Clinical Research Director

3 settimane fa

Milano, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

Unlock Meaningful Opportunities as a Senior Medical Director at Thermo Fisher Scientific

At Thermo Fisher Scientific, we're committed to empowering our customers to make a positive impact on a global scale. As a Senior Medical Director, you'll play a pivotal role in driving our mission forward by leading clinical/medical aspects of all phases of the clinical drug development process.

Key Responsibilities:

  • Provide strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process.
  • 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 and assessment of the extent to which the study(ies) has achieved clinical/regulatory objectives.
  • Act as a clinical/medical representative in meetings with external stakeholders, partners, and other external audiences as needed.

A Day in the Life:

  • Provide regional medical leadership, mentoring, and oversight to direct reports and global Medical Director physician team.
  • Serve as a consultant and spokesperson of the medical team.
  • Provide medical content and leadership of clinical studies.
  • Provide medical monitoring of Phase I-IV clinical studies.
  • Establish and approve scientific methods underlying the design and implementation of clinical protocols.
  • Monitor study subject safety.
  • Review adverse events, laboratory, and other clinical data.
  • 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 documents requiring medical expertise for the conduct of clinical trials.
  • Interpret, summarize, and document study data for regulatory documents, manuscripts, and other publications as required.
  • Collaborate with leading academic medical centers.
  • Guide and motivate clinical investigators.
  • Ensure study compliance by understanding and applying all relevant SOPs and GCPs.
  • Participate in long-term strategic planning.

Requirements:

  • MD degree, preferably with a (sub)specialty.
  • Minimum 5 years of clinical and clinical drug development experience.

About Us:

We're Thermo Fisher Scientific, a company dedicated to enabling our customers to make the world healthier, cleaner, and safer. Our team of 100,000+ colleagues shares a common set of values: Integrity, Intensity, Innovation, and Involvement. We're committed to accelerating research, solving complex scientific challenges, driving technological innovation, and supporting patients in need.

EEO/Affirmative Action Employer:

We're an EEO/Affirmative Action Employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

Accessibility/Disability Access:

We offer accessibility services for job seekers requiring accommodations in the job application process. Please submit a request by telephone at 1-855-471-2255. Messages left for other purposes will not receive a response.

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