Education and Qualifications
• Pharm.D., PhD, or M.D. or equivalent education.
• Preferable five to seven years clinical or clinical development experience in the biotechnology or pharmaceutical industry or a combination of academia and industry.
• Participated in clinical oncology studies.
The Medical Director will collaborate with company management, design, plan and develop clinical evaluation research studies in hematology oncology. He / She will prepare, author and maintain clinical development related documents including study synopses and protocols. Be responsible for study results for preparation of documents and publications. Support project teams with scientific information and provide progress updates related to the assigned clinical studies.
• Interact with investigators and thought leaders in hematology oncology to facilitate the design of clinical synopses and protocols.
• Research and assist in the selection of investigators for clinical studies.
• Collaborate with the clinical teams for a specific product candidate, design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
• Conduct appropriate literature research for the assigned clinical product candidate.
• Collaborate with clinical operations and other internal study team members to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
• Act as primary contact of the clinical study team for medical monitor inquiries with guidance and oversight of the Medical Monitor assigned to the clinical program.
• Collaborate with clinical operations and other team members in the development of agendas, training materials, and presentation for site visits, investigator meetings, and other study related venues
• Participate in internal safety meetings, analyzes and reports potential safety events.
• Collaborate with team members in clinical review and interpretation of study data in support for preparation of reports for health authorities including regulatory filing documentation and study close-out reports.
• Help to write and/or review product specific abstracts, publications, and supports the development of presentations for scientific meetings.
• Proactively provide feedback on emerging clinical and competitive trends.
• Demonstrate thorough understanding of both clinical and commercial strategies and priorities.
• Coordinate and facilitate oncology trials by developing and maintaining excellent working relationships with study investigators.
• Deliver high quality scientific presentations on investigational agents to physicians and other key external customers.
• Provide clinical education support for internal customers.
• Maintain clinical and technical expertise in the therapeutic area of Oncology.
• 10-25% travel requirement.
• May directly or indirectly supervise employee(s).
• Comprehensive and detailed knowledge of clinical trial implementation and drug development process.
• Good general knowledge of other related disciplines in the execution of clinical trials.
• Identifies and implements methods and procedures to achieve results with high quality.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Applies strong analytical and business communication skills.
• Highly organized and able to work under tight timelines
• Good public speaking and presentation skills
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
• Uses professional concepts and company’s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Networks with key contacts outside own area of expertise.