Clinical Pharmacologist – Neurology, Immuno Oncology, Metabolic

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $135k - $138k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 0%

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 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.

📋 Description

• Participate in development, conduct, and reporting of global clinical trials for new compounds • Implement global clinical trials and report adverse events according to patient safety requirements • Review protocols, study reports, publications, data dissemination materials, labels, grant submissions, and contracts • Engage with regulatory and governmental agencies and external clinical customers, including thought leaders • Work with basic research scientists to identify lead compounds and plan preclinical studies • Support clinical pharmacology submission package planning with Business Unit teams • Serve as a scientific resource for study teams and departments • Ensure medical team activities comply with applicable regulations, GCPs, company standards, and policies • Develop clinical strategies and plans for compounds, including Phase 2 and 3 and biopharm submission plans • Collaborate with Global Patient Safety, PK/PD, ADME, Statistics, and Tailored Therapeutics teams • Design and oversee clinical pharmacology, biomarker qualification, and clinical research studies • Develop protocols and study conduct documents • Support investigator selection, study start-up, training, and site activities • Provide scientific support to trial managers, monitors, investigators, and ethics boards • Monitor patient safety and coordinate pharmacovigilance actions • Oversee third-party organizations supporting study execution • Address scientific questions from external healthcare professionals • Participate in clinical trial registry activities, data analysis, final reports, and publications • Present clinical trial results to corporate committees, regulatory agencies, and external organizations • Support publication strategies, symposia, advisory boards, and healthcare professional meetings • Prepare clinical reports and regulatory materials, including IND and Investigator Brochure medical sections • Support FDA advisory committee hearings, label discussions, and regulatory issue resolution • Develop scientifically excellent and innovative teams and organizational talent • Provide pre- and post-launch business customer support

🎯 Requirements

• Life science degree (MD, PhD, PharmD) with requisite experience in Clinical Pharmacology • PhD preferred but not required • Experience in Pharmaceutics and Product Design preferred • Knowledge of and experience in Clinical Pharmacology and the drug development process preferred • Fluent in English, both written and verbal • Interpersonal, organizational, and negotiation skills • Ability to influence others cross-functionally and within the function • Excellent teamwork skills • Willingness to engage in domestic and international travel • 3–5 years of clinical experience, or 3–5 years of pharmaceutical experience, including 2 years in clinical development • Alternatively, a BS or Master's degree in a health, medical, scientific, or related field and 7–10 years of directly related pharmaceutical experience • Clinical trial experience or experience relevant to drug discovery, drug/clinical development, epidemiology, toxicology, pharmacology, regulatory affairs, or medical affairs • Evidence of direct contribution to medical content, where applicable • Demonstrated ability to balance scientific and business priorities • Demonstrated communication, interpersonal, teamwork, organizational, and negotiation skills • Regular and consistent attendance • Ability to sit for extended periods and operate a vehicle safely • Ability to use various computer software • Ability to perform light to moderate lifting and carrying up to 15–20 lbs • Varied hours may be required

🏖️ Benefits

• Remote work arrangement • Domestic and international travel opportunities • EEO and accommodations support

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