Medical directors of Oncology Clinical Research
2 weeks ago
Medical directors of Oncology Clinical Research – San Francisco
Tanner and Associates is recruiting several Medical directors of Oncology Clinical Research for several large Biotech companies located in San Francisco, Los Angeles, Salt Lake, and New Jersey. Candidate can be based out of any of these locations.
Requirements:
Several Major Biotech companies are seeking Medical Director/Clinical Scientist with drug development experience to join the Oncology program. The candidate 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 of clinical trials in an oncology related field is preferred. Candidates must be comfortable proactively solving issues and working independently.
Job Duties and Responsibilities are primarily focused, but not restricted to the design, implementation, analysis and interpretation of clinical trials from phase I-III. The candidate will be expected to make a significant contribution to the strategic direction of the Oncology programs, including clinical trial design, implementation, analysis, interpretation and dissemination of results as detailed below. In addition the candidate will be required to build and maintain excellent relationships with outside parties including clinical investigators and advisors, regulatory authorities and other Government institutions (eg NCI), and collaborating companies.
Responsibilities:
Design:
Design of clinical experiments, including drafting of protocol summaries and providing clinical input to complete protocols
Provide initial clinical designs for future trials including partnering with research, translational oncology, biostatistics, clinical operations, regulatory and pharmacology for input/alignment and presentation at the Therapeutic Development Team meetings
Serve as a key member on the Clinical SubTeam. Provide significant input into the clinical development/strategy
Implementation:
As Medical Monitor, to 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 including serving as the primary Clinical Science contact on the Protocol Execution Teams(s) and the primary liaison for clinical operations and the primary point of contact for Medical Monitor inquiries from sites, monitors and CROs
Perform regular clinical review of listings and partner with clinical operations/drug safety to develop a safety monitoring plan
Analysis and Interpretation:
Analysis of interim and final data, including interpretation and representation/explanation of the results in verbal and written format within and outside the Company
Excellent technical understanding of oncology
Excellent technical understanding of the clinical trial process and in particular the role of the Medical Monitor, including compliance requirements, ICH, etc
Excellent written and verbal communication skills
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