Medical Director - Oncology
Proclinical is currently recruiting for a Medical Director with a pharmaceutical company located in Collegeville, PA. Working independently, the Medical/Scientific Director is capable of fully leading designated aspects of the Medical Affairs strategic planning process and its implementation in collaboration with peers and other functions in the medical affairs team.
- Play an integral role in building/optimizing the Global Medical Affairs Plan (MAP) and Integrated Evidence Plan (IEP) for the relevant asset/indication(s)
- Drive delivery of designated above-country elements of the MAP, e.g. Advisory Boards, Symposia, Educational Events
- Partner 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)
- Drive the development and/or approval of promotional, educational, training and other materials and responses
- Drive the congress planning and coordination from a brand perspective, including pre- and post-congress deliverables
- Drive the scientific training coordination and execution from a brand perspective, including material development and/or approval
- Gather 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
- Lead medical research activities including Expanded Access Programs
- Lead Advisory Board design and discussion ensuring compliance with SE governance and documentation requirements
- Lead Symposia and other Educational Activities design and discussion ensuring compliance with SE governance and documentation requirements
- Input 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
- Facilitate preparation for the aPIB review / Brand Planning processes, ensuring compliance with timelines and mandated global templates to ensure consistency across Franchises/Franchise LOCs
- Play 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)
- Develop/review publications/abstracts/posters related to the product, key competitors and relevant disease area(s). Ensures the Data Dissemination Plan (DDP) is maintained
- Support the GMAL in communicating effectively the clinical and market access data for their asset to the Franchise LOCs; ensures a robust understanding of risk: benefit
- Enhance local tactical plans and shares best practices to support Launch Excellence
- Support the GMAL in 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)
- Drive excellence in Scientific Engagement (SE) with key stakeholders (HCPs, Patients, Payors and Regulators) to gain a deep understanding of customer needs.
Skills and Requirements:
- 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, intercultural communication skills and influencing skills to work effectively in a complex matrix and global environment
- Demonstrated ability to build strong internal and external networks
- Ability to work across time zones and to travel
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.