Senior Physician Scientist – Drug Regulatory Science

RTI International

. Serve as a senior clinical lead and scientific advisor supporting drug policy work .

Posted 11/9/2026full-timeRemote • United StatesSenior💰 $166,000 - $206,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in clinical oversight, regulatory science, and health policy, with a strong focus on drug effectiveness and safety evaluations. Proven ability to lead interdisciplinary teams, manage complex projects, and provide strategic clinical consultation to government agencies.

Highest-signal resume keywords

Doctor Of Medicine (MD Or DO)FDA Regulations And GuidanceClinical Practice ExperienceSystematic Reviews And Meta-AnalysisBoard Certification In Clinical Specialty

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical OversightData ExtractionRisk-Of-Bias AssessmentEvidence SynthesisClinical Trial AppraisalTherapeutic Area ConsultationFormulary ManagementAI-Enabled Evidence SynthesisQuality Control Of DeliverablesClinical Content Development

Soft Skills

Strong Written And Verbal CommunicationLeadership And MentoringCollaboration In Interdisciplinary TeamsClient Relationship ManagementProject Management

Tools & Technologies

Automated Evidence Review WorkflowsLarge Language ModelsHealth Technology Assessment ToolsMedicare Claims DataFDA Data

Certifications & Qualifications

Board Certification In Clinical SpecialtyActive Medical License In The U.S.Completion Of Medical Residency

Industry Keywords

Regulatory ScienceHealth PolicyDrug Coverage And PaymentMedicare Parts B And DInflation Reduction Act Of 2022Health Services ResearchPharmacy And Therapeutics CommitteesPeer-Reviewed PublicationsGovernment AgenciesHealthcare Consulting

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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