Medical Director of Oncology/Hematology
Proclinical is currently recruiting for a Medical Director of Oncology/Hematology for a pharmaceutical company located in Philadelphia, PA. Successful candidate will lead designated aspects of the Medical Affairs strategic planning process and its implementation on behalf of the Global Medical Affairs Leader and in collaboration with her/his peers and other functions in the medical affairs team.
- Gather medical insights from the Franchise Local Operating Companies and external stakeholders to shape the integrated evidence strategy and global medical affairs plans and strategy.
- Lead Advisory Board 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, coordinate with relevant R&D technical experts.
- Responsible for the review of local industry-sponsored and Investigator Sponsored Study (ISS) proposals from Franchise LOCs to assess their scientific merit and strategic need, liaise with R&D, safety, biostats, and other experts.
- Facilitate preparation for the aPIB review/Brand Planning processes, ensure 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, ensure compliance with all relevant codes and system requirements.
- Develop/review publications/abstracts/posters related to the product, key competitors and relevant disease area(s). Ensure the Data Dissemination Plan (DDP) is maintained.
- Enhance local tactical plans and share best practices to support Launch Excellence.
- 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.
- High level of responsibility for successful delivery of critical projects and processes.
- 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 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 statutory requirements
Skills and Requirements:
- MD required.
- 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 Phase IIIb/IV 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.
- Extensive clinical and industry experience - Multiple Myeloma, Hematology/Oncology, Oncology.
- Capability to build strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit.
- Managing P&L and capital allocation.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.