VP, Clinical Development, Amyloidosis and Rare Cardiology

Responsibilities

• Provide visionary leadership for global clinical development and design strategic development plans for the Amyloidosis & Rare Cardiology franchise.
• Oversee the execution of clinical trial protocols, ensuring studies are delivered on time, within budget, and in compliance with GCP and GMP.
• Lead cross-functional R&D input for Business Development opportunities, including technical due diligence assessments.
• Coordinate with Regulatory Affairs to integrate sound practices into preclinical, clinical, and post-marketing activities.
• Manage the global project team and review development plans through the entire product lifecycle.
• Represent the company as a senior medical spokesperson before scientific, medical, and regulatory professional meetings.
• Cultivate relationships with key opinion leaders and medical experts within the academic community.

Requirements

• M.D. with a specialty in Cardiology is preferred; Ph.D. or PharmD with cardiology expertise will be considered.
• 10+ years of extensive industry experience in drug development, registration, and approval.
• Proven experience leading at least one candidate through the development process and playing a lead role in IND/IMPD and BLA/NDA/MAA filings.
• Demonstrated experience participating in FDA, EMA, or PMDA meetings (e.g., Pre-IND, Advisory Committees).
• Strong knowledge of regulatory requirements, GCP, GMP, and clinical protocol review.
• Deep understanding of CMC, pharmacology, toxicology, and PK as they relate to major regulatory filings.
• Exceptional leadership skills with experience managing multidisciplinary programs in a matrixed, global organization.

About the Company

AstraZeneca is a global, science-led biopharmaceutical company that focuses on discovering, developing, and commercializing prescription medicines. Through its work in areas like Alexion, the company strives to deliver life-changing medicines that transform patient care in rare diseases and complex therapeutic areas.