Senior Physician Scientist – Drug Regulatory Science

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🔥 1 hour ago

🇺🇸 United States – Remote

💵 $166k - $206k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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RTI International

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1958

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

RTI International is an independent nonprofit research institute dedicated to improving the human condition through science-based solutions in climate, education, health, and equity. The institute engages in multidisciplinary research spanning diverse areas such as health care, international development, environmental sciences, and social and economic justice. RTI International collaborates with a wide range of partners including governments, businesses, universities, and non-profit organizations to conduct research and provide technical services. It aims to impact global wellbeing by leveraging expertise in fields such as climate change solutions, education reform, public health, food security, and more. RTI International also emphasizes corporate responsibility, sustainability, and commitment to quality and ethics in its operations.

📋 Description

• Serve as a senior clinical lead and scientific advisor supporting drug policy work • Provide clinical oversight across evidence-related tasks for drug reviews • Lead rapid comparative effectiveness reviews, including protocols, scope, outcomes, comparators, and subpopulations • Conduct and oversee clinical review and quality control of deliverables • Make study selection decisions, perform data extraction, risk-of-bias and quality assessment, develop evidence tables, analyze unmet medical needs, and synthesize findings • Interpret FDA labeling, approval history, and regulatory documents alongside drug compendia and clinical practice guidelines • Characterize indications, place in therapy, safety, off-label use, and therapeutic alternatives • Develop and review clinical content for dossier-style deliverables • Provide timely clinical consultation to government agencies and RTI project leadership • Prepare clinical materials for government meetings and briefings • Guide clinical expert engagement and interpret specialist clinician input • Help design, test, and implement AI-enabled and automated evidence review workflows • Lead complex recurring tasks while planning staffing and workflows and managing scope, schedule, budget, and client expectations • Contribute to proposals and business development for drug-related work with CMS, FDA, HHS agencies, and state programs • Mentor pharmacists, research analysts, and other staff • Collaborate with multidisciplinary teams including pharmacists, nurses, health economists, data analysts, policy analysts, and project leadership • Maintain confidentiality and comply with government conflict-of-interest, data security, and nondisclosure requirements

🎯 Requirements

• Doctor of Medicine (MD or DO) or equivalent medical degree • At least 8 years of relevant experience beyond clinical education and training in U.S.-related regulatory science, health policy, health services research, government, or healthcare consulting • At least 5 years of current or past clinical practice • Demonstrated experience with FDA regulations, processes, and guidance for drugs and/or biologics, including interpretation of labeling and regulatory review documents • Working knowledge of CMS programs and policies related to drug coverage and payment, including Medicare Parts B and D • Familiarity with the Inflation Reduction Act of 2022 and its Medicare prescription drug provisions • Ability to provide input and consultation across a broad range of therapeutic areas and indications • Demonstrated experience leading projects or major tasks and contributing to successful proposals • Ability to meet client conflict-of-interest requirements, including no current or future financial relationships with pharmaceutical manufacturers • Strong written and verbal communication skills, with experience translating complex clinical and regulatory information for diverse stakeholders, including policymakers • Proficiency collaborating in and leading interdisciplinary teams and managing multiple priorities in a fast-paced, client-directed environment • U.S. citizenship or permanent resident status and work location within the U.S. • Legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status • Completion of a medical residency in a specialty recognized by the American Board of Medical Specialties • Demonstrated experience critically appraising and synthesizing clinical trial and real-world evidence on drug effectiveness and safety • Experience with meta-analysis, risk-of-bias assessment, and certainty-of-evidence frameworks such as GRADE • Board certification in a clinical specialty recognized by the American Board of Medical Specialties; oncology specialization is a plus • Active, unrestricted medical license in a US state or the District of Columbia • Advanced degree in epidemiology, health services research, health policy, or a related field • Prior experience working at or directly supporting FDA, CMS, or other HHS agencies • Hands-on experience conducting systematic reviews, drug class reviews, or health technology assessments • Experience with formulary management, pharmacy and therapeutics committees, payer medical policy, or coverage decision-making • Experience using AI-enabled or automated evidence synthesis tools and large language models • Experience working with Medicare or Medicaid claims data, FDA data, or other large federated health care datasets • Track record of peer-reviewed publications and external recognition • Experience supervising or mentoring staff, including overseeing research analysts and data analysts

🏖️ Benefits

• Generous paid time off policy • Merit based annual increases • Bonus opportunities • Robust recognition program • Health insurance • Dental insurance • Life insurance • Short-term disability insurance • Long-term disability insurance • Retirement savings program such as a 401(k) plan • Paid parental leave for all parents • Financial assistance with adoption expenses or infertility treatments • Financial reimbursement for education and developmental opportunities • Employee assistance program • Other offerings to support a healthy work-life balance

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