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VP, Clinical Development

Artiva Biotherapeutics
3 months ago
Remote friendly (San Diego, CA)
United States
$350,000 - $415,000 USD yearly
Clinical Research and Development
Job Summary:
The Vice President, Clinical Development will provide strategical leadership across Artiva’s pipeline, ensuring regulatory alignment and cross-functional collaboration to advance clinical assets.

Duties/Responsibilities:
- Define and drive the clinical development strategy for assigned programs.
- Translate scientific, translational, and clinical data into development plans, milestone decisions, and risk-benefit assessments.
- Ensure alignment of clinical strategy with regulatory expectations, target product profiles, and long-term portfolio objectives.
- Lead the design and oversight of registration-quality clinical trials (endpoints, patient population strategy, global development considerations).
- Provide senior clinical oversight to meet registration standards for quality, safety, and data integrity.
- Partner with Biometrics and Regulatory Affairs to support statistical and regulatory requirements.
- Provide ongoing medical oversight of trials (safety monitoring, emerging data review, protocol amendments).
- Partner with Clinical Operations on feasibility, site strategy, enrollment planning, and CRO oversight.
- Review/interpret clinical data to guide program adjustments and development decisions.
- Ensure readiness for audits, inspections, and regulatory review.
- Represent Clinical Development in health authority interactions.
- Lead clinical components of submissions (briefing documents, regulatory question responses).
- Engage investigators/advisors/external experts to support strategy and execution.
- Collaborate with Translational Medicine, Safety/Pharmacovigilance, Regulatory Affairs, Biometrics, and CMC teams.
- Provide clinical input into biomarker strategy, safety strategy, and lifecycle planning.

Requirements:
- MD required.
- Board certification preferred.
- 15+ years of clinical development experience in biotech and/or pharma.
- Proven leadership of late-stage and registration-enabling trials, including global studies.
- Direct involvement in regulatory submissions (e.g., NDA, BLA, MAA) and health authority interactions.
- Experience applying pharma development practices in smaller/earlier-stage organizations.
- Background in immunology, autoimmune disease, or cell therapy required.
- Experience leading through key inflection points (e.g., EOP2, pivotal study initiation, registration readiness).
- Strong strategic thinking across clinical, regulatory, and scientific perspectives.
- Deep understanding of global clinical development and registration pathways.
- Sound clinical judgment and risk-benefit decision-making.
- Clear, credible communicator with regulators, investigators, executives, and cross-functional teams.
- Models transparency, collaboration, and patient-centric decision-making.

Benefits:
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays (including year-end holiday week)
- Bonus.ly recognition program

Compensation:
- Base Salary: $350,000 - $415,000 (varies by skills and experience).