Director, Medical Affairs

Main Responsibilities, Activities, Duties and Tasks

• Provide medical oversight, and assist and support management, of the BED IIT program
• Provide USMA representation and support across multiple company sponsored clinical trials / global development programs, including assisting and advising on investigator and site selection, liaising with KOLs/investigators, assisting with insight generation as required to support these initiatives.
• Participate in strategic planning in a multidisciplinary setting involving clinical development, R&D, regulatory affairs, and commercial functions.
• Provide medical oversight of the Medical Information function and serve as the first medical escalation point for unsolicited requests for medical information, ensuring responses are scientifically accurate, balanced, compliant, and aligned with applicable regulations and company policies.
• Serve as a member of the USMA – Oncology leadership team, and drive USMA programs/initiatives as assigned by the VP of USMA – Oncology
• Collaborate in training sales representatives and USMA field personnel in the principles and practices of disease management for targeted clinical areas and on the attributes and clinical data regarding BED marketed products and products in development.
• Lead the planning, execution, and scientific oversight of advisory boards, ensuring the collection of high-quality external expert insights to inform medical strategy, evidence generation, and patient care initiatives.
• Establish and maintain relationships with national/international Key Opinion Leaders in US and within targeted therapy areas in conjunction with Medical Science Liaisons (MSLs) across the country.
• Provide medical input into the development of field team tools and resources.
• Stay current in targeted therapy areas and with current and future competition (on market and in development).
• Proactively maintain communications with other BED Medical Affairs & Clinical Development staff within the global team as needed to advance related initiatives.
• Perform any other duties as requested by the VP USMA – Oncology and/or the senior leadership team, ensuring the smooth operation and growth of the business.

Qualifications

• Advanced scientific or clinical degree (MD, PharmD, PhD, PA, NP, MSc or equivalent)
• Minimum of five (5) years relevant work experience, of which at least three (3) years are within the Pharmaceutical or Biotech Industry working in Medical Affairs and/or Research & Development departments, preferably working in diagnostic nuclear medicine.
• 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 and product marketing acumen, vision and perspective.
• Ability to comprehend and combine complex sets of data, spanning multiple projects and products.
• 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%.
• Qualified candidate must be legally authorized to be employed in the United States.
• Excellent oral & written communication skills.
• Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
• Strong coaching, facilitation, and organizational skills; team player.
• Experience and skills with cross-functional and highly matrixed organizations.