Clinical Development Strategist

1 week ago

California, United States Aura BioSearch Full time
Job Title: Vice President Clinical Development

Aura Biosearch is conducting an executive search on behalf of our client, a global leader in the biopharmaceutical industry focused on rare diseases.

Our client is committed to making a significant impact on the lives of individuals living with rare conditions. Their success is driven by a passionate team that meets the unique needs of rare disease patients, making the work both professionally and personally rewarding.

They are currently seeking highly skilled individuals who thrive in a dynamic, fast-paced, and collaborative environment to join their team in advancing life-changing therapies for rare diseases. The ideal candidate will share their mission and values, which are centered on patient focus and collaboration, as they pursue their vision of bettering patients' lives worldwide.

Job Summary:

Our client is searching for a Vice President of Clinical Development to serve as a key strategic partner to the Chief Medical Officer (CMO). This role will oversee the strategic planning and execution of the metabolic and nephrology programs while leading cross-functional Project Strategy Teams composed of Clinical Development Operations, Regulatory, CMC, Medical Affairs, Commercial, and Project Management.

The VP will be responsible for developing and implementing the global strategy for clinical development and commercialization of programs in the client's pipeline, including potential new programs. The ideal candidate should bring significant expertise in clinical development, particularly in nephrology and rare diseases, and have experience managing the full lifecycle of therapeutics from pre-IND to commercialization across multiple modalities.

Key Responsibilities:
  • Provide clinical leadership and strategic direction across all programs.
  • Lead the development of global strategic plans for clinical development towards successful commercialization.
  • Provide deep knowledge in core disease areas and strategic insights into future development, publications, and presentations.
  • Offer oversight and facilitate discussions on development strategies and risks.
  • Cross-functional communication, including with the board, regarding program strategies, risks, and progress.
  • Lead regulatory strategy and FDA engagement, including regular presentations to regulatory agencies.
  • Manage and mentor teams, ensuring alignment with strategic goals and timelines.
  • Collaborate with key departments, including biometrics, regulatory, clinical operations, and medical affairs, to ensure cohesive program execution.
  • Develop and manage program budgets, timelines, and deliverables, ensuring strategic alignment and financial oversight.
  • Represent clinical development programs at scientific conferences and in discussions with regulatory agencies and Key Opinion Leaders (KOLs).
Requirements:
  • MD (nephrologist preferred) with 12 years of experience in pharmaceutical or biotechnology clinical development, including at least 6 years in a leadership role.
  • Extensive experience in clinical development across all phases from preclinical through commercialization, including successful NDA/BLA submissions.
  • Strong leadership, negotiation, and communication skills, with experience engaging various stakeholders.
  • Proven ability to lead cross-functional teams in a global environment, including experience with FDA and international regulatory bodies.
  • Willingness to travel domestically and internationally as necessary.

This is an exceptional opportunity to make a tangible impact in the rare disease space with an innovative and mission-driven biopharmaceutical company. If you possess the qualifications and passion for rare disease therapeutics, Aura Biosearch invites you to apply for this key leadership position on behalf of our client.

Remote Work: No

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