Medical Director

3 giorni fa

Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
About the Role

This is a senior leadership position responsible for providing strategic direction and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process.

Key Responsibilities
  • Design, develop, and execute Clinical Development Plans (CDPs), clinical trials, and protocols in accordance with applicable GCP regulations.
  • Lead and contribute to the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives, and the documentation of study results.
  • Act as a clinical/medical representative in meetings with external stakeholders, partners, and other external audiences as needed.
  • Provide medical content and leadership of the clinical studies.
  • Medical Monitoring of clinical studies.
  • Establish and approve scientific methods underlying the design and implementation of clinical protocols.
  • Ensure study subject safety.
  • Regularly review adverse event, laboratory, and other clinical data, 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, review, and approve 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
  • MD degree with specialization in Psychiatry/Neurology is mandatory.
  • Drug Development experience in the area of Psychiatry/Neurology.
  • Desirable: Experience in the therapy areas of (Monoclonal Antibodies) and/or Translational Medicine.
Preferred Qualifications
  • 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.
  • Ability to travel.
About Thermo Fisher Scientific

Thermo Fisher Scientific is a leading provider of scientific instrumentation, reagents, and services. Our mission is to enable our customers to make the world healthier, cleaner, and safer. We value diversity, inclusion, and innovation, and we are committed to accelerating research, solving complex scientific challenges, and supporting patients in need.

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