Medical Director - Clinical Trial Physician, Neurology

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July 18

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

🔔 Pennsylvania – Remote

Although this job is listed in Pennsylvania, this company may be open to hiring remote in other states.

+4 more states

🌲 North Carolina – Remote 🔔 Pennsylvania – Remote 🌴 South Carolina – Remote 🎸 Tennessee – Remote ⚔️ Virginia – Remote ⛰️ West Virginia – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Thermo Fisher Scientific

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Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Provides clear medical leadership in the Study team, • working in close collaboration with the other members of this cross functional team, • in order to provide reliable, high quality study data within time and budget. • Provide medical leadership to the study teams, • including creating clinical trial protocols while implementing the latest scientific information, • contribute to site selection, • contribute to 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: • ensure medical validity of each individual primary endpoint as well study subject safety, • while ensuring medical issues are identified early. • Pro-active escalation and correction of issues in consultation with the Global Medical Indication Lead. • Interpret the clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, • in consultation with the Indication Lead. • Medical point of contact for all internal and external stakeholders: • Interact with the investigators as needed, • answer questions of IRBs and Health Authorities, • prepare and present material to the study executive and independent safety committee if applicable; • medical training of site staff at Investigator meetings; • CRA training in new indications. • Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP.

🎯 Requirements

• Medical Doctor or equivalent degree required. • Board certification(s) are preferred. • Specialty education(e.g. residency/fellowship) required in neurology. • Patient treatment and/or research experience. • 1-3 years of industry experience required. • Experience should be in clinical development in a Pharmaceutical, Biotech or CRO organization. • Neurologists with expertise in Pediatric Neurology or Neuromuscular diseases are highly preferred. • Excellent English, both written and spoken is a must, as well as ability to travel. • Shown understanding and experience with NDA submission process. • Shown understanding of regulatory guidelines for adverse event reporting. • Proven interpersonal skills enabling to lead a study team, • while recognizing individual expert competencies, • providing medical advice and evaluations exercising judgment in which issues need to be escalated immediately. • Pro-active problem solver with negotiation skills, • remaining sensitive to the different cultural needs in a global organization. • Strong communication skills to ensure close collaboration with the cross functional team members so that study plans and status are transparent, • and that risks, issues, and results are clear to all involved parties.

🏖️ Benefits

• We offer competitive remuneration, • annual incentive plan bonus, • healthcare, • a range of employee benefits. • Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, • and outstanding career and development prospects. • We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!