Participate in the development and implementation of the clinical strategy, in collaboration with the clinical/medical/regulatory team. Fulfill a key strategic role within the company by leading and managing some aspects of clinical development to ensure project goals; report to the Senior Medical Director, Clinical Development.
- In collaboration with the medical team, design, initiate and manage clinical trials, including four phase 3 studies enrolling a total of approximately 800 patients in the U.S. and Europe through Clinical Research Organizations.
- Interact effectively with the clinical operations team to provide guidance on medical and clinical issues for the nephrology pipeline.
- Collaborate with the Executive Director, Regulatory Affairs to address all relevant regulatory challenges.
- Participate in the development and management of the physician scientific advisory board and interaction with investigators.
- In collaboration with the Director of Drug Safety and the clinical development team, manage safety and other medical monitoring responsibilities.
- Direct the analysis and presentation of data to internal teams, management and at scientific meetings.
- Provide strategic input to company research activities.
- M.D., with at least 3 years of industry experience; experience in Phase 2 or 3 studies is required; Board Certification is highly desired.
- Record of clinical achievements, including experience designing and conducting clinical trials.
- Experience applying GCP and regulatory requirements for drug development.
- Proven ability to work closely in a team environment as well as to work independently as a problem solver.
- Strong relationship management skills – ability to influence and motivate a team.
Affymax, Inc.
Human Resources
4001 Miranda Avenue
Palo Alto, CA 94304
careers@affymax.com
