Precision Medicine Group · 10 hours ago
Medical Director
Precision Medicine Group is a company focused on providing medical and scientific expertise in clinical trials. The Medical Director will ensure data accuracy and patient safety while participating in the strategic planning and execution of development programs for clients in oncology or autoimmune disease.
BiotechnologyHealth Care
Responsibilities
Work closely with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement
Support Business Development and Proposals teams by participating in the RFP process; prepare medical considerations section for proposals; and support or participate in bid defense meetings
Write or edit scientific content of deliverables within budget and timelines
Collaborate with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy
Provide scientific insight and create content for specified company releases (e.g., white papers and publication manuscripts)
Review and revise protocols, case report forms, training materials, project specific tools, analysis plans, study designs, clinical trial reports and new drug applications
Review laboratory values, adverse events, coded adverse event and medication data, and data tables, listings and figures as needed
Serve as a medical resource for study sites, the project team and clients
Assist in the preparation of the Medical Monitoring Plan and materials for investigator meetings and staff training sessions
Assume responsibility for medical and safety monitoring on assigned projects
Participate in feasibility discussions relating to specific project proposals
Develop training modules and provide training concentrating on disease states
Participate in process improvement activities
Collaborate with Senior Vice President, Global Medical and other members of the Medical Science Department to support growth and development activities globally
And other job duties as assigned by the line manager
Qualification
Required
MD, DO, MBBS, or equivalent medical qualifications
5+ years of clinical experience
Completed an accredited medical residency program
Completed a fellowship or equivalent relevant to assigned programs (e.g., oncology and/or hematology; rheumatology; allergy & immunology; endocrinology; gastroenterology; nephrology; neurology; or other related subspecialty)
5+ years of experience in oncology or autoimmune disease clinical research (depending on client and/or program assignment)
Demonstrated expertise across the lifecycle of oncology or autoimmune disease drug development, with ability to strategically analyze clinical trial protocols in the assigned therapeutic area
Availability for domestic and international travel including overnight stays (approximate 30% travel requirement)
Preferred
Drug development experience in oncology or autoimmune diseases (depending on program needs)
Board Certification in Oncology and/or Hematology, or in a relevant medical subspecialty aligned to assigned programs, or equivalent
Phase I and Phase II clinical trial experience in oncology or autoimmune disease
Prior CRO experience
Maintains current scientific and medical knowledge base
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.