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Medical Director – Clinical Development

Job Juncture

This is a Full-time position in San Diego, CA posted June 20, 2021.

Email Address

We are searching for a Medical Director to lead clinical development of promising drug candidates for a rapidly growing biopharmaceutical company.

The Medical Director will work with teams developing treatments for gastrointestinal disease like IBD as well as autoimmune disorders.

 
Requirements for Medical Director
– Clinical Development:
 
MD degree or DO BC or BE in internal medicine, subspecialty training in gastroenterology, rheumatology, or pulmonary medicine strongly preferred 7+ years of experience in clinical research, including the design and execution of clinical trials, preferably within a pharmaceutical or biotech environment.

Candidates with experience in a contract research organization
– CRO
– or academic institution will be considered.

Experience in novel and innovative designs for early studies, Phase I and II is required; Phase 3 trial experience is a plus.

Experience with U.S.

and European Health Authority interactions and submission of clinical regulatory documents preferred Strong written and verbal communication skills; the ability to work with investigators, key opinion leaders and external advisors; and ability to effectively give presentations at conferences, advisory meetings and other public forums.

Willingness to educate and mentor internal and external colleagues and collaborators.

A hands-on, entrepreneurial style with a sense of urgency, a bias toward action, comfort with calculated risk, and the ability to analyze situations rapidly and make prudent decisions Strong leadership skills with ability to work within and lead and motivate a cross-functional matrixed team.

 
 
Responsibilities of the Medical Director
– Clinical Development:
 
 
Provide clinical leadership of a comprehensive and integrated clinical development plan for inflammatory bowel disease and other autoimmune disease programs from first-in-human through registrational studies.

Develop study designs, lead protocol development, in collaboration with cross-functional teams, KOLs and health authorities.

Direct hands-on involvement in all aspects of study conduct, in collaboration with clinical operations and medical affairs, in the conduct of clinical activities including recruitment, data review, analysis, and reporting that conforms to the highest ethical, safety and quality standards and in compliance with GCP and regulatory standards.

Participate as clinical contributor in business development and investor-related activities; play a key role in Health Authority interactions.

Occupational Category: 29-1229 Physicians, All Other 
 
 

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