Associate Medical Director - Medical Geneticist

November 19

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. • 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. • Ensures tasks delegated to pharmacovigilance are properly executed. • Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. • Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.

Requirements

• MD or equivalent required. • Active medical licensure preferred. • Clinical experience in treating patients in the specialty or sub-specialty associated with the applicant's training (comparable to 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. • Direct experience in safety/Pharmacovigilance (comparable to 2 years). • Qualified candidates should have a background as a formally trained Geneticist with clinical experience. • Excellent interpersonal skills, influencing and team building skills. • Understanding of guidelines (FDA, ICH, EMA and GCP).

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs. • Employee assistance and family support programs, including commuter benefits and tuition reimbursement. • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy. • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan. • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.