Senior Physician Scientist – Drug Regulatory Science

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the senior clinical lead and scientific advisor for drug policy initiatives.

• Provide clinical oversight for tasks related to evidence in drug evaluations.

• Lead rapid comparative effectiveness reviews, including the development of protocols, defining scopes, outcomes, comparators, and subpopulations.

• Conduct and supervise clinical reviews and quality assurance of deliverables.

• Make decisions on study selection, execute data extraction, assess risk-of-bias and quality, create evidence tables, analyze unmet medical needs, and synthesize findings.

• Interpret FDA labeling, approval histories, regulatory documents, drug compendia, and clinical practice guidelines.

• Characterize indications, therapeutic positioning, safety profiles, off-label uses, and alternative therapies.

• Develop and review clinical content for dossier-style submissions.

• Provide timely clinical consultations to government entities and RTI project leads.

• Prepare clinical materials for government meetings and briefings.

• Facilitate clinical expert engagement and analyze insights from specialist clinicians.

• Assist in the design, testing, and implementation of AI-enabled and automated evidence review workflows.

• Manage complex recurring tasks while planning staffing and workflows, overseeing scope, schedule, budget, and client expectations.

• Contribute to proposals and business development efforts related to drug work with CMS, FDA, HHS agencies, and state programs.

• Mentor pharmacists, research analysts, and other team members.

• Collaborate with multidisciplinary teams, including pharmacists, nurses, health economists, data analysts, policy analysts, and project leaders.

• Maintain confidentiality and adhere to government conflict-of-interest, data security, and nondisclosure regulations.

⛳️ Requirements

• A Doctor of Medicine (MD or DO) or equivalent medical degree is required.

• A minimum of 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 prior clinical practice experience.

• Proven experience with FDA regulations, processes, and guidance for drugs and/or biologics, including the interpretation of labeling and regulatory review documents.

• Familiarity with CMS programs and policies concerning drug coverage and payment, including Medicare Parts B and D.

• Knowledge of the Inflation Reduction Act of 2022 and its provisions regarding Medicare prescription drugs.

• Ability to provide expert input and consultation across a wide range of therapeutic areas and indications.

• Demonstrated experience in leading projects or significant tasks and contributing to successful proposals.

• Capacity to meet client conflict-of-interest requirements, including having no current or future financial relationships with pharmaceutical manufacturers.

• Excellent written and verbal communication skills, with experience in translating complex clinical and regulatory information for diverse stakeholders, including policymakers.

• Proficient in collaborating with and leading interdisciplinary teams while managing multiple priorities in a fast-paced, client-oriented environment.

• U.S. citizenship or permanent resident status, with a work location within the U.S.

• Legally authorized to work in the United States, without the need for current or future employment visa sponsorship.

• Completion of a medical residency in a specialty recognized by the American Board of Medical Specialties is essential.

• Demonstrated experience in critically appraising and synthesizing clinical trial and real-world evidence regarding 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 an advantage.

• Active, unrestricted medical license in a U.S. state or the District of Columbia.

• An advanced degree in epidemiology, health services research, health policy, or a related field is preferred.

• Previous experience working at or directly supporting FDA, CMS, or other HHS agencies is beneficial.

• Practical experience in conducting systematic reviews, drug class reviews, or health technology assessments.

• Experience with formulary management, pharmacy and therapeutics committees, payer medical policies, or coverage decision-making processes.

• Experience utilizing AI-enabled or automated evidence synthesis tools and large language models.

• Familiarity with Medicare or Medicaid claims data, FDA data, or other large federated health care datasets.

• A record of peer-reviewed publications and external recognition.

• Experience in supervising or mentoring staff, including overseeing research analysts and data analysts.

🏝️ Benefits

• Generous paid time off policy.

• Merit-based annual increases.

• Bonus opportunities.

• Comprehensive recognition program.

• Health insurance coverage.

• Dental insurance coverage.

• Life insurance coverage.

• Short-term disability insurance coverage.

• Long-term disability insurance coverage.

• Retirement savings program, such as a 401(k) plan.

• Paid parental leave for all parents.

• Financial assistance for adoption expenses or infertility treatments.

• Financial reimbursement for education and professional development opportunities.

• Employee assistance program.

• Additional offerings to promote a healthy work-life balance.