Medical Director – Clinical Trial Physician, Pediatrics

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November 6

🌲 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 • 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 • 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 • Medical point of contact for all internal and external stakeholders • Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP • Closely collaborate with the cross functional study team members

🎯 Requirements

• Medical Doctor or equivalent degree required • Board certification(s) are preferred • Specialty education(e.g. residency/fellowship) required in pediatrics • 1-3 years of industry experience required • Experience should be in clinical development or medical monitoring in a Pharmaceutical, Biotech or CRO organization • Pediatricians with expertise in Pediatric Neurology, Rheumatology or Rare Disease 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. • A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and actions.

🏖️ Benefits

• We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.