Vice President, Clinical Development

The role

The Vice President, Clinical Development serves as the Clinical Development Lead for the Danicamtiv program. This person will own the Clinical Development Plan, lead clinical protocol design, and provide matrix leadership for cross-functional teams.

What you will do

• Serve as the Clinical Development Lead for the Danicamtiv program.
• Own the Clinical Development Plan and clinical program strategy.
• Co-lead the Global Clinical Team and represent the clinical program in governance forums.
• Lead clinical protocol design and indication selection.
• Hold accountability for clinical program execution, budget, and timelines.
• Lead clinical decision-making based on emerging data and benefit-risk assessments.
• Partner with Clinical Operations, Biometrics, Regulatory Affairs, and Medical Affairs.
• Support Medical Affairs on publication planning and scientific communication.
• Line manage the Clinical Development Medical Director and the Clinical Scientist.
• Act as the primary clinical development point of contact for regulatory interactions.

Required qualifications

• MD (or equivalent medical degree)
• 10 - 15+ years of clinical development experience within biotechnology and/or pharmaceutical companies
• Substantial hands-on experience in biotech or emerging-company settings
• Substantial Phase 2b and Phase 3 experience
• Demonstrated experience serving as clinical lead for a major drug program or asset
• Demonstrated strength in protocol development including hands-on authorship
• Proven experience recruiting, managing, mentoring, and developing clinical development physicians and scientists
• Experience in a high-growth or emerging biotech environment
• Proven ability to lead cross-functional teams
• Proven leadership in managing a cross-functional, matrixed team to develop and implement a program-wide clinical development plan
• Deep end-to-end development experience
• Demonstrated success developing and defending regulatory strategy

Nice to have

• Board certification
• Clinical practice experience
• Cardiology or cardiometabolic specialization
• Experience taking a program through Phase 3 to registration/NDA

About the company

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. The company has a cutting-edge discovery and translational research platform and a pipeline of late-stage candidates.