Job Description
San Diego area !
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.
-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
-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)
-Preferable to have knowledge and expertise in post-marketing pharmacovigilance, including the receipt and processing of post-marketing ADRs, completion of MedWatch forms, and generation of Periodic Safety Update Reports
-Demonstrated experience and expertise in the primary authorship of summaries of data from clinical trials
- able to act as an effective spokesperson for the company (e.g., at Investigator meetings and KOL meetings)
Base DOE $180-250. Bonus. Benefits.