Vice President, Clinical Development, Tonlamarsen (TLA)

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.