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Medical Director

Job Post Index 21E49E-Sy##
Location Collegeville, PA
Description: Job Description
  • Leading designated aspects of the Medical Affairs strategic planning process and its implementation and in collaboration with their peers and other functions in the medical affairs team.
  • Plays an integral role in building/optimising the Integrated Evidence Plan (IEP) for the relevant asset/indication(s).
  • Drives delivery of designated above-country elements of the MAP, e.g. Advisory Boards, Symposia, Educational Events.
  • Partners with commercial colleagues to optimize brand strategy, campaigns and launches in the Franchise Local Operating Companies (LOCs).
  • Leading and overseeing partnerships from a GMA perspective for the relevant asset/indication(s).
  • Drives the development and/or approval of promotional, educational, training and other materials and responses.
  • Drives the congress planning and coordination from a brand perspective, including pre- and post-congress deliverables.
  • Drives the scientific training coordination and execution from a brand perspective, including material development and/or approval.
  • Delivers the evidence needs for that asset on behalf of the partnership with R&D.
  • Drives the efficient working of the Integrated Evidence Team, ensuring insights from Franchise LOCs are integrated appropriately to inform the IEP.
  • Reviews local company sponsored and Investigator Sponsored Study (ISS) proposals from Franchise LOCs to assess their scientific merit and strategic need, liaising with R&D experts.
  • Accountable for the development of assigned Franchise study protocols.
  • Drives excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
  • Gathers medical insights from the Franchise Local Operating Companies (LOCs) and external stakeholders (HCP’s, Patients, Payors and Regulators) to shape the integrated evidence strategy and global medical affairs plans and strategy.
  • Leads medical lead research activities including Expanded Access Programs.
  • Leads Advisory Board design and discussion ensuring compliance with SE governance and documentation requirements.
  • Leads Symposia and other Educational Activities design and discussion ensuring compliance with SE governance and documentation requirements.
  • Inputs to the design and delivery of phase IIIb/IV studies and EAPs, including post-approval commitments, coordinating with relevant R&D technical experts e.g. Global Health Organization and Epidemiology.
  • Responsible for the review of local company sponsored and Investigator Sponsored Study (ISS) proposals from Franchise LOCs to assess their scientific merit and strategic need, liaising with R&D, safety, biostats, and other experts.
  • Facilitates preparation for the aPIB review / Brand Planning processes, ensuring compliance with timelines and mandated global templates to ensure consistency across Franchises/Franchise LOCs.
  • Plays an integral role in the development and approval of brand strategy, and promotional campaigns and materials, ensuring compliance with all relevant codes and system requirements (ABPI, Zinc MAPs etc).
  • Develops/reviews publications/abstracts/posters related to the product, key competitors and relevant disease area(s).
  • Ensures the Data Dissemination Plan (DDP) is maintained.
  • Supports the in communicating effectively the clinical and market access data for their asset to the Franchise LOCs
  • Ensures a robust understanding of risk benefit.
  • Enhances local tactical plans and shares best practices to support Launch Excellence.
  • Providing medical governance oversight for the asset, including management of product related issues with potential impact on patient safety, and medical budget management.
  • Responsible for leading and overseeing partnerships from a GMA perspective for the relevant asset/indication(s).
  • Drives excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
  • High level of responsibility for successful delivery of critical projects and processes.
  • Responsible for building and driving the Global Medical Affairs strategy and IEP for the asset/indication(s)
  • Building credibility through the richness of her/his content expertise.
  • Responsible for successful delivery of Global Integrated Medical Affairs Plans (MAPs), Medical (Pre)Launch Plans, and Integrated Evidence Plans (IEP) for the relevant asset/indication(s) in accordance with company and statutory requirements.
  • Provides input into development plans.
  • Responsible for driving internal scientific training coordination and execution from an asset perspective, including material development and/or approval in accordance with company and statutory requirements.
  • Responsible for driving excellence in external engagement -building credibility with, and insights through, a strong external network.
  • Ensures appropriate medical governance including the management of product-related issues with potential impact on patient safety.
  • Responsible for driving the congress planning and coordination from a brand perspective, including pre- and post-congress deliverables.
Skills: Qualifications
  • Medical doctor board Certification (or equivalent credentials); OR
  • Extensive clinical and industry experience Oncology, PhD or PharmD.
  • Industry and/or clinical experience in the oncology therapeutic area.
  • Significant disease and therapeutic area knowledge.
  • Broad drug development experience with robust knowledge of GCP regulatory/ market access and reimbursement requirements.
  • Ability to develop, design and implement expanded access program studies.
  • Significant experience in Global Medical Affairs and life cycle management, including launch support requirements.
  • Robust understanding of promotional codes/regulations
  • Previous involvement in review and approval processes.
  • Highly developed leadership, networking, communication, inter cultural communication skills and influencing skills to work effectively in a complex matrix and global environment.
  • Demonstrated ability to build strong internal and external networks.

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