Senior Medical Director/Global Clinical Lead, Immuno-Oncology - Gaithersburg, MD | Biospace
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Senior Medical Director/Global Clinical Lead, Immuno-Oncology

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
8/24/2017
Position Type:
Full time
Job Code:
R-008826
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: Gaithersburg,
Maryland,
United States
Cambridge,
Massachusetts,
United States
Job reference: R-008826

Posted date: Jul. 24, 2017



Location:
Gaithersburg, Maryland, United States or
Cambridge, United Kingdom

Job reference:
R-008826

Posted date:
Jun. 09, 2017

Closing date: Oct 07, 2017

Salary: Competitive

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity, even in the most difficult situations because we are committed to doing the right thing.

This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our portfolio means we have a late stage pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines. In Global Medicines Development (GMD) we have a crucial role to play. Faced with complex disease challenges, we’re focused on exceptional performance to drive the best and most transformative drug programmes ever.

We believe that combination strategies may unlock the potential of IO therapies to redefine the cancer treatment paradigm. AstraZeneca is a leader in IO combination therapy, with a pipeline focused on exploring the potential of immuno-oncology combinations.

Your major Accountabilities and Responsibilities:

Portfolio

You will take overall clinical, scientific & value content for an assigned portion of the Program, as well as support the CPT lead in rapidly implementing new processes and systems and sharing/seeking learning through your portfolio of projects and have medical prioritisation of clinical activities, too. You will be the 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 and become a core member of Clinical Product Team (CPT).

In the role, you will assume leadership of the Design and Interpretation Working Group (DIWG) and ensure internal and external peer review of potential study/program design whilst providing clinical strategic input to in-licensing opportunities.

In this broad leadership role across the Business, you will be required to support as appropriate within the Program during issue and crisis management as directed by the Vice President, Clinical for Immuno-Oncology.

Global Product Team

You will provide timely Medical Scientific strategies for clinical components of the TPP, TPC, CDP, and core labelling texts and be responsible for medical input into commercial activities as well as efficiently provide scientific component of the pricing & value strategy.

You will have accountability for the execution of the integrated product plan to agreed scope, timelines, and resources/budget, and ensure that PDT outputs are cross-functionally integrated, of high quality, and strategically aligned. You will also lead/represent the PDT at governance meetings, including internal and external stakeholder management. The role requires you to lead the PDT to effectively manage/mitigate/communicate risk, make decisions, and manage conflict and change.

You are responsible for maintaining a high degree of PDT effectiveness through collaboration, influence, and, as necessary, coaching and mentoring of team members and alliance management accountabilities and responsibilities generally consistent with the foregoing. You will be responsible for the ethical and scientific integrity of the plans, studies and the product and the risk management plan of the Program, together with Patient Safety.

You will have high level strategic internal and external interactions including Academic collaborations and Key Opinion Leader & key centres development and support as well as support rapid implementation of new processes & systems through their Program, together with Project Coordination Director. You’ll need to ensure the Program clinical strategies and plans receive peer review to assure quality and support as appropriate within the Program during issue & crisis management, as directed by the Immuno-Oncology Clinical Vice President.

You will represent the Company at meetings with Regulatory Agencies and Governmental bodies, with external scientific fora, clinical investigators and other clinical personnel and be a medical representative at internal governance groups i.e. HELC, TAPT, PRB. You will also provide medical input into commercial activities and scientific component of the pricing & value strategy.

Clinical Project Team

You will have overall responsibility for the clinical strategy to meet development decision points/TPP/TPC and target labelling and make clinical contributions to Regulatory and Governance documents, i.e. MS4C, HELC, IB, IND. You will have high level strategic external interactions including academic collaborations, key opinion leaders & key centres development and support. You will also be responsible for delivery of Medical Science components to the Program to time and quality and the Risk Management Plan, Periodic Safety Updates, SaMT and SERM, together with Patient Safety.

You will also ensure the Program clinical strategies and plans receive peer review to assure quality and coach Study Team Physicians working on their Projects.

Requirements

Essential requirements

  • You will be a 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 Immuno-Oncology, Tumor Immunology, or Immunotherapy.
  • Specialty training or board eligibility in Medical/ Pediatric Oncology or Hematology.
  • 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.
  • Orchestrate and drive the value demonstration team.
  • 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).

    Additional Desired Requirements

  • Named Investigator on a number of clinical trials.
  • Progressed compounds into FTIM and delivered PoP.
  • Significant and consistent peer-reviewed publication track record.

    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.