Job Description
* * * MEDICAL DIRECTOR, ONCOLOGY * * *
The Medical Director, Clinical Development & Medical Affairs will be responsible for the safety and medical monitoring activities of multiple clinical trials, and will also participate in the development and authorship of clinical trial protocols, data analyses, clinical study reports, and other clinical documents. The position may involve both pre-marketing and post-marketing clinical trials. The position will have direct and functional reporting responsibilities to the VP of Clinical Development & Medical Affairs.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
-MD degree
-Minimum of 5 years of clinical practice patient care experience strongly preferred
-BE/BC preferred, ideally in oncology, but not required; if not oncology, broad based specialty training desired (e.g., internal medical, family medicine, etc.).
-Minimum of 3 years of applicable industry experience in a biotechnology or pharmaceutical company essential, in a job position performing most or all of the responsibilities in this job description, preferably in a fast-paced, dynamic environment
-Excellent working knowledge of FDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development
-Intimate knowledge of and high level expertise in the day-to-day medical monitoring of pre-marketing clinical trials (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports)
LOCATION: Southern California
HOW TO APPLY:
For immediate consideration, send CV to Dorothy Lackland at FAX Register or log in for contact information or E-mail Register or log in for contact information.