Associate Director, Clinical Scientist, Internal Medicine (Cardio, Metabolic, & Renal)
Regeneron
June 28, 2026
Remote friendly (Tarrytown, NY)
United States
Clinical Research and Development
Role Responsibilities:
- Lead development, evaluation, planning, and execution of clinical studies; ensure scientific integrity and interpretation of study data.
- Lead in a matrix, cross-functional environment; collaborate with Medical Director(s) to design and deliver clinical studies/programs.
- May serve as lead Clinical Scientist (or delegate of Therapeutic area Lead Clinical Scientist); member of Clinical Study Team and Global Clinical SubTeam.
- Contribute to program meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; represent function in cross-department collaboration.
- Maintain expert understanding of therapeutic disease areas, drug candidate biology, clinical manifestations, standards of care, mechanism of action, and drug landscape.
- Propose/design/complete early and late stage clinical research and development studies using supporting literature.
- Develop Expanded Synopsis; author clinically relevant sections; review clinical trial protocols and amendments.
- Author and/or review medical monitoring plans, SAPs, informed consents, and Clinical Study Report clinical components; support regulatory document development; perform quality review/approval and resolve cross-functional comments.
- Ensure compliance with FDA/EMEA/ICH/GCP and applicable SOPs regarding clinical safety.
- Lead planning and preparation for external/stakeholder meetings (IM, Governance, DMCs, Regulators); present to investigators and internal stakeholders.
- Perform clinical/medical data review including safety monitoring to ensure patient safety.
- Apply analytics to understand how objectives/design impact analysis; identify risks and develop mitigation strategies.
- Promote consistent data review techniques across studies/programs; review clinical data review plan and medical monitoring plan.
- Peer-coach/mentor junior team members as appropriate.
Qualifications/Experience:
- 10+ years of pharmaceutical clinical drug development experience.
- Experience managing clinical trials in cardiovascular, renal, and/or metabolic disease.
Required/Preferred Skills:
- Proficient knowledge of drug development process, Good Clinical Practice, study design, and clinical research methodology.
- Solid medical writing skills.
- Proficient knowledge of clinical development process, regulatory requirements, and ICH/GCP guidelines.
- Ability to lead in matrix environments; strong diplomacy and ability to influence.
- Initiative, creativity/innovation, and process improvement mindset.
- Proven global clinical trial leadership; strong cross-functional management and problem-solving.
Application Instructions:
- Apply now to take your first step toward living the Regeneron Way.
- Lead development, evaluation, planning, and execution of clinical studies; ensure scientific integrity and interpretation of study data.
- Lead in a matrix, cross-functional environment; collaborate with Medical Director(s) to design and deliver clinical studies/programs.
- May serve as lead Clinical Scientist (or delegate of Therapeutic area Lead Clinical Scientist); member of Clinical Study Team and Global Clinical SubTeam.
- Contribute to program meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; represent function in cross-department collaboration.
- Maintain expert understanding of therapeutic disease areas, drug candidate biology, clinical manifestations, standards of care, mechanism of action, and drug landscape.
- Propose/design/complete early and late stage clinical research and development studies using supporting literature.
- Develop Expanded Synopsis; author clinically relevant sections; review clinical trial protocols and amendments.
- Author and/or review medical monitoring plans, SAPs, informed consents, and Clinical Study Report clinical components; support regulatory document development; perform quality review/approval and resolve cross-functional comments.
- Ensure compliance with FDA/EMEA/ICH/GCP and applicable SOPs regarding clinical safety.
- Lead planning and preparation for external/stakeholder meetings (IM, Governance, DMCs, Regulators); present to investigators and internal stakeholders.
- Perform clinical/medical data review including safety monitoring to ensure patient safety.
- Apply analytics to understand how objectives/design impact analysis; identify risks and develop mitigation strategies.
- Promote consistent data review techniques across studies/programs; review clinical data review plan and medical monitoring plan.
- Peer-coach/mentor junior team members as appropriate.
Qualifications/Experience:
- 10+ years of pharmaceutical clinical drug development experience.
- Experience managing clinical trials in cardiovascular, renal, and/or metabolic disease.
Required/Preferred Skills:
- Proficient knowledge of drug development process, Good Clinical Practice, study design, and clinical research methodology.
- Solid medical writing skills.
- Proficient knowledge of clinical development process, regulatory requirements, and ICH/GCP guidelines.
- Ability to lead in matrix environments; strong diplomacy and ability to influence.
- Initiative, creativity/innovation, and process improvement mindset.
- Proven global clinical trial leadership; strong cross-functional management and problem-solving.
Application Instructions:
- Apply now to take your first step toward living the Regeneron Way.