Medical Director/Medical Director
4 days ago
We are seeking a highly skilled and experienced Medical Director to join our team at Thermo Fisher Scientific. As a Medical Director, you will play a critical role in ensuring the medical oversight of clinical trials, ensuring that company SOPs, client directives, good clinical practice, and regulatory requirements are followed.
Key Responsibilities:- Provides medical oversight of clinical trials to ensure compliance with company SOPs, client directives, good clinical practice, and regulatory requirements.
- Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators, and project team members, and supports business development activities.
- Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR, and periodic safety reports (PBRER, PSUR, DSUR) as well as other client deliverables (labeling reconciliation documents, CTD modules, REMS, RMP, and CSR).
- MD or equivalent required. Active medical licensure preferred.
- Candidates should have at least one of the following: clinical experience in treating patients as an Ophthalmologist (minimum 2 years), suitable clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator (comparable to 1-2 years) in the industry, or direct experience in safety/Pharmacovigilance (comparable to 2 years).
- Industry experience is required for Med Dir level.
- Therapeutic expertise across one or more medical specialty or sub-specialties.
- Strong decision-making, problem-solving, organizational skills, and analytical skills.
- Excellent oral and written communication skills.
- Working knowledge of relevant safety databases (Medra).
- Flexibility to travel domestically and internationally.
- Ability to work independently, analyze work with attention to detail, process, and prioritize sensitive complex information.
- Proficiency in basic computer applications.
- Fluent in spoken and written English.
- Excellent interpersonal, influencing, and team-building skills.
- Understanding guidelines (FDA, ICH, EMA, and GCP).
- Working knowledge of biostatistics, data management, and clinical operations procedures.
- Ability to act as a mentor/trainer to other staff within PV.
- Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations with occasional travel both domestically and internationally.
- Frequently stationary 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.
- Frequent mobility required.
- Occasional crouching, stooping, bending, and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.
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