Reporting to the Chief Medical Officer, the Vice President, Medical Affairs will set overall strategy, build and have leadership responsibility for a premier global Medical Affairs function. He/She will guide the company’s efforts in several areas: Publications/Presentations, Investigator Initiated Research, Health Economics Research, Medical Education Grants, Medical Information, KOL Strategy and Development, Phase 3b/4 trials and MSL team leadership.
The candidate will ensure that Medical Affairs activities and initiatives are aligned with the Clinical R&D and Commercial organizations in order to achieve company strategic goals and maintain compliance with corporate policies and regulatory requirements. Communicating and working effectively across all functional disciplines and regions will be a key priority for this individual as the company continues to build towards the commercialization of its clinical candidates.
The candidate will be required to “hit the ground running”, demonstrate capability in a fast-paced environment, and function as an integral contributing member of the broader team. The candidate will have the opportunity to further develop and evolve the Medical Affairs function.
The ideal candidate will possess on the order of 10 years of experience in biopharmaceutical Medical Affairs with at least five of those years in a leadership role. This person will have demonstrated capability managing a strong team in a fast-paced environment and work well with a broader cross-functional organization. Experience successfully collaborating with corporate partners on drug development and commercialization agreements, ideally on a global basis, is a plus. While our Client is open to evaluating candidates with comprehensive experience in specialty therapeutics, exposure to rare disease products would be an advantage. Direct experience launching first in class therapeutics with high advocacy touchpoints is preferred. An M.D. is preferred. The ideal candidate will have experience building, training and motivating a Medical Affairs function for a mid-size company. The Vice President, Medical Affairs will have a strong understanding of all phases of product development, including preclinical development, clinical trial management, post-launch marketing, post-approval studies, regulatory affairs, GCP and manufacturing compliance. The candidate must have excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. This person will demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards. The successful candidate will be energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details.
Although this role will be domiciled in the South San Francisco office, the Vice President, Medical Affairs will need to travel extensively outside of the US, and prepare the organization for the potential of an initial product launch in Europe. Prior global medical affairs experience is required.