Medical Director - Pharmacovigilance

Position Overview

At Thermo Fisher Scientific, discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

The Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the PPD Pharmacovigilance department.

Responsibilities

• Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information.
• Contribute to site selection.
• Involved in review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials.
• Real-time Medical Monitoring of clinical studies:
  • Ensure medical validity of each individual primary endpoint as well study subject safety.
  • Ensure medical issues are identified early.
  • Pro-active customer concern and correction of issues in consultation with the Global Medical Indication Lead.
• During initial review of protocol, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments.
• Acquires other functions’ dedication to close gaps and address issues timely and effectively.
• Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during all study phases.
• Educates Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting.
• Controls, handles and follows day-to-day activities during the course of the clinical trial to resolve any issues and answer queries.
• Medical point of contact for all internal and external stakeholders:
  • Interact with the investigators as needed.
  • Answer questions of IRBs and Health Authorities.
  • Prepare and present material to the study executive and independent safety committee if applicable.
  • Provide medical training of site staff at Investigator meetings.
  • Provide CRA training in new indications.
• Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP.
• Closely collaborate with the cross-functional study team members in order for medical risks, issues, and results to be clear to all involved parties.

Requirements

• Education: MD, MB/BS or equivalent degree and strong medical knowledge.
• Experience:
  • Shown clinical experience running Nephrology patients in hospital practice.
  • Significant experience within the pharmaceutical industry, clinical trials, and pharmaceutical medicine is critically important.
  • Shown understanding and experience with the NDA submission process.
  • Shown understanding of regulatory guidelines for adverse event reporting.
• Skills:
  • Fluent in spoken and written English.
  • Strong communication & presentation skills.
  • Strong teammate.

Employment Details

• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office

Company Information

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate r