Thermo Fisher Scientific
Medical Director/Clinical Trial Physician - Neurology(Client Dedicated)
Thermo Fisher Scientific, Raleigh, North Carolina, United States
Medical Director/Clinical Trial Physician - Neurology (Client Dedicated)
Location: United States (Remote with travel 10-20%). Ideal candidate location is Eastern or Central Time Zone. Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office environment with potential domestic and international travel. At Thermo Fisher Scientific, you’ll contribute to meaningful work across global clinical trials and decentralized clinical trial services, delivering high-quality study data within time and budget. Overview
This role provides medical leadership within the Study Team, collaborating with cross-functional colleagues to support study conduct and data integrity for a global biotech client focused on autoimmune diseases. The Medical Director/Clinical Trial Physician participates in protocol development, medical monitoring, regulatory documentation, and training of site staff. Responsibilities
Provide medical leadership to study teams, including creating clinical trial protocols, contributing to site selection, reviewing and approving study documentation (protocols and amendments, CSRs, ICFs, CRFs), and making protocol deviation decisions. Perform real-time medical monitoring to ensure medical validity of primary endpoints and participant safety; proactively escalate and resolve issues with the Global Medical Indication Lead. Interpret clinical trial data for regulatory documents (e.g., CSRs, INDs, Annual Reports, NDAs, MAAs), manuscripts, and other publications in consultation with the Indication Lead. Serve as medical point of contact for internal and external stakeholders; interact with investigators, respond to IRB/Health Authority questions, and present material to study executives and safety committees as applicable; train site staff at Investigator Meetings and CRA training for new indications. Ensure medical compliance with SOPs and GCP guidelines; collaborate with cross-functional team members to clearly communicate medical risks, issues, and results. In multi-physician protocols, appoint a primus inter pares to harmonize responses to site/IRB/RA inquiries and decisions on eligibility and protocol deviations. Keys to Success
Medical Doctor or equivalent degree required; board certification(s) preferred. Specialty training in neurology (residency/fellowship) with patient treatment and/or research experience. 1-3 years of industry experience in clinical development within Pharma, Biotech, or CRO settings. Neurologists with expertise in Pediatric Neurology or Neuromuscular diseases are highly preferred. Knowledge, Skills, Abilities
Excellent English communication skills (written and spoken) and ability to travel. Experience with NDA submission process and understanding of regulatory guidelines for adverse event reporting. Strong interpersonal and leadership skills to guide a study team and provide medical advice while escalating issues as needed. Proactive problem-solving, cross-cultural awareness, and strong matrix-management communication. Effective collaboration with cross-functional teams; ability to gather decision information, negotiate, and communicate decisions and actions clearly. Physical Requirements / Work Environment
Office environment with exposure to standard equipment; occasional site travel (domestic and international). Typically 6-8 hours stationary per day; ability to perform repetitive movements of hands/fingers; regular mobility; occasional crouching, bending, and twisting. Light to moderate lifting (up to 15-20 lbs); ability to use computer software; strong listening and communication abilities; ability to work independently and manage multiple tasks under changing conditions. Regular and consistent attendance and ability to work under stress and multi-task as needed. Benefits
Competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. The company supports an innovative, forward-thinking culture focused on integrity, intensity, involvement, and innovation.
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Location: United States (Remote with travel 10-20%). Ideal candidate location is Eastern or Central Time Zone. Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office environment with potential domestic and international travel. At Thermo Fisher Scientific, you’ll contribute to meaningful work across global clinical trials and decentralized clinical trial services, delivering high-quality study data within time and budget. Overview
This role provides medical leadership within the Study Team, collaborating with cross-functional colleagues to support study conduct and data integrity for a global biotech client focused on autoimmune diseases. The Medical Director/Clinical Trial Physician participates in protocol development, medical monitoring, regulatory documentation, and training of site staff. Responsibilities
Provide medical leadership to study teams, including creating clinical trial protocols, contributing to site selection, reviewing and approving study documentation (protocols and amendments, CSRs, ICFs, CRFs), and making protocol deviation decisions. Perform real-time medical monitoring to ensure medical validity of primary endpoints and participant safety; proactively escalate and resolve issues with the Global Medical Indication Lead. Interpret clinical trial data for regulatory documents (e.g., CSRs, INDs, Annual Reports, NDAs, MAAs), manuscripts, and other publications in consultation with the Indication Lead. Serve as medical point of contact for internal and external stakeholders; interact with investigators, respond to IRB/Health Authority questions, and present material to study executives and safety committees as applicable; train site staff at Investigator Meetings and CRA training for new indications. Ensure medical compliance with SOPs and GCP guidelines; collaborate with cross-functional team members to clearly communicate medical risks, issues, and results. In multi-physician protocols, appoint a primus inter pares to harmonize responses to site/IRB/RA inquiries and decisions on eligibility and protocol deviations. Keys to Success
Medical Doctor or equivalent degree required; board certification(s) preferred. Specialty training in neurology (residency/fellowship) with patient treatment and/or research experience. 1-3 years of industry experience in clinical development within Pharma, Biotech, or CRO settings. Neurologists with expertise in Pediatric Neurology or Neuromuscular diseases are highly preferred. Knowledge, Skills, Abilities
Excellent English communication skills (written and spoken) and ability to travel. Experience with NDA submission process and understanding of regulatory guidelines for adverse event reporting. Strong interpersonal and leadership skills to guide a study team and provide medical advice while escalating issues as needed. Proactive problem-solving, cross-cultural awareness, and strong matrix-management communication. Effective collaboration with cross-functional teams; ability to gather decision information, negotiate, and communicate decisions and actions clearly. Physical Requirements / Work Environment
Office environment with exposure to standard equipment; occasional site travel (domestic and international). Typically 6-8 hours stationary per day; ability to perform repetitive movements of hands/fingers; regular mobility; occasional crouching, bending, and twisting. Light to moderate lifting (up to 15-20 lbs); ability to use computer software; strong listening and communication abilities; ability to work independently and manage multiple tasks under changing conditions. Regular and consistent attendance and ability to work under stress and multi-task as needed. Benefits
Competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. The company supports an innovative, forward-thinking culture focused on integrity, intensity, involvement, and innovation.
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