Senior Physician Scientist – Drug Regulatory Science

About the Hiring Group

RTI International is seeking a physician (MD) with expertise in FDA drug regulation, a strong understanding of Centers for Medicare & Medicaid Services (CMS) programs and policy, and a research background that includes experience synthesizing clinical evidence. This role offers a unique opportunity for a physician to lead work that directly shapes how clinical and regulatory evidence on drugs informs national Medicare drug policy, while helping to grow RTI's broader portfolio of drug-related evidence and policy work. The successful candidate will serve as a senior clinical and scientific leader providing clinical oversight and scientific direction for rapid evidence reviews of drugs, interpret FDA regulatory and labeling information, and translate complex clinical evidence into defensible, decision-ready products for federal policymakers. The position is expected to grow into a lead clinical role supporting new drug-policy work with CMS, FDA, and other HHS agencies. This position may be based in RTI's headquarters in Research Triangle Park, NC, or may be fully remote within the United States.

What You'll Do

• Serve as a senior clinical lead and scientific advisor supporting drug policy work, providing clinical oversight across evidence-related tasks for drug reviews.
• Provide scientific leadership for rapid comparative effectiveness reviews, including shaping protocols and scope, defining clinically meaningful outcomes, comparators, and subpopulations across multiple indications, and ensuring methods are rigorous while meeting compressed timelines.
• Conduct and oversee clinical review and quality control of deliverables, including study selection decisions, data extraction, risk-of-bias and quality assessment, evidence tables, unmet medical need analyses, and synthesis of findings.
• Interpret FDA labeling, approval history, and regulatory documents (e.g., NDA/BLA review packages, accelerated approval and confirmatory trial requirements, boxed warnings, REMS, postmarketing safety information), together with 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 ad hoc and 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, including identifying needed specialties, contributing to interview guides, and interpreting input from specialist clinicians on real-world treatment patterns and considerations in the use of drugs.
• Help design, test, and implement AI-enabled and automated approaches to evidence review workflows that improve efficiency while maintaining scientific quality.
• Lead tasks or subtasks of significant complexity on recurring annual cycles, anticipating client needs, planning staffing and workflows, and managing scope, schedule, budget, and client expectations.
• Contribute to proposals and to business development for new 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 including pharmacists, nurses, health economists, data analysts, policy analysts, and project leadership.
• Maintain strict confidentiality and comply with government regulatory agency conflict-of-interest, data security, and nondisclosure requirements.

Minimum Qualifications

• 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 (e.g., 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 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.
• To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status (e.g., H-1B visa status, etc.).

Preferred Qualifications

• 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 (e.g., systematic or rapid reviews, health technology assessments) and 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 of the District of Columbia.
• Advanced degree (e.g., 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 (e.g., DistillerSR, 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 (e.g., invited presentations, advisory or review panels).
• Experience supervising or mentoring staff, including overseeing research analysts and data analysts.