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Thermo Fisher Scientific

Medical Director/Clinical Trial Physician - Neurology(Client Dedicated)

Thermo Fisher Scientific, Columbia, South Carolina, United States

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Medical Director/Clinical Trial Physician - Neurology(Client Dedicated)

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Medical Director/Clinical Trial Physician - Neurology(Client Dedicated)

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Thermo Fisher Scientific . Work Schedule:

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Office 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. Location/Division Specific Information:

Join Thermo Fisher Scientific as a Medical Director/Clinical Trial Physician (FSP) based in the United States. The ideal candidate location is in the Eastern or Central Time Zone. This position is fully remote, benefit-eligible, with travel in a 10-20% range (international travel may be required). Our client, a global mid-sized biotech company, focuses on developing innovative treatments for patients with autoimmune diseases. This fast-growing, international organization has a strong scientific foundation. If you're looking for a place where your work, in partnership with others, can have real impact—and where you're encouraged to challenge yourself and contribute to breakthrough solutions, the Medical Director/Clinical Trial Physician could be a great fit. Discover Impactful Work: Provides clear medical leadership in the study team, working in close collaboration with other cross-functional team members to provide reliable, high-quality study data within time and budget. A day in the Life: Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information. Contribute to site selection, review and approval of study protocols and amendments, CSRs, ICFs, CRFs, protocol deviation decisions, and other clinical documents as required. Real-time medical monitoring of clinical studies: ensure medical validity of primary endpoints and study subject safety, with early identification of medical issues. Proactively escalate and correct issues in consultation with the Global Medical Indication Lead. Interpret clinical trial data for regulatory documents (e.g., CSR, INDs, Annual Reports, NDAs, MAAs), manuscripts, and publications in consultation with the Indication Lead. Serve as the medical point of contact for internal and external stakeholders: interact with investigators, answer questions from IRBs and Health Authorities, prepare and present materials to study committees, provide medical training at Investigator meetings, and train CRAs in new indications. Ensure study compliance with all relevant SOPs and GCP guidelines. Collaborate closely with cross-functional study team members to ensure clarity on medical risks, issues, and results. If more than one physician is working on the protocol, a primus inter pares will be appointed to harmonize responses to sites, IRBs, RAs, eligibility, and protocol deviations across medical team members. Keys to Success: Education: Medical Doctor or equivalent degree required. Board certification(s) preferred. Specialty training (e.g., residency/fellowship) required in neurology, with patient treatment and/or research experience. 1-3 years of industry experience in clinical development within pharmaceutical, biotech, or CRO organizations. Neurologists with expertise in Pediatric Neurology or Neuromuscular diseases are highly preferred. Knowledge, Skills, Abilities: Excellent English communication skills, both written and spoken, and ability to travel. Understanding of NDA submission processes and regulatory guidelines for adverse event reporting. Interpersonal skills to lead study teams, provide medical advice, and exercise judgment on escalation issues. Proactive problem-solving, negotiation skills, and cultural sensitivity in a global environment. Strong communication skills for collaboration and transparency within cross-functional teams. Physical Requirements / Work Environment: Work in an office environment with exposure to electrical equipment. Occasional domestic and international travel. Stationary work for 6-8 hours, with frequent mobility and light lifting (up to 20 lbs). Ability to communicate effectively, perform under stress, and multitask. Consistent attendance required. Benefits:

Competitive remuneration, annual incentive bonus, healthcare, and other employee benefits. Join an innovative organization with strong career development prospects and a culture of integrity, involvement, and innovation.

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