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:
6/25/2017
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: Jun. 09, 2017



Major Accountabilities and Responsibilities:

Accountabilities

Portfolio

  • 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 prioritisation 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.
  • Core member of Clinical Product Team (CPT).
  • Leadership of the Design and Interpretation Working Group (DIWG).
  • 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 Vice President, Clinical for Immuno-Oncology.

Global Product Team

  • Timely provision of Medical Scientific strategies for clinical components of the TPP, TPC, CDP, and core labelling texts.
  • Medical input into commercial activities.
  • Timely provision of scientific component of the pricing & value strategy.

Responsibilities

Global Product Team

  • Have accountability for the execution of the integrated product plan to agreed scope, timelines, and resources/budget,
  • Have accountability for ensuring that PDT outputs are cross-functionally integrated, of high quality, and strategically aligned.
  • Lead / represent the PDT at governance meetings, including internal and external stakeholder management.
  • Lead the PDT to effectively manage./mitigate/communicate risk, make decisions, and manage conflict and change.
  • Have responsibility 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.
  • The ethical and scientific integrity of the plans, studies and the product.
  • The risk management plan of the Program, together with Patient Safety.
  • High level strategic internal and external interactions including Academic collaborations and Key Opinion Leader & key centres development and support.
  • Support rapid implementation of new processes & systems through their Program, together with Project Coordination Director.
  • Ensure the Program clinical strategies and plans receive peer review to assure quality.
  • Support as appropriate within the Program during issue & crisis management, as directed by the Immuno-Oncology Clinical Vice President.
  • Represent the Company at meetings with Regulatory Agencies and Governmental bodies.
  • Represent the Company at meetings with external scientific fora, clinical investigators and other clinical personnel.
  • Medical representation at internal governance groups i.e. HELC, TAPT, PRB.
  • Medical input into commercial activities.
  • Timely provision of scientific component of the pricing & value strategy.

Clinical Project Team

  • Clinical strategy to meet development decision points/TPP/TPC and target labeling.
  • Clinical contribution to Regulatory and Governance documents, i.e. MS4C, HELC, IB, IND.
  • High level strategic external interactions including academic collaborations, key opinion leaders & key centres development and support.
  • Delivery of Medical Science components to the Program to time and quality.
  • The Risk Management Plan, Periodic Safety Updates, SaMT and SERM, together with Patient Safety.
  • Ensure the Program clinical strategies and plans receive peer review to assure quality.
  • Coach Study Team Physicians working on their Projects.

Requirements

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 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.