Senior Director, Medical Affairs
Concentric Analgesics, Inc. is a private, biotechnology company focused on discovering and developing novel, non-opioid therapeutics for the management of acute and chronic pain. This position is based in San Francisco.
Reporting to the Chief Medical Officer, this position will lead the Medical Affairs function while serving as a key pathway for communication with leading hospital physicians and other healthcare providers as well as with academic and research institutions to support Concentric clinical and business interests. The position will assist in the coordination of clinical research activities and deliver clinical education efforts to clinical sites, collaborators and external partners, and assisting in translating the NDA documents into materials necessary to support launch activities. Working closely with other Concentric departments, this position will provide internal support on select clinical issues and advise on new opportunities to collaborate with key stakeholders and academic partners.
Key Roles & Responsibilities:
Design, develop, and implement educational events to build product awareness and advocacy, support and facilitate medical communications and publications (e.g. abstracts, case studies/series, review articles, etc.) Attend co-monitoring visits as required per the Sponsor Oversight Plan and/or Monitoring Plan
Assist in production of regulatory clinical documents and translating NDA documents into necessary launch materials.
Work directly with key opinion leaders in the development of CME programs and other scientific education activities while ensuring compliance with policies and standards
Organize clinical advisory boards and other scientific meetings with academic investigators, explore potential new indications, and procure input on the overall clinical development plan
Participate at numerous national and regional conferences, meetings and other scientific venues
Represent the company at key regulatory meetings including advisory committee meetings, as applicable
Working with the team developing the market access plan, support the publication strategy to ensure clear and consistent communication, and manage the publication and presentation timelines for conferences and medical publications
Close collaboration with Commercial, Legal, and Regulatory for development and review of external communications to verify adherence to current regulations and guidances
Monitor the competitive environment to sustain expertise in therapeutic area treatment management and new therapies, competitive products and features and provide feedback to the leadership team on specific initiatives
After the NDA filing, work with the commercial function to prepare launch plans and materials
Oversight of the medical science liaison team and medical information and support pharmacovigilance activities
Knowledge and Skill Requirements:
MD or the equivalent required (therapeutic experience in acute pain management preferred with demonstrated expertise in working in a hospital environment, but will consider other hospital-based specialties)
Demonstrated ability to excel in smaller entrepreneurial organizations.
At least 3 years (director level; 5 years for senior director level; or 10 years for VP level) of relevant experience in a medical affairs environment in the biopharmaceutical industry with demonstrated management and leadership abilities
Excellent oral and written communication skills and interpersonal skills (including strong demonstration of ability to network)
Ability to understand and effectively communicate scientific/medical and commercial components of drug products to the medical community and other key internal and external audiences.
Knowledge and understanding of hospitals as a distribution channel
Knowledge and understanding of clinical and regulatory guidelines, particularly GXP, and applicable regulations and statutes
Knowledge and understanding of compliance in commercial settings
Ability to travel up to 50%, attend regional and international conferences/workshops to obtain new competitive information, keep abreast of clinical trends, and support and maintain relationships with key investigators and scientific research.
Ability to respond appropriately to needs of key stakeholders and manage expectations
Demonstrate excellent project management skills and follow through
Must have excellent PC skills and be familiar with current clinical software and database tools
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