Medical directors of Oncology Clinical Research

3 weeks ago


Los Angeles, United States TANNER & ASSOC INC Full time
Medical Directors of Oncology Clinical Research

Tanner and Associates is recruiting several Medical Directors of Oncology Clinical Research for large Biotech companies located in San Francisco, Los Angeles, Salt Lake, and New Jersey. Candidates can be based out of any of these locations.

Requirements:

Major Biotech companies are seeking Medical Directors/Clinical Scientists with drug development experience to join the Oncology program. Candidates should have an M.D. with board certification/eligibility in hematology/oncology, or a PhD/PharmD with at least 5 years of drug development experience. Prior experience in clinical trials in an oncology–related field is preferred. Candidates must be comfortable proactively solving issues and working independently.

Job Duties and Responsibilities:

The responsibilities are primarily focused on the design, implementation, analysis, and interpretation of clinical trials from phase I–III. The candidate will be expected to contribute significantly to the strategic direction of the Oncology programs, including clinical trial design, implementation, analysis, interpretation, and dissemination of results. Additionally, the candidate will be required to build and maintain excellent relationships with outside parties, including clinical investigators, advisors, regulatory authorities, and collaborating companies.

Responsibilities:

Design:

Design clinical experiments, including drafting protocol summaries and providing clinical input to complete protocols.Provide initial clinical designs for future trials, partnering with research, translational oncology, biostatistics, clinical operations, regulatory, and pharmacology for input/alignment and presentation at Therapeutic Development Team meetings.Serve as a key member of the Clinical SubTeam, providing significant input into clinical development/strategy.

Implementation:

As Medical Monitor, be responsible for all aspects of certain key clinical trials as per ICH/GCP guidelines.Partner with Data Management for CRF and tables, listings, and figures design and data quality plan.Medical monitoring of Phase I–III trials, serving as the primary Clinical Science contact on the Protocol Execution Teams and the primary liaison for clinical operations and Medical Monitor inquiries from sites, monitors, and CROs.Perform regular clinical reviews of listings and partner with clinical operations/drug safety to develop a safety monitoring plan.

Analysis and Interpretation:

Analyze interim and final data, including interpretation and representation/explanation of the results in verbal and written format within and outside the company.Possess excellent technical understanding of oncology.Have an excellent technical understanding of the clinical trial process, particularly the role of the Medical Monitor, including compliance requirements and ICH guidelines.Exhibit excellent written and verbal communication skills.

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