Medical Director/Sr Medical Director - Pulmonary

Thermo Fisher Scientific is hiring a Medical Director or Senior Medical Director for pulmonary and critical care work. The role provides medical oversight of clinical trials, so company SOPs, client directives, good clinical practice, and regulatory requirements are followed. It is a full-time remote position, with the employer listing the job location as Chapel Hill, North Carolina, United States, and the work performed in an office environment on a standard Monday through Friday schedule.

The level at which you are hired, Medical Director or Senior Medical Director, is decided during the consideration process based on education, experience, therapeutic area, and interview results.

What you will do

You manage all medical aspects of contracted tasks across the pharmaceutical product life cycle.

• Ensure tasks delegated to medical monitors are properly executed, and follow applicable regulations and ICH guidelines for clinical trials, regulatory documents, and safety issues, along with client SOPs and project-specific working practices.
• Provide medical consultation to team members and answer study-related medical questions, keeping communication open with associates and clients.
• Provide therapeutic and protocol training on assigned studies when requested.
• Help write and review documents including CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, and CTD modules so the medical content is accurate and complete.
• Monitor safety variables in clinical studies, including adverse events, laboratory abnormalities, changes in patient medical status, prescribed concomitant medication against protocol restrictions, and un-blinding requests.
• Discuss medical concerns with principal investigators and clients, such as interpretation of inclusion and exclusion criteria, using medical judgment in clinical decisions.
• Provide medical review of adverse events of special interest, serious adverse events, and clinical outcome events reported by study sites.
• Perform data review as specified in the client contract and data validation manual, including coding listings and full safety data, to assess potential safety concerns.

What they are looking for

An MD or equivalent is required. Active medical licensure is preferred but not required. Candidates should have clinical experience in Pulmonary/Critical Care and formal training such as residency or fellowship, plus patient treatment experience comparable to 2 years.

For the Senior Medical Director level, candidates need the same clinical background and one of the following: suitable clinical trial experience in a contract research organization, pharmaceutical company, or as a principal investigator, comparable to 1 to 2 years in the industry; or direct experience in safety or pharmacovigilance comparable to 2 years. Preference goes to individuals with clinical development or medical monitoring experience. In some cases, a combination of appropriate education, training, and directly related experience will be considered sufficient.

You must be legally authorized to work in the United States or Canada without sponsorship, and able to pass a background check that includes drug screening where applicable.

Skills and abilities

• Therapeutic expertise in Neurology
• Strong decision-making, problem solving, organizational, and analytical skills
• Excellent oral and written communication skills
• Working knowledge of relevant safety databases such as MedDRA
• Flexibility to travel domestically and internationally
• Ability to work independently, with attention to detail, and to process and prioritize sensitive complex information
• Proficiency in basic computer applications
• Fluent spoken and written English
• Interpersonal, influencing, and team building skills
• Understanding of FDA, ICH, EMA, and GCP guidelines
• Working knowledge of biostatistics, data management, and clinical operations procedures
• Ability to mentor and train other staff

Work environment and physical requirements

Work is performed in an office environment with exposure to electrical office equipment. There are occasional drives to site locations and occasional domestic and international travel. The role requires being frequently stationary for 6 to 8 hours per day, repetitive hand movement, frequent mobility, and occasional crouching, stooping, bending, and twisting of the upper body and neck. Light to moderate lifting and carrying of objects including luggage and a laptop, up to 15 to 20 lbs, is required. Regular and consistent attendance is expected.

Benefits

Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits.