Global Clinical Lead - Oncology - Gaithersburg, MD | Biospace
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Global Clinical Lead - Oncology

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
8/18/2017
Position Type:
Full time
Job Code:
R-011807
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: Cambridge,
England,
United Kingdom
Gaithersburg,
Maryland,
United States
Job reference: R-011807

Posted date: Aug. 01, 2017



Global Clinical Lead, Oncology

Location: Gaithersburg, US or San Francisco US or Cambridge, UK

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.

Requirements

Essential Requirements:

  • 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 juniorphysicians/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.

  • Ability to travel nationally and internationally.

  • Experience in several organizations and geographic locations.

  • 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 PoP.

  • Significant andconsistent peer-reviewed
    publication track record.

Next Steps – Apply today!

Posting Date: 1st August 2017

Closing Date: 15th Dec 2017

Salary: Competitive plus comprehensive benefits package

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.