Medical Director - Sleep Disorders

ThermoFisher Scientific; United States; À distance; USD 180 000 - 250 000; Plein temps

Résumé du poste

Thermo Fisher Scientific seeks an Associate Medical Director to provide medical oversight of clinical trials, ensuring SOPs, GCP and regulatory requirements are followed. You will attend investigator and sponsor meetings, provide medical consultation to clients and project teams, and oversee safety reviews across SAEs, DSURs and CSR documents.

The role requires an MD with neurology and sleep disorders experience, plus substantial clinical trial or PV experience.

Qualifications

• MD with neurology specialization focused on sleep disorders.
• Experience in clinical trials and pharmacovigilance is required.
• Strong communication and regulatory knowledge are essential.

Responsabilités

• Provide medical oversight of contracted clinical trials across product life-cycle.
• Attend investigator and sponsor meetings and provide medical consultation to clients and teams.
• Review safety data (AE/SAE), CSR, IND/NDA, ICSR, PSUR/DSUR and other regulatory documents.

Connaissances

Medical oversight

Regulatory compliance

GCP & SOPs

Pharmacovigilance

Clinical trial monitoring

English fluency

Formation

Medical Doctor (MD) with neurology and sleep disorders

Description du poste

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as an Associate 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 Associate 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:

Medical Doctor, with a specialty in Neurology with focus in Sleep disorders, shown clinical experience running patients with Sleep disorders in hospital practice

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).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities:

Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine is critically important

• Solid experience with PIPs (pediatric investigation plan)
• Is fluent in spoken and written English
• Shown understanding and experience with NDA submission process.
• Shown understanding of regulatory guidelines for adverse event reporting
• Strong communication & presentation skills and is a strong teammate

Why join us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does 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.