The Senior Director of Medical Affairs Bile Acid Disorders will lead all Medical Affairs activities for the Retrophin’s Bile Acid products under the supervision of the Executive Director, Medical Affairs Rare Disease. The ideal candidate will have experience and a proven track record of success in the biotechnology or pharmaceutical industry with a strong background in Medical Affairs and Bile Acid Disorders. This experience should include developing strong working relationships with key thought leaders, medical communications and support of colleagues in internal departmental functions. This candidate will thrive in a dynamic and fast-paced team environment, be well-organized and able to develop project strategies and execute project details.
• Act as liaison between staffing and senior management, establish goals for specific projects, offer guidance and provide clinical and medical guidance and strategy for Medical Affairs.
• Provide clinical input and protocol development for Phase III programs within designated therapeutic areas.
• Work closely on collaborative projects with medical affairs and other department for planning and execution of medical affairs studies, conference planning, advisory boards, publication planning, field force training, review of standard response letters, HECOR analysis and marketing initiatives.
• Close collaboration with the Medical Science Liaison Team in process and completion of key medical affairs initiatives.
• Identify, develop and maintain relationships with KOLs within the therapeutic areas.
• Identify gaps in communication and literature and propose solutions to address these needs.
• Participate in the ISR process and grant review process for related projects.
• Provide medical/clinical support for any payor related issues.
• Participate in cross-functional teams to represent medical affairs strategy and tactics.
• Phase IV study execution.
• Rare Disease Registry Study implementation.
• Ph.D., PharmD, MD (preferred) in Life Science or other related discipline. Equivalent combination of education and applicable job experience may be considered.
• At least 12 years of Medical Affairs experience preferably within Gastroenterology/Hepatology and/or pediatrics.
• Rare Disease experience is essential.
• Strong therapeutic area knowledge, development of strategic plans, publication planning, KOL development, experience with Phase IV research, Registries, cross-functional collaboration.
• Strong interpersonal and organizational skills and excellent verbal and written communication skills are required
• Cross-functional collaboration and the ability to successfully develop and lead high-functioning teams
• Must possess ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards.
• Ability to travel up to 40% domestic and internationally.