Global Clinical Lead, Late Oncology, GU Cancers

Astrazeneca Gaithersburg , MD 20877

Posted 3 months ago

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's outstanding skills with those of people from all over the globe.

Our ambition is to push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. To accomplish this, we focus on research and development and our commercial capabilities to deliver a new generation of medicines that have the potential to redefine cancer treatment.

As a Global Clinical Lead (GCL) in Oncology you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. The 'Late Oncology' department drives late-stage development of our innovative Oncology pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

Within our Late Oncology team at AstraZeneca, we are actively seeking a Global Clinical Lead to specifically focus on an Immuno-Oncology (IO) product for GU cancers. In this role, you will lead the design, delivery and interpretation of clinical studies for an assigned portion of the program, ensuring ethical and scientific integrity.

Main Duties and Responsibilities

As the GCL for a late IO product focused on GU cancers, you will have overall clinical leadership of one or more global clinical project teams (CPT). Additionally, you will deliver the Clinical Development Plan (CDP) for a portion of the Oncology pipeline (herein referred to as the "Program"), the Medical Scientific strategies for clinical components of the Target Product Profile (TPP), and core labelling texts and will provide medical input into commercial activities and the scientific component of the pricing and value strategy.

In this role, you will oversee the overall clinical, scientific & value content for an assigned portion of the Program. Additional responsibilities include:

  • Overall clinical, scientific & value content for an assigned portion of the Program.

  • Support the Clinical Project Team leading in rapidly implementing new processes and systems and sharing/seeking learning through their Portfolio of Projects.

  • Medical prioritization of clinical activities.

  • Single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and products in compliance with GCP.

  • Ensure internal and external peer review of potential study/program design. As available, provide clinical strategic input to in-licensing opportunities.

  • Broad leadership role across the business.

  • Support as appropriate within the Program during issue and crisis management as directed by the Therapeutic Area Head for Immuno-Oncology.

Essential Requirements:

  • Graduate of a recognized school of medicine with an M.D. degree or equivalent.

  • Demonstrated clinical research expertise in Oncology.

  • Experience in Phase 3 program development and trial conduct, as well as NDA/BLA submissions strongly desired.

  • Demonstrated ability to lead the development of project strategy and be accountable for project plans, timelines, progress, and outcomes.

  • Demonstrated ability leading and motivating teams in a matrix environment.

  • Demonstrated ability to lead, coach, and mentor junior physicians/scientists.

  • Significant hands-on clinical drug development experience and scientific credibility.

  • Experience of Clinical/commercial interface.

  • Benefit/risk assessment and creating PRMP/ BRATs.

  • Global regulatory submissions and interacting with major Health Authorities.

  • Developed/delivered in parallel, composed of multiple complex and large studies (e.g., including but not limited to multinational outcome studies).

  • Demonstrated ability to cultivate excellent cross-functional collaborations.

  • Demonstrated ability to effectively communicate at multiple levels of the organization.

  • Must demonstrate high integrity.

  • Organize and deliver Advisory Boards with international Key Opinion Leaders (KOLs).

Desirable Requirements:

  • Named Investigator on a number of clinical trials.

  • Progressed compounds into FTIM and delivered Proof of Principle.

  • Significant and consistent peer-reviewed publication track record.

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