Global Clinical Head-Cell Therapy

AstraZeneca•Waltham, MA

About The Position

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 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. 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. What you’ll do: 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:

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)
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

Nice To Haves

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 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
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

The annual base pay for this position ranges from 323,216.00 - 484,824.00 USD Annual.
Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours.
Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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