About UsĀ
TheĀ VP,Ā ClinicalĀ DevelopmentĀ will have direct responsibility as Clinical Lead accountable for clinical development strategy and execution acrossĀ one or moreĀ programs.Ā
The successful candidate will be a highly credible physician leader, a strong people manager, and a trusted thought partner toĀ theĀ programĀ GPH, other VP-CDLs, theĀ CMO,Ā theĀ CEO, and Executive CommitteeĀ members.
Key ResponsibilitiesĀ
Danicamtiv Program ā Clinical LeadĀ
- 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, benefitārisk 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.Ā
Executive & External EngagementĀ
- Act as a senior clinical representative for discussions with the Kardigan Executive Committee, as needed.Ā
- Present clinical strategy, study progress, and risks to internal leadership and, when needed, to the Kardigan Executive Committee and Board of Directors.Ā
- Represent the Kardigan clinical development function externally at scientific meetings, advisory boards, and interactions with Key Opinion Leaders, related to theĀ Ā Danicamtiv programs and potentially for other drug programs, as well.Ā
QualificationsĀ
- MD (or equivalent medical degree); board certification and clinical practice experience in cardiology strongly preferred.Ā
- 15+ years of experience in clinical development within biotechnology and/or pharmaceutical companiesā 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.Ā
- 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. Ā
- 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.
Ā Leadership CharacteristicsĀ
- 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.
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