Director, Medical Affairs
Medical Affairs | San Carlos, CA | Full Time
ChemoCentryx is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.
As a clinical-stage company with a broad portfolio in multiple therapeutic areas, ChemoCentryx pushes beyond “good enough” and strives for a totally new way of healing.
The Director, Medical Affairs leads development and coordination of clinical research and other projects which provide medical and scientific expertise to several departments and functions for ChemoCentryx. The ideal candidate will have proven leadership ability in a fast paced environment and interact with all levels of internal staff, as well as external stakeholders, including, but not limited to CRO’s, Key Opinion Leaders and Advisory Boards and Committees. They will also work with Medical, Clinical, and other colleagues to develop and deepen productive relationships with external stakeholders and serve as a subject matter expert for assigned therapeutic areas.
Essential Duties and Responsibilities
- Partner with Medical Affairs, Clinical, Program Leadership, Market Access and Market Development, and others to develop and support the external engagement strategy for assigned programs.
- Collaborate in building a high-impact medical and scientific platform, including: scientific exchange and partnership with KOLs, medical communication and publication plans, scientific congress activities, medical education programs, scientific advisory boards and a post-approval evidence generation plan (LCM).
- Provide subject matter expertise to external and internal stakeholders
- Support identification and management of, and build relationships with, key external stakeholders including, but not limited to, healthcare providers, payors, healthcare institutions, and advocacy groups.
- Support Clinical Development in study site engagement and identification and vetting of potential clinical study sites.
- Contribute to the development of a broad range of Medical Affairs deliverables.
- Partner with internal and external stakeholders to develop and implement real world evidence generation strategies for assigned programs.
- Ensure all activities are conducted with the highest levels of scientific rigor and in full compliance with applicable rules and regulations.
- Have a board-certified MD or PhD, with clinical trial experience; a graduate degree in business management, health policy or healthcare administration in addition to a MD or PhD is desirable.
- 8+ years of relevant experience working directly in the Pharmaceutical/Biotechnology industry with at least 4 years' experience in Medical/Scientific/Clinical Affairs including real world evidence generation and external engagement roles.
- Scientific knowledge and experience in the area of renal and/or autoimmune diseases.
- Experience in the evolving healthcare system, with payers, IDNs or both.
- Successfully supported the launch of multiple transformative drugs; preferably in the rare disease space.
- Medical science background with a strong understanding of clinical research and clinical trial design and management
- Strong and consistent track record of success, developing strategy and executing operational plans.
- Possess a strong understanding of medical management principles and experience with supporting data analytics focused on outcomes analysis and management.
- Intimate understanding of the role of healthcare regulators and compliance.
- Proven ability to develop and grow productive relationships with external and internal stakeholders in a range of disciplines.
- Demonstrated ability to present complex scientific and medical information to a range of audiences.
- Ability to form strong relationships based on credibility and trust, be able to work within teams and handle a fast-paced work environment
- Comfortable with ambiguity and uncertainty.
- Experience transitioning from pre-commercial to commercial stage within an organization a plus.