
10,000+ employees
🏥 Healthcare
🧬 Biotechnology
đź’Š Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
🔥 2 hours ago
🇺🇸 United States – Remote
đź’µ $130k - $190k / year
⏰ Full Time
đźź Senior
đź”´ Lead
đź§Ş Clinical Research
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10,000+ employees
🏥 Healthcare
🧬 Biotechnology
đź’Š Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
• Provide ongoing in-depth analysis and scientific input into development and execution of protocols and clinical development plans • Work with the medical/scientific/regulatory team to solve medical, scientific, clinical, and regulatory problems • Serve as a resource for the Medical Monitor by tracking and reviewing study-specific safety data to identify safety trends • Act as liaison among the Medical Monitor, study sites, Fortrea project staff, and Sponsors regarding protocol and study-related questions • Document, track, and follow up on study-related issues • Review and evaluate CPS proposals and provide clinical and scientific support • Draft study outlines and designs and provide guidance on early clinical development strategies • Establish and maintain affiliations with the Fortrea and larger scientific community • Provide rationale and input for including biomarkers or other lab markers in Proof-of-Concept studies • Attend Kick-off Meetings, SIVs/Investigator Meetings, and Team Meetings • Support training in key medical/scientific areas • Ensure medical and safety issues discussed in team meetings are resolved by the Medical Monitor • Support CPS Medical Monitors in tracking and documenting Inclusion/Exclusion criteria and protocol-related questions and answers • Perform other related duties as assigned
• Doctor of Medicine (MD) degree required • Prior hands-on experience as licensed physician (MD) in clinical practice • 2+ years prior hands-on experience as a licensed physician in clinical practice preferred • TA-specific experience in Hereditary Angioedema (HAE) is required • Progressive responsibility within CRO or Sponsor environment • Knowledge of GCPs and regulatory agency guidelines • Ability to conduct limited review of related literature and references and apply the information • Skilled in data interpretation • English speaking, writing, and reading • Minimum 10+ years pharmaceutical and clinical research experience, including at least 5+ years in a medical monitoring/medical data review role • Heavy travel required throughout the year • Must be authorized to work in the United States on a full-time basis • Company does not provide visa sponsorship now or in the future
• Medical insurance • Dental insurance • Vision insurance • Life insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(K) • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable
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