The Medical Director Late Stage Development, is responsible for establishing and leading clinical activities for programs after proof of concept is obtained. This position will partner with other members of the Clinical Development, Clinical Operations, and Regulatory departments to develop Phase 2 and 3 protocols, and collaborate on biomarker and potential companion diagnostic strategies.
Specific Job Duties
Develop, implement and manage Late Stage Development strategy in collaboration with internal and external R&D partners, other members of the Clinical Development, Clinical Operations, and Regulatory departments.
Responsible for the developing, implementing and managing Phase 2 and 3 studies in partnership with other functional areas. This includes assessment of medical need and biomarker components of Phase 2 and 3 studies
In close collaboration with research scientists (internal and external), identify, develop, and implement strategy for clinical support of program-related objectives.
Develops the Phase 2 and 3 strategies, including recommendations regarding endpoints, design, safety evaluations, and initial dose selections.
Collaborate with and provide leadership to study management teams and global project teams by providing medical and scientific leadership and expertise to all line functions on the project team.
Collaborate and provide input on compound related biomarker strategies; works closely with Biomarker experts in implementation. Collaborate with teams on developing clinical biomarker strategies.
Participate in Health Authority (HA) interactions.
Facilitate the establishment and maintenance of effective collaborations with academic institutions and patient foundations.
Provide scientific input and advice for internal committees and collaborate with other R&D related activities.
Represent company externally at scientific meetings, advisory boards, and through high impact presentations, publications, and other scientific communications
Collaborate with cross-functional teams to identify and leverage external partnerships and interactions with academic, government, and industrial laboratories
Up to 25% travel as needed
Skills, Minimum Education, and Experience
MD degree, with subspecialty training in oncology
3-5 years of hands on pharmaceutical or biotech experience in clinical development in oncology. Experience in translational medicine/biology, pharmacology or directly related discipline, a plus.
Broad knowledge of Oncology. Excellent scientific knowledge in Translational Medicine within the oncology field is highly desirable.
Experienced in planning, control and monitoring of complex and highly visible drug development projects and activities.
Strong communication and leadership skills with experience in entrepreneurial, growing organizations
Ability to travel in the U.S. and Internationally
Type:DirectLocation:South San Francisco, CA