Global Clinical Head-Cell Therapy

Overview

Do you have deep Oncology expertise in clinical drug development and a passion for cell therapy? In this role, you can apply your skills to impact the way cancer is treated and make a meaningful difference to patients!

About Astra Zeneca

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society.

Cell Therapy, Late Development Oncology

At AstraZeneca, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. The Cell Therapy, Solid tumor team drives the clinical development of novel cell therapy assets. This team sits in the Late Development Oncology unit, a team comprised of almost 900 team members across clinical development and clinical operations.

The Global Clinical Head has the chance to define a difference in people’s lives every day.

In this position you will define and develop the clinical development plans for one or more cell therapy products and ensures scientific value creation across lifecycle including proof of concept studies, initial approval, launch, and lifecycle management.

• 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 within a Global Product Team (GPT). Ensure delivery as a core member of the GPT team by providing overall clinical leadership of the asset.
• Full responsibility for the planning, implementation and operation of the product's drug development projects, including responsibility to:

• 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
• 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.

• Qualified Physician (M.D. degree or international equivalent)
• Oncology clinical drug development experience in academic institution or biopharma industry (Minimum 7 years of experience)
• Cell therapy expertise
• 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

• MD, PHD
• Industry experience preferred
• Medical specialty and sub-specialty training and certification in Oncology or Hematology preferred
• Clinical experience in treating and managing Cancer patients…