Global Clinical Lead, Oncology
Location: Cambridge, United Kingdom
Salary: We offer a competitive salary and benefits package.
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 exceptional skills with those of people from all over the globe. As a Global Clinical Lead Oncology you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
AstraZeneca’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
AstraZeneca leverages strength and expertise in Oncology Science, where research efforts are focused on gaining a better understanding of the common biology and shared molecular pathways among inflammatory and autoimmune diseases, as well as the fundamental drivers and mechanisms of disease. This approach enables us to identify and select drug targets that have the potential to effectively treat not just one, but multiple inflammatory and autoimmune diseases.
Main Duties and Responsibilities
The Global Clinical Lead (GCL) will have overall clinical leadership of one or more global teams and will deliver 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), , Clinical Development Plan (CDP), and core labelling texts and will provide medical input into commercial activities and the scientific component of the pricing and value strategy. Within the Clinical Project Team, the GCL has accountability for the clinical, scientific and value content and delivery of the Medical Science components for the Program to time and quality. GCL will also hold line management accountability for the physicians and clinical scientists working on their team and this includes mentoring and career development. GCL will be the team’s voice and representative at the Global Product team that is in charge of the overall strategy of Oncology
Overall clinical, scientific & value content for an assigned portion of the Program. Support the CPT lead in rapidly implementing new processes and systems and sharing/seeking learning through their Portfolio of Projects. Medical prioritization of clinical activities within their Portfolio of Projects. 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 Theraspeutic Area Head for the Oncology GMed. Global Product Team; Timely provision of Medical Scientific strategies for clinical components of the TPP, CDP, and core labelling texts. Medical input into commercial activities. Timely provision of scientific component of the pricing & value strategy.
- Graduate of a recognized school of medicine with an M.D. degree or equivalent.
- Demonstrated clinical research expertise in Oncology with a preference for direct expertise in Oncology
- Experience in Phase 3 program development and trial conduct, as well as NDA/BLA submissions strongly desired
- Specialty training or board eligibility in Medical/ Pediatric Oncology or Hematology, 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.
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