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.
Discover Impactful Work :
The (Associate) Medical Director will provide medical support and advice for clinical trials and safety evaluation within the Pharmacovigilance department.
A day in the Life :
1. Provide medical leadership to study teams, including creating clinical trial protocols, implementing the latest scientific information, contributing to site selection, and reviewing and approving study protocols, amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviations, and other clinical documents.
2. Monitor clinical studies in real time to ensure medical validity of primary endpoints and subject safety, identifying medical issues early. Address customer concerns proactively and correct issues in consultation with the Global Medical Indication Lead.
3. Review protocols during initial stages, consulting with internal groups and support staff regarding procedures and budgets, and managing protocol amendments. Serve as the chief liaison between the sponsor and PPD, and educate investigator sites through protocol-specific presentations during investigator meetings. Manage daily activities during trials to resolve issues and answer queries.
4. Act as the medical point of contact for internal and external stakeholders, interacting with investigators, responding to IRBs and Health Authorities, and preparing materials for study committees. Provide medical training to site staff and CRAs.
5. Ensure study compliance with all relevant SOPs and GCP guidelines.
6. Collaborate closely with cross-functional study team members to clarify medical risks, issues, and results.
Education :
* MD, MB/BS, or equivalent degree with strong medical knowledge, particularly clinical experience in neurology.
Knowledge, Skills, Abilities :
* Extensive experience in the pharmaceutical industry, clinical trials, and pharmaceutical medicine.
* Fluency in spoken and written English.
* Understanding of NDA submission processes and regulatory guidelines for adverse event reporting.
* Excellent communication and presentation skills, with a strong team orientation.
Apply today!
Thermo Fisher Scientific is an EEO / Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
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