Global Clinical Head- Late Development Oncology

AstraZeneca • Gaithersburg, MD

122d • $323,216 - $484,824

About The Position

Do you have deep Oncology expertise in clinical drug development and passion for leading late phase clinical program strategies? In this role, you can apply your skills to impact the way cancer is treated, and make a meaningful difference to patients! The Global Clinical Head has the chance to define a difference in people's lives every day. In this position define and develop the clinical development plans for a product and ensures scientific value creation across lifecycle including initial approval, launch, lifecycle indications through to patent expiry. This role is externally facing leadership role. Delivery of the product Target Product Profile (TPP) and Target Product Claims (TPC) and maintenance of the Integrated Product Development Plan (iPDP). Manage and develop a team of Global Development Medical Directors and Scientist Directors within a Global Product Team (GPT). Ensure delivery as a core member of the GPT team by providing overall clinical leadership of the asset.

Requirements

• Qualified Physician (M.D. degree or international equivalent)
• Oncology clinical drug development experience in academic institution or biopharma industry (Minimum 7 years of experience)
• Deep oncology expertise.
• Fully conversant with science as it relates to the brand
• Understands unmet market needs, creates a clear path forward, shows how to win
• Robust knowledge of and evidence of successful oncology product development based on strong science, commercial insights, market research and competitive intelligence
• Demonstrated understanding of oncology patient selection and stratification including companion/complementary diagnostic development and registration
• Ability to provide clinical leadership for an asset to multiple stakeholders through clear communication and strategic thinking

Nice To Haves

• Industry experience preferred
• Medical specialty and sub-specialty training and certification in Oncology preferred
• Clinical experience in treating and managing Cancer patients preferred
• Credible with Key External Oncology Stakeholders, Payers and oncology scientific communities

Responsibilities

• Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment.
• Design scientifically meticulous and cost-effective clinical protocols that are aligned with the clinical development plan.
• Present and defend protocols and clinical development plans at internal governance forums.
• Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team.
• Present study updates, interim results, and final headline data to senior management as required.
• Lead preparation of documents for Regulatory and other agencies, such as Dossiers, NDA, BLAs, INDs, Safety and Annual reports, about complex clinical development issues (e.g., safety or efficacy).
• Identify and assess clinical opportunities for the asset.
• Work with functional management to develop plans and resolve issues.
• Deliver product information to support internal and external business portfolio reporting (eg. CEO briefings, annual results communications etc).
• Develop all external information on the product (including publications, regulatory documents, clinical trial registers etc).
• Manage and protect the Intellectual Property (IP) assets of the product in consultation with IP and legal specialists including leadership of the Patent, Regulatory and Legal Defense Team.

Benefits

• 401(k) plan
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Master's degree