Medical Director, Clinical Development

Location: San Diego, CA

Type: Full Time Permanent

Salary: Competitive

A late-stage biotechnology company in the San Diego area focused on advancing new treatments that target the genetic and immunological drivers of cancer is looking to hire a Medical Director, Clinical Development to join their team. They are looking to advance a novel pipeline across multiple programs and tumor types among which are non-small cell lung cancer.

Scope:

My client is looking for a Medical Director to join the clinical team and provide clinical leadership to the company's global oncology clinical trials. The ideal candidate will be a professional with a M.D. degree with at least 2 years of drug development experience in Oncology. The hiring manager, the VP, Innovative Medicine Development, is looking for a candidate who has a passion for novel science and thinks beyond the day-to-day execution.

Responsibilities:

Ensure clinical studies are following clinical development plan in accordance with all requirementssuring that studies are carried out in accordance with GCPs, ICH and FDA and other regulatory authority requirements.
Primary Medical monitor
Update clinical staff and upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues and implement plan to resolve issues
Produce required clinical study documents
responsible for interpretation of data to understand safety and efficacy
Assist in preparation of clinical sections of key regulatory documents, e.g., IND annual reports and briefing packages
Assist in case report form (CRF) development and data analysis plans
Perform in data cleaning and clinical study report review

Requirements:

Medical Doctor (M.D.) and at least 2 years involvement in oncology drug development
Understanding of clinical trial design, methodology and statistical concepts.
Phase IIII oncology clinical trial experience preferred.
Working knowledge of the IND/NDA process preferred.
In-depth knowledge of GCP/ICH guidelines preferred.

I am a Clinical Development market expert working with a large variety of clients across the Biotech and Pharmaceutical industries. If this role isn’t of interest to you, but you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Nikita Madan at 619-350-6341 or at n.madan@hamlynwilliams.com

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