Medical directors of Oncology Clinical Research—Salt Lake
Behavioral Health Market Context
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Qualifications
- •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,Pharm
- •D with at least 5 years of drug development experience
- •Candidates must be comfortable proactively solving issues and working independently
- •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
- •4 more items(s)
Responsibilities
- •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
- •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 Sub Team
- •Provide significant input into the clinical development/strategy
- •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 of interim and final data, including interpretation and representation/explanation of the results in verbal and written format within and outside the Company
- •9 more items(s)
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