Associate Director, Clinical Scientist, Internal Medicine (Cardio, Metabolic, & Renal)
Regeneron
3 months ago
On-site
Tarrytown, NY
Clinical Research and Development
Associate Director, Clinical Sciences
Responsibilities
- Lead the development, evaluation, planning, and execution of clinical studies; ensure scientific integrity and interpretation of clinical study data.
- Lead as Clinical Scientist for a program and/or as delegate of a Therapeutic Area Lead Clinical Scientist; participate in the Clinical Study Team and Global Clinical SubTeam.
- Contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; represent the function in cross-department collaborations.
- Maintain in-depth understanding of therapeutic disease areas and drug candidates (disease biology, clinical manifestations, standard of care, mechanism of action, and drug landscape).
- Propose, design, and complete clinical research and development studies for early and/or late-stage assets; develop strategy grounded in supporting literature.
- Develop Expanded Synopses; author clinically relevant protocol sections; review clinical trial protocols and amendments.
- Author and/or review trial-related documents (medical monitoring plans, statistical analysis plans, informed consents, and Clinical Study Report clinical components); support regulatory document development; perform quality review/approvals and resolve cross-functional comments.
- Ensure compliance with FDA, EMEA, ICH, and GCP guidelines and applicable SOPs regarding clinical safety.
- Lead planning and preparation for external/stakeholder meetings (e.g., IM, Governance, DMCs, Regulatory Authority); present data to external investigators and internal stakeholders.
- Perform clinical/medical data review including safety monitoring to ensure patient safety.
- Analyze how program objectives/design impact data analysis; identify risks and develop mitigation strategies.
- Standardize first-line clinical/medical data review techniques across studies/programs; review clinical data review plans and medical monitoring plans.
- Peer coach/mentor junior team members and provide guidance as appropriate.
Qualifications
- 10+ years of pharmaceutical clinical drug development experience.
- Experience managing clinical trials in one or more of: cardiovascular, renal, metabolic disease.
- Proficient knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology, and solid medical writing skills.
- Proficient knowledge of clinical development process, regulatory requirements, and ICH/GCP guidelines.
Skills/Preferred Traits
- Ability to lead in a matrix environment; professional diplomacy; influence across internal teams.
- Initiative, creativity, and innovation; experience driving process improvements.
- Strong cross-functional management, interpersonal, and problem-solving skills; proven track record in global clinical trials.
Benefits (as stated)
- U.S. benefits may include health and wellness programs (medical, dental, vision, life, disability insurance), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave).
Application Instructions
- Apply now to take your first step toward living the Regeneron Way.
Responsibilities
- Lead the development, evaluation, planning, and execution of clinical studies; ensure scientific integrity and interpretation of clinical study data.
- Lead as Clinical Scientist for a program and/or as delegate of a Therapeutic Area Lead Clinical Scientist; participate in the Clinical Study Team and Global Clinical SubTeam.
- Contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; represent the function in cross-department collaborations.
- Maintain in-depth understanding of therapeutic disease areas and drug candidates (disease biology, clinical manifestations, standard of care, mechanism of action, and drug landscape).
- Propose, design, and complete clinical research and development studies for early and/or late-stage assets; develop strategy grounded in supporting literature.
- Develop Expanded Synopses; author clinically relevant protocol sections; review clinical trial protocols and amendments.
- Author and/or review trial-related documents (medical monitoring plans, statistical analysis plans, informed consents, and Clinical Study Report clinical components); support regulatory document development; perform quality review/approvals and resolve cross-functional comments.
- Ensure compliance with FDA, EMEA, ICH, and GCP guidelines and applicable SOPs regarding clinical safety.
- Lead planning and preparation for external/stakeholder meetings (e.g., IM, Governance, DMCs, Regulatory Authority); present data to external investigators and internal stakeholders.
- Perform clinical/medical data review including safety monitoring to ensure patient safety.
- Analyze how program objectives/design impact data analysis; identify risks and develop mitigation strategies.
- Standardize first-line clinical/medical data review techniques across studies/programs; review clinical data review plans and medical monitoring plans.
- Peer coach/mentor junior team members and provide guidance as appropriate.
Qualifications
- 10+ years of pharmaceutical clinical drug development experience.
- Experience managing clinical trials in one or more of: cardiovascular, renal, metabolic disease.
- Proficient knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology, and solid medical writing skills.
- Proficient knowledge of clinical development process, regulatory requirements, and ICH/GCP guidelines.
Skills/Preferred Traits
- Ability to lead in a matrix environment; professional diplomacy; influence across internal teams.
- Initiative, creativity, and innovation; experience driving process improvements.
- Strong cross-functional management, interpersonal, and problem-solving skills; proven track record in global clinical trials.
Benefits (as stated)
- U.S. benefits may include health and wellness programs (medical, dental, vision, life, disability insurance), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave).
Application Instructions
- Apply now to take your first step toward living the Regeneron Way.