The Sr Medical Director represents a key role of all aspects related with Medical Affairs responsibilities for a particular brand(s). Responsible to ensure strategic and cross-functional alignment to achieve the medical mission of supporting safe and appropriate use of a particular brand. With responsibilities in Medical Communications, Safety, Clinical trials, etc. Reporting to the Medical Unit Head or TA head (VP or AVP), this position will occupy a key leadership role for one or more of the company's products.
• Leadership role within a cross-functional team of medical professionals (health outcomes, biostatistics, clinical operations, medical communications, safety, regulatory, and field liaisons) in planning and execution of all aspects of medical affairs product support. Lead creation of the Medical Plan Strategy and execution of tactics. Responsible for creating strategies for an extensive US clinical trials program. Provide medical leadership into the product marketing strategies. Develop Medical Communication strategy and ensure its operational execution (Abstracts, publications, slide decks, oral presentations, etc.). Identify and communicate Product Alerts to the Core Team (in conjunction with U.S. Drug Safety, USRAMP, GMA). Responsible for assessing Core Team Members competencies and participation. Lead the review and approval of IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOP(s) and develop a broad data generation plan/ strategy, including IST’s.
• Review, approve and supervise all aspects of US phase IIIB - IV clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, and clinical trial guidelines. Oversee conduct of all clinical studies in adherence to both Company standards, and government/industry regulations (GCP/ICH). Ensure final accuracy of clinical trials data and its timely availability (Clinical Study Report), in appropriate format and works closely with Regulatory in developing plans for IND and/or sNDA submissions.
• Support and execute operational and tactical activities from the Medical Communication Plan as needed (publications, abstracts, etc.). Medical review and approval of promotional material (including concepts) in compliance with corporate standards and government/industry regulations.
• Prepare a strategy for Independent Medical Education and execute the operational/ tactical elements of the medical education processes (CME grants). Provide medical review and approval of regulatory documents pertaining to the work of the medical team.
• Partner with U.S. Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals. Provide medical input to the product labeling, as needed. Provide professional medical expertise to Sales, Marketing and Legal functions on marketed products and drugs currently in approval process.
• Assure alignment of initiatives across any existing Joint Ventures, including design and execution of all strategies and programs. Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) within pertinent medical community. Fosters the establishment and maintenance of external scientific advisory boards and assists in advocacy development (in conjunction with RML). Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc. Maintain clinical and specialty expertise. Attend business team meetings, advisory board meetings, steering committee meetings. Demonstrate required Competencies on consistent basis. Demonstrate company Values on consistent basis.
• Work in close collaboration with field medical team to support field medical work and collect medical insights from the field. Collaborate with R&D, market access, and business development support as required. Support/ execute appropriate pre-launch and launch activities. Support the label development and updates as appropriate.