Medical Director/Sr. Medical Director, Medical Affairs
Wilmington, DE, USA | Incyte Corporation
Industry:Pharmaceutical / Biotech
Job Description:99 people have viewed this job
Job Summary(Primary function)
The physician in this business-critical position contributes to the strategy and execution of Medical Affairs activities supporting the company's new product/compounds in late-stage development in Oncology, as they transition to Medical Affairs. This individual will actively contribute to all aspects of new product support and plays a critical role in promoting and maintaining professional relationships with key medical experts in the field of Oncology. They are additionally responsible for medical monitoring of Medical Affairs led clinical and translational studies of new products, managing independent investigator-initiated trials (IIT) programs and select external translational research collaborations.
Essential Functions of the Job(Key responsibilities)
Supports the planning and drives the execution of various Medical Affairs projects. Therapeutic areas include but not limited to immune-oncology. Following responsibilities:
Provides strategic input and day-to-day advice on Medical Affairs plans and contributes to cross-functional strategies from the scientific and medical affairs perspective.
Provides medical and scientific expertise to core business strategy and marketing plans.
Contributes to annual and long-term strategic and tactical planning and execution of Medical Affairs plans.
Potential for Leadership of a therapeutic area / asset-based teams, empowering others while driving the execution of deliverables with the appropriate timeliness, quality, compliance, and use of resources.
Member of several internal cross-functional teams, providing scientific and clinical advice and input.
Participates in the review/approval process of promotional and educational materials (copy review via the Medical, Legal, Regulatory team), as well as materials and data communications used in medical and scientific exchange for as appropriate. Provides medical support for all appropriate initiatives relevant to future Market Access, including presentations to payer groups, pharmacy and therapeutics committees, and other similar external stakeholders, especially in a pre-launch setting, as appropriate.
Provides medical support for all appropriate initiatives relevant to Market Research & Analytics.
Provides medical support for all appropriate initiatives relevant to Sales Force Education on new products, especially in the pre-launch setting, as appropriate.
Drafts, reviews, presents and discusses scientific and medical content on new products across a broad range of internal communications and document streams including: Medical Information Service response letters and slide sets, medical science liaison training material, advisory board presentations, technical dossiers, internal monographs, etc.
Provides input in the design of health outcome (HEOR) studies, as well as company-sponsored clinical (phase I-IV) and translational (e.g., molecular pathology or molecular analysis or other correlatives) studies, and contributes to their timely completion and delivery of corresponding data.
Provides input to product labeling discussions, including label enhancements/updates.
Participates in the review and approval of investigator-initiated trials (IITs) and other external research grant requests.
Participates in the Independent/Continuous Medical Education (IME/CME) Grant review process as relevant to new products.
Fulfills appropriate requests for scientific & medical data presentations, as well as supports customer visits for scientific data exchanges on the company’s pipeline in coordination with territory MSLs, Medical Affairs leadership, and Drug Development and/or Discovery/Biology colleagues.
Provides medical/scientific training for internal Medical Affairs personnel on new products and disease state aspects, in collaboration with the MSL training director.
Participates actively in the training on company new product data of select external collaborators and scientific personnel of engaged support agencies.
Establishes and maintains appropriate professional relationships with external key medical experts, researchers and academic institutions within each pertinent medical/scientific community with focus on new products including the following:
Plays a proactive and independent role in the initiation, nurturing and sustenance of interactions with external stakeholders on a long-term basis and in a customer-centric manner.
Identifies and appropriately interacts with advisors and substantively contributes to the planning/facilitation of scientific Advisory Boards.
Proactively stay informed on current scientific developments through familiarity with relevant recent literature, regular attendance of major Oncology and other medical society.
Possesses an up-to-date knowledge base for assigned projects and products, including competitive landscape.
Qualifications (Minimal acceptable level of education, work experience, and competency)
The ideal candidate for this role should have:
M.D. degree or equivalent.
Clinical care and research experience in use of immune-oncology drugs in oncology, preferred.
Minimum of five (5) years post Medical Degree experience, of which at least three (3) years are within the Pharmaceutical or Biotech Industry working in Medical Affairs and/or Clinical Research & Development departments, preferably working on Hematology or Oncology products. Will consider candidates with academic experience developing clinical trials in the immune-oncology space.
US-based experience preferred.
Product launch experience preferred.
Understanding of the clinical trials and FDA approval processes.
Knowledge and understanding of US regulatory rules landscape (pertinent FDA Guidance for Industry), as well as Office of Inspector General and Dept. of Justice statutes and regulations; overall appreciation of the compliance landscape.
Strong business acumen, vision and perspective.
Ability to build and lead teams with or without management authority, empowering others while ensuring the quality of deliverables.
Ability to comprehend and combine complex sets of data, spanning multiple projects and products/agents.
Ability to handle multiple demands in a fast-paced environment and to interact within the context of multidisciplinary teams.
Excellent written and oral communication; superior presentation skills; strong analytical ability.
Ability to interact and communicate with the highest degree of professionalism and scientific credibility with external scientific leaders (academic, government, consortia, laboratory chiefs in major institutions, etc.).
A high level of initiative and independence.
Travel will be required, estimated at approx. 30%. The vast majority of this travel activity will be within the US. Travel will include major national and international conferences, advisory boards, interaction with scientific leaders and organizations, as well as annual national company meetings and departmental training sessions and retreats
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