Job Overview:
Provides medical direction for the conduct of early clinical trials. Responsible for supporting the development activities of proposed and ongoing projects in their area of expertise, as well as medical monitoring assigned clinical studies.
Summary of Responsibilities:
Company Focus:
- Contributes to the development of Company policies involving medical, safety, and therapeutics.
- Participates in process improvement activities across Fortrea.
- Performs other duties as assigned.
Client Relationship and Business Development Activities:
- Partnering with GCO to develop new and enhance existing client relationships where possible.
- Provides medical/scientific capabilities to clients as a participant of a proposal team.
- Performs site/investigator feasibility, builds relationships with investigators to support optimal recruiting and conduct of trials.
Managerial:
- Supports and participates in the recruitment process for department positions.
Leadership:
- Provides leadership to junior staff within clinical pharmacology.
- Participates and leads initiatives that serves the physicians within clinical pharmacology.
Therapeutic and Scientific Expertise:
- Develops training modules and materials and provides training in disease states and protocol specific requirements across the Fortrea.
- Participates in training opportunities to advance knowledge of drug development and good clinical practice guidelines.
- Serves as global lead project physician.
- Performs medical data review – reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed.
- Develops, reviews and revises protocol, case report forms, training material, project specific tools, analysis plans design, clinical trial reports and new drug applications.
- Prepares materials for investigator meetings and site initiation visits.
- Actively participates in investigator meetings and site initiation visits.
- Provides medical/scientific expertise to project teams.
- Responsible for medical and safety monitoring on assigned projects.
- Interacts with interdepartmental and external consultants as appropriate.
- Participates in feasibility discussions relating to specific project proposals.
- Participates in project risk assessment activities.
- Assists when needed with data safety monitoring board activities.
- Provides clinical and medical expertise to other Fortrea departments.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- MD Degree.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Ability to drive projects outside of medical perspective.
- Problem solving ability.
- Sees issues outside of own remit and is able to escalate.
Experience (Minimum Required):
- A minimum of 3-5 years of experience with substantial knowledge of drug development and extensive clinical research experience within the pharmaceutical/CRO industry in a specific therapeutic area.
Physical Demands/Work Environment:
- Overtime and weekend work as required.
- Varied hours may be required.
- Occasional drives to site locations, occasional domestic travel.
- Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments, and gloves.
- Exposure to biological fluids.
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
Learn more about our EEO & Accommodations request here.