercialization pathway and be able to add value to general business strategy.
• Expertise in presenting breakthrough products and new technologies to physicians.
• Highly developed understanding of the external marketplace and medical literature to serve as a valuable key member of the executive team with the ability to bring medical and/or clinical knowledge to the analysis of the Company’s future commercial opportunities.
• Excellent written, verbal communication, influence/leadership, and presentation skills to various audiences, particularly neurologists and intensivists as well as the ICU and other hospital administrators.
• Ability to make reasonable tradeoffs and manage multiple priorities in a fast-paced, data driven entrepreneurial environment.
• Creative and critical intellect with a ‘what if’ openness to new ideas and “thinks large”. Generates ideas/opportunities and turns them into successful results. Flexible about implementation while being inflexible about the quality and timeliness of results.
• A results-oriented executive who conveys a sense of urgency and drives for closure. Able to execute and prioritize multiple, competing tasks and demands. Recognizes and executes critical details.
• Effective collaborative interpersonal skills: persuasive, generates enthusiasm, credible at all levels of the organization.
• Comfortable and productive with rapidly changing organizational needs and adept at managing in a start-up resource environment.
• Assist in formulating a process that adds a business and market component to prioritizing research projects.
• Ability to interface effectively with all levels and functions within the organization, as well as the Company’s Board of Directors.
• Experience as a respected senior clinical/medical leader with an excellent working relationship with the FDA including a successful history of effective collaboration through clinical studies, market release and post- marketing activities.
• Significant experience in relating to marketing and business issues with a focus on clinical and medical support of commercial assets.
• Broad contacts in academic medical centers, major practice centers, and the medical device industry
• Location: Remote (US-Based)
• Travel required: Up to 40% travel required (typically 2 days per week)

This job description is not intended to be all-inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the organization.

Compensation Range

$300,000—$309,000 USD

A candidate’s final salary offer will be based on their skills, education, work location and experience, and thus it may differ from the posted range. Compensation may also include bonuses consistent with Ceribell’s corporate compensation plan. Note, the above description is not all-encompassing and Ceribell reserves the right to change or modify job duties and assignments at any time.

In addition to your base compensation, Ceribell offers eligible employees the following:

• Performance-based incentive compensation (varies by role)
• Equity opportunities
• 100% Employer paid Health Benefits for Employees
• 50% - 70% Employer paid Health, Dental & Vision for dependents (depending on plan selection)
• 100% paid Life and Long-Term Disability Insurance
• 401(k) with a generous company match
• Employee Stock Purchase Plan (ESPP) with a discount
• Monthly cell phone stipend
• Flexible paid time off
• 13 Paid Holidays + 3 Company Wellness Days
• Excellent parental leave policy
• Fantastic culture with tremendous career advancement opportunities
• Joining a mission-minded organization!

Application Deadline: Ongoing

Other Job Details Ceribell reports transfers of value to health care providers (HCPs) as required by federal and state transparency laws. These laws and implementing regulations require Ceribell to provide government agencies with HCPs’ names, addresses and the type of payments or other value received, generally for public disclosure. If you are an HCP and we pay or reimburse your recruiting expenses as a result of interviewing with Ceribell, your name, address and the amount of payments made may be reported to the government.

Equal Opportunity Employer Ceribell is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity or expression, national origin, age, marital status, disability, veteran status or any other characteristic protected by law. Ceribell complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Ceribell is an E-Verify employer. Any applicant with a disability who requires an accommodation during the application process should contact talent@ceribell.com to request reasonable accommodation.

Privacy Statement For information on how Ceribell processes personal data of job applicants, please review our Privacy Policy.

Compliance Disclaimer If you believe this job posting is non-compliant, please submit a report to legal@ceribell.com. Please note that we will not respond to inquiries unrelated to job posting compliance.

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision cell therapies we hope to not only replace patients’ blood and immune systems with healthy ones, but also restore their lives.

Position Summary: Reporting to our Chief Development Officer, the Director/Head of Pharmacovigilance will lead and develop the safety function, providing direct guidance to a small, dedicated team while driving end-to-end operational oversight.

Key Responsibilities

• Lead risk management and mitigation activities for assigned products, leading safety data review and analysis for all products.
• Responsible for providing safety-related content for all clinical and regulatory documents.
• Lead inspection preparedness efforts for pharmacovigilance and represent Orca’s pharmacovigilance organization at regulatory inspections.
• Stay abreast of changes in regulations, leading updates to SOPs and other documentation to address any process gaps.
• Identify and address resource and infrastructure needs, contribute to departmental budgets and planning to align with Orca products’ stage of development.
• Represent product safety in the cross-functional team environment.
• Lead safety governance activities in collaboration with medical monitors and leadership.
• Lead safety related activities for regulatory filings including development of meeting request and briefing book content, SAP and TFL review, signal detection and risk identification, responses to regulatory queries, RMPs, REMs, ISS strategy, and regional safety related labeling activities.
• Provide guidance and mentorship to all direct reports within the pharmacovigilance function, including support and oversight of operations.

Qualifications

• Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner, MD, or PhD.
• 10+ years of experience in drug safety, safety science and risk management at a pharmaceutical, biotech, or CRO, including people leadership experience.
• Knowledge of US and EU safety regulations pre and post marketing pharmacovigilance requirements.
• Experience with pharmacovigilance risk management, preferably at a commercial-stage company.
• Proficiency in preparing pre-marketing and post marketing safety regulatory documents, including PSURs, PBRERs, PADER, and Risk Management Plans.
• Experience with clinical development, risk/benefit analysis, and safety assessment.
• Strong clinical, analytical, problem-solving, scientific writing, and communication skills.
• Prior experience working on a BLA/NDA. Prior experience leading risk management activities for a BLA/NDA preferred.
• Hands-on mentality, ability to operate in a small biotech environment.
• Knowledge of cell therapy, bone marrow transplant or hematology oncology is a plus.
• Expertise in analyzing safety data from clinical and safety databases.
• Experience in MedDRA coding and search strategies.
• Excellent independent judgment based on knowledge and expertise.
• Strong personal time management and project management skills.

$200,000 - $245,000 a year

The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision cell therapies we hope to not only replace patients’ blood and immune systems with healthy ones, but also restore their lives.

Position Summary: Reporting to our Chief Development Officer, the Director/Head of Pharmacovigilance will lead and develop the safety function, providing direct guidance to a small, dedicated team while driving end-to-end operational oversight.

Key Responsibilities

• Lead risk management and mitigation activities for assigned products, leading safety data review and analysis for all products.
• Responsible for providing safety-related content for all clinical and regulatory documents.
• Lead inspection preparedness efforts for pharmacovigilance and represent Orca’s pharmacovigilance organization at regulatory inspections.
• Stay abreast of changes in regulations, leading updates to SOPs and other documentation to address any process gaps.
• Identify and address resource and infrastructure needs, contribute to departmental budgets and planning to align with Orca products’ stage of development.
• Represent product safety in the cross-functional team environment.
• Lead safety governance activities in collaboration with medical monitors and leadership.
• Lead safety related activities for regulatory filings including development of meeting request and briefing book content, SAP and TFL review, signal detection and risk identification, responses to regulatory queries, RMPs, REMs, ISS strategy, and regional safety related labeling activities.
• Provide guidance and mentorship to all direct reports within the pharmacovigilance function, including support and oversight of operations.

Qualifications

• Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner, MD, or PhD.
• 10+ years of experience in drug safety, safety science and risk management at a pharmaceutical, biotech, or CRO, including people leadership experience.
• Knowledge of US and EU safety regulations pre and post marketing pharmacovigilance requirements.
• Experience with pharmacovigilance risk management, preferably at a commercial-stage company.
• Proficiency in preparing pre-marketing and post marketing safety regulatory documents, including PSURs, PBRERs, PADER, and Risk Management Plans.
• Experience with clinical development, risk/benefit analysis, and safety assessment.
• Strong clinical, analytical, problem-solving, scientific writing, and communication skills.
• Prior experience working on a BLA/NDA. Prior experience leading risk management activities for a BLA/NDA preferred.
• Hands-on mentality, ability to operate in a small biotech environment.
• Knowledge of cell therapy, bone marrow transplant or hematology oncology is a plus.
• Expertise in analyzing safety data from clinical and safety databases.
• Experience in MedDRA coding and search strategies.
• Excellent independent judgment based on knowledge and expertise.
• Strong personal time management and project management skills.

$200,000 - $245,000 a year

The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

Notice to staffing firms

Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.