VP, Clinical Development
Description
This is a unique opportunity for an experienced VP Clinical Development to join an attractive and well-funded clinical-stage biotech company that is focused on building a next-generation model for cardiovascular drug development and innovation. With a robust pipeline of precision therapies -- including multiple potentially transformative late-stage, 1st-in-class programs -- the company is entering a pivotal stage of growth and clinical advancement. Supported by a proven executive leadership team with an outstanding track record in this space, this company is well-positioned for tremendous success and expansion.
You will play a central role in shaping both the program/portfolio strategy and the long-term direction of the organization. This is a rare combination of meaningful program ownership, executive visibility, exceptional science, and a chance to influence portfolio and company strategy and help build a top-notch Clinical organization within one of the industry’s fastest growing biotech companies.
For a physician leader who enjoys building organizations, solving complex scientific challenges, and translating breakthrough science into transformative medicines in areas of significant unmet need, few opportunities offer this level of lasting impact.
Features
ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:
- Visibility, Autonomy, and Executive-level Influence: Work directly with the CMO, CEO, Executive Committee, shape development strategy, influence executive decision-making, and help bring innovative cardiovascular therapies to patients with significant unmet medical needs.
- Well-Funded Biotech with Long-Term Vision: Supported by a strong financial foundation, an expanding/differentiated pipeline, and a proven executive leadership team, the company offers the rare opportunity to pair true innovation with late-stage programs with the agility, visibility, and influence that only a focused biotech can provide.
- Make a Lasting Imprint: Your work here has the real potential to change how cardiovascular patients are treated for years to come. Instead of contributing to a program within a large organization, here you'd help define the future of an entire cardiovascular franchise and company. You'll have a seat at the table for clinical strategy, portfolio decisions, and organizational growth.
- Own Clinical Strategy for Flagship Late-Stage Program: This is a rare opportunity to own the end-to-end clinical development strategy & execution for a first-in-class program, and directly influence portfolio/company strategy.
- Highly Reputable Exec. Leadership: Work closely with an extremely accomplished Executive Leadership team with a proven track record of developing innovative medicines, advancing successful programs, and building high-performing biotech organizations.
Responsibilities
RESPONSIBILITIES IN A NUTSHELL:
- Serve as the Clinical Lead for a high priority late-stage cardiovascular program, with end-to-end accountability for clinical strategy and execution, including protocol development and approval and regulatory interactions.
- Own clinical development plans and protocol design, with critical input for indication selection and target product profile development.
- Lead the Clinical Strategy Sub-Team with cross-functional leadership in developing and executing an innovative clinical development plan.
- Lead clinical decision-making based on emerging data, benefit–risk assessments and evolving regulatory expectations.
- Act as a senior clinical representative in Executive Committee discussions.
- Partner closely with Development Operations, Biometrics, Regulatory, and Medical Affairs to ensure seamless execution.
- Present clinical strategy, progress, and risks to executive leadership and, when needed, the Board of Directors.
- Build trusted relationships with leading investigators and cardiovascular Key Opinion Leaders.
Qualifications / Requirements
DESIRED EXPERIENCE:
- Medical Degree is required; board certification is strongly preferred.
- 10+ years of relevant clinical drug development experience (primarily in Ph 2/3) working in the pharmaceutical/biotech industry.
- Demonstrated experience serving as clinical lead for a cardiovascular program or asset is strongly preferred.
- Strong understanding of clinical trial design, regulatory strategy, and proven ability to influence and lead cross-functional teams.
- Proven ability to work effectively in a fast-paced, high-growth or emerging biotech environment.
- Comfortable operating in ambiguity and helping design future-state organizations.
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