- Location
- Princeton, New Jersey, United States, South San Francisco, California, United States · Princeton, New Jersey, United States
- Department
- 215 Clinical Development
- Seniority
- VP
- Experience
- 10+ years
- Education
- PhD
- Source
- Greenhouse
Description
About Us
The VP, Clinical Development will have direct responsibility as Clinical Lead accountable for clinical development strategy and execution across one or more programs.
The successful candidate will be a highly credible physician leader, a strong people manager, and a trusted thought partner to the CMO, CEO, and Executive Committee.
Key Responsibilities
Program – Clinical Lead
- Serve as the Clinical Lead for the one or more programs, with end-to-end accountability for clinical strategy and execution, including protocol development and approval and regulatory interactions.
- Lead the Clinical Strategy Team (CST) with cross-functional leadership in development and execution of the clinical development plan
- Own clinical development plans, and protocol design, with critical input for indication selection and target product profile (TPP) development.
- Lead clinical decision-making based on emerging data, benefit–risk assessments, and evolving regulatory expectations.
- Act as the primary clinical development point of contact for regulatory interactions, investigators, and key opinion leaders.
- Partner closely with Development Operations, Biometrics, Regulatory, and Medical Affairs to ensure seamless execution.
Executive & External Engagement
- Act as a senior clinical representative in Executive Committee discussions, as appropriate.
- Present clinical strategy, progress, and risks to internal leadership and, when needed, the Board of Directors.
- Represent Kardigan clinical development externally at scientific meetings, advisory boards, and partner interactions related to the clinical program(s).
Qualifications
- MD (or equivalent medical degree); board certification strongly preferred.
- 10+ years of experience in clinical development within biotechnology and/or pharmaceuticals.
- Demonstrated experience serving as clinical lead for a major program or asset, ideally through key late stage development milestones.
- Strong understanding of clinical trial design, regulatory strategy, and benefit–risk assessment.
- Proven ability to influence and lead cross-functional teams.
- Experience in late-stage development and/or regulatory submissions.
- Prior experience managing or mentoring other MDs.
- Experience in a high-growth or emerging biotech environment.
- Track record of effective partnership with a CMO or senior medical leadership.
Leadership Characteristics
- Highly credible clinical development leader with strong clinical judgment.
- Strategic thinker who balances rigor with speed and pragmatism.
- Strong collaborator and people leader with extensive experience leading and building teams.
- Comfortable operating in ambiguity and helping design future-state organizations.
Exact Compensation may vary based on skills, experience and location.