Senior Medical Director

ThermoFisher Scientific; San Isidro; On-site; PEN 311,000 - 484,000; Full time

Job summary

Thermo Fisher Scientific seeks a Medical Director to provide medical oversight of clinical trials, ensuring SOPs, ICH/GCP compliance, and regulatory adherence. You will attend investigator and sponsor meetings, provide medical consultation to clients and teams, and support business development with medical insights.

MD or equivalent is required, active licensure preferred, with clinical trial and safety/pharmacovigilance experience.

Qualifications

• MD or equivalent required; active medical licensure preferred.
• Clinical trial experience in CRO/pharma or as a principal investigator recommended.
• Experience in safety/pharmacovigilance and regulatory requirements.
• Ability to provide medical consultation and ensure SOP/GCP compliance.

Responsibilities

• Manage medical aspects of contracted tasks across the product life-cycle.
• Provide medical consultation to team members, clients and investigators.
• Review CSR, IND/NDA, ICSR, signal detection reports and other safety documents.
• Monitor safety variables and discuss clinical concerns with investigators and sponsors.

Skills

Medical oversight

Clinical trial knowledge

Regulatory compliance

Medical consultation

Education

MD or equivalent

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Medical Director – Make an Impact at the Forefront of Innovation

At Thermo Fisher Scientific, you’ll 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 provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

What You'll Do:

Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle.

General Support:

• Ensure tasks delegated to PV are properly executed. Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Follow client SOPs/directives and project-specific WPDs for assigned projects. Comply with CRG’s corporate policies and SOPs/WPDs.
• Provide medical consultation to team members and answer all study-related medical questions. Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provide therapeutic training and protocol training on assigned studies, as requested.
• Assist in writing (interpretation of safety and efficacy data) and/or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure that the medical content is accurate and complete.

Clinical Trial Support:

• Monitor all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
• Discuss all medical concerns with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in interpretation and decision-making regarding clinical situations as they relate to the investigational study.
• Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites.
• Perform data review as specified in the client contract and data validation manual, including review of coding listings and/or full safety data to assess potential safety concerns.

Marketed Products Support:

• Manage signal detection activities, scientifically review aggregate reports, contribute to label updates, and support dossier maintenance and risk management activities.
• Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.

Education and Experience Requirements:

• MD or equivalent required. Active medical licensure preferred.

Medical director candidates should have at least one of the following:

• Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years).
• Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry.
• Direct experience in safety/Pharmacovigilance (comparable to 2 years).

For Senior Medical Director:

• MD or equivalent required. Active medical licensure preferred.

Candidates should have a combination of clinical experience and industry experience as follows:

• Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 5 years) and one of the following:
• Suitable clinical trial experience in a Contract Research Organizatio