Serve as the project physician and provide medical and scientific expertise to project teams.
Ensure accuracy and integrity of trial data with concentrated focus on patient safety.
Work closely with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement.
Support Business Development and Proposals teams: participate in RFP process, prepare medical considerations for proposals, support/participate in bid defense meetings.
Write or edit scientific content of deliverables within budget and timelines; create content for white papers and publication manuscripts.
Collaborate with Regulatory Affairs on regulatory product landscape and drug development strategies.
Review and revise protocols, case report forms, training materials, project 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; assume responsibility for medical and safety monitoring on assigned projects.
Assist in preparation of the Medical Monitoring Plan and materials for investigator meetings and staff training sessions.
Participate in feasibility discussions related to specific project proposals and develop disease-state training modules.
Participate in process improvement activities and collaborate with VP, Global Medical to support global Medical Science Department growth.
Requirements
MD, DO, MBBS, or equivalent medical qualifications.
5+ years of Hematology clinical experience.
Ability to strategically analyze Hematology and oncology clinical trial protocols.
Availability for domestic and international travel including overnight stays (approximate 30% travel requirement).
Hematology Fellowship or equivalent (preferred).
Maintains current scientific and medical knowledge base (preferred).
Ability to deliver on commitments and understand the service culture.
Strategic thinker who can build drug development solutions, novel study designs, and patient population strategies.
Demonstrates professionalism, punctuality, and positive interpersonal skills.
Strong verbal and written communication skills; ability to conduct formal presentations.
Strong visual and presentation skills.
Ability to work effectively in a fast-paced team setting with minimal supervision.