Medical Director, Clinical Development

Location
94080, South San Francisco
Posted
Jun 29, 2018
Ref
R18-039-25-01
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

POSITION SUMMARY:
Reporting to the VP, Clinical Science & Drug Safety, the Medical Director manages the clinical development of drug candidates, including phase I-IV studies and across multiple therapeutic areas. The Medical Director will have a strong understanding of all phases of pharmaceutical drug product development, including clinical trial management, IND and NDA submissions, medical monitoring, GCP principles, and will have extensive experience in collaboration with Clinical Operations, Research and Clinical Pharmacology, Medical Affairs, Regulatory Affairs and other key stakeholders.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:
 •    Develop protocols to execute clinical development strategies
 •    Work cooperatively with Clinical Operations and designated CROs to execute the programs (e.g.  lead study start up and database lock medical monitoring activities; address medical monitor inquiries from sites or Operations; perform data and coding reviews; draft/present clinical slides for Investigators Meeting, Advisory Boards and therapeutic/monitor training; review draft CRFs, etc.)
 •    Participate as key member in portfolio management and clinical program planning
 •    Assure the Clinical Science department works closely with Research and Clinical Pharmacology, Medical Affairs and Regulatory as appropriate for effective execution of various programs
 •    Work with academic leaders/advisers to develop clinical strategy  
 •    Write/edit clinical reports, investigator brochures and clinical aspects of Regulatory submissions; supports all other Regulatory activities and NDA related questions
 •    Other duties commensurate with position as assigned
 •    Ability to travel may be required 


KNOWLEDGE AND SKILL REQUIREMENTS:
 •    M.D. degree with a minimum of 5 years industry experience, or comparable experience in the management and execution of phase I-III trials with credible compounds/established companies
 •    Board certified or eligible in either immunology, rheumatology, hematology or oncology preferred
 •    Demonstrated ability to independently evaluate, interpret and present complex scientific data
 •    Demonstrated ability to critically evaluate complex drug development programs
 •    Proven leadership and management experience
 •    Demonstrated ability to work within a multi-disciplinary team of peers and outside experts  
 •    Excellent communication (verbal and written) and presentation skills


Rigel Pharmaceuticals Inc. is an Equal Opportunity Employer with a commitment to diversity
All individuals are encouraged to apply.