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 program GPH, other VP-CDLs, the CMO, the CEO, and Executive Committee members.
Key Responsibilities Danicamtiv Program - Clinical Lead - Serve as the Clinical Lead for the Danicamtiv program, with end-to-end accountability for clinical strategy and execution, including protocol development and approval and regulatory interactions.
- Lead the Danicamtiv Clinical Strategy Team (CST) with cross-functional leadership in development and execution of the Danicamtiv clinical development plan.
- Own clinical development plans, and protocol design, with critical input for indication selection and target product profile (TPP) development for Danicamtiv.
- Lead clinical decision-making based on emerging data, benefit-risk assessments and evolving regulatory interactions and expectations.
- Act as the primary clinical development point of contact for regulatory interactions, investigators, and key opinion leaders related to the Danicamtiv program.
- Partner closely with colleagues from Clinical Operations, Biometrics, Regulatory, and Medical Affairs to ensure seamless oversight and execution of clinical trials across the Danicamtiv program.
Executive & External Engagement - Act as a senior clinical representative for discussions with the Kardigan Executive Committee, as needed.
- Present clinical strategy, study progress, and risks to internal leadership and, when needed, to the Kardigan Executive Committee and Board of Directors.
- Represent the Kardigan clinical development function externally at scientific meetings, advisory boards, and interactions with Key Opinion Leaders, related to the Danicamtiv programs and potentially for other drug programs, as well.
Qualifications - MD (or equivalent medical degree); board certification and clinical practice experience in cardiology strongly preferred.
- 15+ years of experience in clinical development within biotechnology and/or pharmaceutical companies- experience in cardiomyopathy and/or heart failure drug development and deep knowledge of cardiomyopathy and heart failure clinical care delivery, clinical research landscape, scientific literature, competitive drug development environment, and regulatory pathways strongly preferred.
- Demonstrated experience serving as clinical lead for a major drug program or asset, ideally through key late-stage development milestones.
- Strong understanding of cardiovascular clinical trial designs, endpoints in cardiovascular trials, and regulatory strategies for cardiovascular drug development.
- Well-developed relationships with key external experts in the cardiomyopathy/heart failure field and demonstrated track record of overseeing external research collaborations for cardiomyopathy/heart failure topics.
- Experience with genetic screening initiatives for clinical research and clinical care delivery purposes desired.
- 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.
Pay range
$340,000-$416,000 USD
