Global Clinical Head - Breast Cancer
At AstraZeneca, we are committed to advancing the science of oncology to deliver life-changing medicines to patients most in need. For us to be most effective, our Late Oncology team is focused on four key disease areas; Lung Cancer, Breast Cancer, GU/GYN Cancer, and GI Cancer. The Late Development Oncology team is comprised of almost 900 team members across clinical development and clinical operations. We have 12 assets in late development with multiple assets investigated in studies in breast cancer. We currently have over 120 studies most of them Phase 3.
As the Global Clinical Head - Breast Cancer (focused on Capivasertib and Oral SERD) you’ll have the opportunity to make a difference in people’s lives every day. The role is available in New York City, Washington D.C. area (Gaithersburg, MD) and Cambridge, UK.
This role defines and develops the clinical plans in Breast cancer, with main focus in HR+ subgroup, for Capivasertib and Oral SERD and ensures scientific value creation across lifecycle including initial approval, launch, lifecycle indications through to patent expiry.
- Delivery of the product Target Product Profile (TPP) and Target Product Claims (TPC) and maintenance of the Integrated Product Development Plan (iPDP)
- Full responsibility for the planning, implementation and daily operation of the breast cancer Capivasertib and Oral SERD 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 rigorous 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 various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, about complex clinical development issues (e.g., safety or efficacy).
- Work with functional management to develop the plans and resolve issues
- Deliver product information to support internal and external business portfolio reporting (eg. R&D head, CEO briefings, annual results communications etc).
- Contribution to develop all external information on the product (including publications, regulatory documents, clinical trial registers etc)
Essential for the role
- Qualified Physician (M.D. degree or equivalent), Medical specialty and sub-specialty training and certification required in Oncology
- Clinical experience in treating Breast Cancer patients
- Clinical drug development experience in academic institution or biopharma industry
- Deep oncology expertise. Fully conversant with science as it relates to the brand
- Business Acumen - 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
Desirable for the role
- 10+ years of industry and/or clinical experience preferred
- Credible with Key External Oncology Experts, Payers and oncology scientific communities
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.