Director, Medical Information / Scientific Communications

The Director, Medical Information / Scientific Communications is responsible for the oversight of the scientific communications team within Medical Affairs at Replimune.

Responsibilities

Supporting the entire Medical Information services in preparation for the launch and continued medical support needed for Replimune marketed and pipeline products; Oversees the medical information strategy including timely development and updating of standard response letters (SRLs) and frequently asked questions (FAQs) documents utilized to respond to unsolicited medical information queries; Ensures that the Medical Information database is accurate and up to date; plans and implements upgrades and enhancements as required; Oversight of the Call Center Training for Disease State and Product Pivotal Data as well as Work Instructions and Handling Guides necessary to insure complaint and fair balanced Medical Inquiry responses for Replimune Products; Provides clinical guidance to assist the resolution of escalated medical and/or access inquiries from the call center; Contribute to the scientific/medical review of all promotional and scientific materials through the Medical Legal Review (MLR) committee; Oversees the development of field medical and relevant market access resources for establishing and implementing and scientific communication initiatives; Oversees submissions to drug compendia (NCCN, etc) in collaboration with a cross-functional strategic partners; Develops the strategic direction, leads, and manages the day-to-day activities of the Medical Information, hiring and mentoring staff members as appropriate; Interfaces with senior levels across multiple cross-functional teams including pharmacovigilance, quality, medical directors/leads, field medical teams, commercial, regulatory, legal, and clinical development as well as external partners and serves as a medical information expert; Drive business optimization and Medical Information vendor management to ensure high quality service delivery and operational efficiency; Providing oversight and support for scientific conferences with medical information activities; Ensures the development and update of medical information department policy guidelines and SOPs

Requirements

Advanced degree in the sciences required (MD/PhD/PharmD); 5+ years of pharmaceutical or biotechnology industry experience, with a minimum of 3 years of experience in Medical Information or Medical Communications is required; Clear understanding of internal/external regulatory and ethical guidelines relevant to the pharmaceutical industry; Comprehensive knowledge of the drug development process, medical affairs, patient safety, and commercial activities; Proven ability to interpret, communicate and implement medical/scientific strategies using systems, tools and processes (e.g., Veeva Vault, CRM, etc); Strong leadership with a proven ability to generate credibility both internally in a multicultural organization and externally, driving consistent results and fostering collaborative relationships to enhance organizational performance; Ability to efficiently manage time and priorities; Ability to cultivate and maintain relationships with thought leaders and to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through to requests from thought-leaders; the ability to work effectively with key decision makers, both within and outside the Company; Excellent communicator, skilled at diplomacy and capable of effectively combining science and relationship building; Ability to understand and translate external customer and/or internal client needs into effective decisions and to drive results and strive for continuous improvement with high performance in the face of adversity a must; Willingness to travel

Nice to have

Team building experience (with direct reports)

Benefits

annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical, dental, and vision insurance; 401k match; flexible time off; paid holidays including year-end shutdown