MD or equivalent medical degree; board certification preferred.
10+ years of clinical development experience in biotech/pharmaceuticals.
Experience as clinical lead for major programs through late-stage milestones.
Strong knowledge of clinical trial design and regulatory strategy.
Proven influence and leadership within cross-functional teams.
Experience in late-stage development or regulatory submissions.
Prior management or mentoring experience of MDs.
Responsibilities
Serve as core member and Clinical Lead for Tonlamarsen, overseeing clinical strategy and execution.
Lead TLA Clinical Strategy Sub-Team, executing the clinical development plan.
Design clinical development plans and protocols, focusing on indication selection and TPP.
Make clinical decisions based on emerging data and regulatory expectations.
Act as primary point of contact for regulatory, investigators, and opinion leaders regarding TLA.
Collaborate with Development Operations, Biometrics, Regulatory, and Medical Affairs for seamless execution.
Present clinical strategy and progress to internal leadership and the Board as necessary.
Benefits
On-site work four days a week (Mon to Thurs).
Opportunity to lead a high-impact program in a dynamic biotech environment.
Full Job Description
Position Title: VP Clinical Development, Tonlamarsen (TLA)
Department: Development
Reports To: Chief Medical Officer
Location: South San Francisco, CA or Princeton, NJ - On-site 4 days per week (Mon to Thurs)
The VP,Clinical Development, working closely with the Global Program Head (GPH), will have direct responsibility as Clinical Lead for the Tonlamarsen program accountable for clinical development strategy and execution across the TLA program.
The successful candidate will be a highly credible physician leader, a strong people manager, and a trusted thought partner to the GPH, CMO, CEO, and Executive Committee.
Key Responsibilities
Tonlamarsen Program - Clinical Lead
Serve as a core member of the Global Program Team (GPT) and Clinical Lead for the TLA program, with end-to-end accountability for clinical strategy and execution, including protocol development and approval and regulatory interactions.
Lead the TLA Clinical Strategy Sub-Team (CST) with cross-functional leadership in development and execution of the TLA clinical development plan.
Own clinical development plans, and protocol design, with critical input for indication selection and target product profile (TPP) development for TLA.
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 related to TLA.
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 TLA and as needed on other programs.
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.
