Medical Director Job at Thermo Fisher Scientific

Thermo Fisher Scientific is hiring for the role of Medical Director!

Responsibilities of the Candidate:

• Provide medical content and leadership of the clinical studies
• Establish and approve scientific methods underlying the design and implementation of clinical protocols
• Ensure study subject safety
• Review adverse events, laboratory and other clinical data, and ensure reporting is done on a timely basis
• Collaborate with the study executive and independent safety committee when needed
• Represent clinical research through membership on trial teams.
• Contribute to, reviews, and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents as required for the conduct of clinical trials
• Interpret, summarize and document clinical data for regulatory documents (e.g. INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required.
• Collaborate with leading academic medical centers
• Recruit, guide, and motivate clinical investigators
• Ensure study compliance by understanding and applying all relevant SOPs and GCPs
• Participate in long-range strategic planning

Requirements:

• Demonstration and commitment to vigilant proactive problem solving
• Excellent leadership abilities
• Able to provide multiple examples of creating and implementing the scientific and clinical principles used for the preparation of clinical studies and clinical trial protocols.
• Demonstrated expertise in clinical trial design, conduct, and interpretation of clinical data.
• Previous experience with regulatory submissions.
• Excellent written and verbal communication skills