(Associate) Medical Director - Neurology

Overview

(Associate) Medical Director - Neurology position at Thermo Fisher Scientific. Standard (Mon-Fri) work schedule. Office environment.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Our teams contribute to clinical research through the PPD clinical research portfolio, spanning laboratory, digital and decentralized clinical trial services.

Responsibilities

• Provide medical leadership to study teams, including creating clinical trial protocols while implementing the latest scientific information; contribute to site selection; involvement 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 to ensure medical validity of primary endpoints and subject safety; identify medical issues early and address them in consultation with the Global Medical Indication Lead
• During initial protocol review, consult with internal groups regarding procedural and budgetary items and changes due to protocol amendments; ensure cross-functional dedication to close gaps and address issues timely
• Serve as chief liaison between sponsor and all PPD, coordinating with Thermo Fisher Scientific internal departments during all study phases
• Educate Investigator sites by delivering protocol-specific lab procedures presentations and demonstrations at investigator meetings; manage day-to-day study activities to resolve issues and answer queries
• Act as medical point of contact for internal and external stakeholders; interact with investigators, address questions from IRBs and Health Authorities, and present materials to the study executive and independent safety committee if applicable; provide medical training of site staff at Investigator meetings; CRA training in new indications
• Ensure study compliance for all medical aspects by understanding and applying relevant SOPs and GCP
• Collaborate with cross-functional study team members to clearly communicate medical risks, issues, and results to all involved parties

Education

• MD, MB/BS or equivalent degree and strong medical knowledge with clinical experience managing Neurology patients in hospital practice

Knowledge, Skills, Abilities

• Significant experience within the pharmaceutical industry, clinical trials and pharmaceutical medicine
• Fluent in spoken and written English
• Understanding and experience with NDA submission process
• Understanding of regulatory guidelines for adverse event reporting
• Strong communication and presentation skills and a collaborative teammate

Our Mission is to enable our customers to make the world healthier, cleaner and safer. We are a global team of 100,000+ colleagues with values including Integrity, Intensity, Innovation and Involvement. #StartYourStory with PPD, part of Thermo Fisher Scientific.

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.

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Research and Science

Industries

• Pharmaceutical Manufacturing and Biotechnology Research