Senior Physician Scientist – Drug Regulatory Science

🔥 21 horas atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $166.000 - $206.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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RTI International

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1958

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

O RTI International é um instituto de pesquisa independente sem fins lucrativos dedicado a melhorar a condição humana através de soluções baseadas em ciência nas áreas de clima, educação, saúde e equidade. O instituto realiza pesquisas multidisciplinares que abrangem áreas diversas como cuidados de saúde, desenvolvimento internacional, ciências ambientais e justiça social e econômica. O RTI International colabora com uma vasta gama de parceiros, incluindo governos, empresas, universidades e organizações sem fins lucrativos, para conduzir pesquisas e fornecer serviços técnicos. O objetivo é impactar o bem-estar global, aproveitando a expertise em áreas como soluções para mudanças climáticas, reforma educacional, saúde pública, segurança alimentar e mais. O RTI International também enfatiza a responsabilidade corporativa, sustentabilidade e compromisso com a qualidade e ética em suas operações.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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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