Senior Physician Scientist – Drug Regulatory Science

RTI International•Durham, NC

1d•$166,000 - $206,000•Remote

About The Position

RTI International is seeking a physician with expertise in FDA drug regulation, knowledge of CMS programs and policy, and experience synthesizing clinical evidence. The Senior Physician Scientist will provide senior clinical and scientific leadership for drug-policy work, including oversight and direction of rapid evidence reviews and interpretation of FDA regulatory and labeling information. The role translates complex clinical evidence into decision-ready products for federal policymakers and is expected to grow into a lead clinical role supporting drug-policy work with CMS, FDA, and other HHS agencies. The position may be based at RTI’s headquarters in Research Triangle Park, North Carolina, or may be fully remote within the United States. The role also involves leading complex recurring work, contributing to proposals and business development, mentoring staff, and collaborating with multidisciplinary teams while meeting government confidentiality, 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, such as Medicare Parts B and D, and 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 having no current or future financial relationships with pharmaceutical manufacturers.
Strong written and verbal communication skills, including experience translating complex clinical and regulatory information for diverse stakeholders such as policymakers.
Ability to collaborate in and lead interdisciplinary teams and manage multiple priorities in a fast-paced, client-directed environment.
U.S. citizenship or permanent resident status and a work location within the United States.
Must be legally authorized to work in the United States and must not require now or in the future employment visa sponsorship.

Nice To Haves

Completion of a medical residency in a specialty recognized by the American Board of Medical Specialties.
Experience critically appraising and synthesizing clinical trial and real-world evidence on drug effectiveness and safety, such as systematic or rapid reviews and health technology assessments, including 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 U.S. state or the District of Columbia.
Advanced degree such as an MPH, MS, or PhD 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 such as DistillerSR or Nested Knowledge, 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, such as invited presentations or advisory or review panels.
Experience supervising or mentoring staff, including overseeing research analysts and data analysts.

Responsibilities

Serve as a senior clinical lead and scientific advisor for drug-policy work, providing clinical oversight across evidence-related drug review tasks.
Provide scientific leadership for rapid comparative effectiveness reviews, including shaping protocols and scope, defining clinically meaningful outcomes, comparators, and subpopulations, and ensuring rigorous methods within compressed timelines.
Conduct and oversee clinical review and quality control of deliverables, including study selection, data extraction, risk-of-bias and quality assessment, evidence tables, unmet medical need analyses, and synthesis of findings.
Interpret FDA labeling, approval history, regulatory documents, drug compendia, and clinical practice guidelines to characterize indications, place in therapy, safety, off-label use, and therapeutic alternatives.
Develop and review clinical content for dossier-style deliverables, including clinical benefit summaries, place-in-therapy descriptions, special populations, and summaries of health technology assessments and systematic reviews.
Provide timely clinical consultation to government agencies and RTI project leadership, and support preparation of clinical materials for government meetings and briefings.
Guide clinical expert engagement by identifying needed specialties, contributing to interview guides, and interpreting specialist clinicians’ input on real-world treatment patterns and drug-use considerations.
Help design, test, and implement AI-enabled and automated evidence-review workflows that improve efficiency while maintaining scientific quality.
Lead complex tasks or subtasks on recurring annual cycles, anticipating client needs and managing staffing, workflows, scope, schedule, budget, and client expectations.
Contribute to proposals and business development for drug-related work with CMS, FDA, other HHS agencies, and state programs.
Mentor and provide clinical guidance to pharmacists, research analysts, and other staff, and collaborate with multidisciplinary teams.
Maintain strict confidentiality and comply with government regulatory agency conflict-of-interest, data-security, and nondisclosure requirements.