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!

About AstraZeneca

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.

Oncology Research & Development, 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. For us to be most effective, our Late Oncology team has 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 4 assets with studies in breast cancer. We currently have over 120 Phase 3 and Lifecycle Management Oncology projects in our robust pipeline.

What you’ll do

The Global Clinical Head – Gastrointestinal (GI) Cancer has the opportunity to make a difference in people’s lives every day. We are hiring in Cambridge (UK), New York City, and Washington D.C. area (Gaithersburg, MD).

This role defines and develops the clinical development plans in GI cancer 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 operation of a specific GI 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, BLAs, INDs, Safety and Annual reports, about complex clinical development issues (e.g., safety or efficacy).
• Work with functional management to develop plans and resolve issues
• The GCH will also have a meaningful role in working in the Alliance to help support the ongoing studies and also represent at key alliance forums including CDP-WG and JLT.
• 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

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 and managing 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
• 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

• Industry experience preferred
• Credible with Key External Oncology Stakeholders, Payers and oncology scientific communities
• Prior experience in managing patients with GI cancers and/or pharmaceutical R&D experience in GI malignancies is preferred but not required.

Why AstraZeneca

With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society.

So, what’s next

Ready to bring new ideas and fresh thinking to the table. Great! We have one seat available, and we hope it’s yours.

Where can I find out more

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

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Competitive salary and benefits package on offer

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.