Associate Director, Clinical Scientist, Oncology
Regeneron
7 hours ago
Remote friendly (Warren, NJ)
United States
Clinical Research and Development
Associate Director, Clinical Sciences (Oncology Clinical Development)
Responsibilities:
- Lead the development, evaluation, planning, and execution of clinical studies; ensure scientific integrity and interpretation of clinical data.
- Serve as lead Clinical Scientist for a program and/or delegate of a Therapeutic area Lead Clinical Scientist.
- 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 knowledge of disease area(s), drug candidate, underlying biology, clinical manifestations, therapeutic standards, mechanism of action, and drug landscape; ensure compliance with FDA/EMEA/ICH/GCP and applicable SOPs.
- Propose, design, and execute early and/or late-stage clinical research and development studies; develop strategy proposals grounded in literature.
- Develop Expanded Synopsis and author/review clinically relevant protocol sections and amendments.
- Author and/or review trial documents (medical monitoring plans, SAPs, informed consents, CSR clinical components) and support regulatory document development; perform quality review/approval as appropriate; adjudicate and resolve cross-functional comments.
- Plan and prepare materials for external/stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); present data to external investigators (SIV) and internal stakeholders.
- Perform clinical/medical data review, including safety monitoring activities to ensure patient safety.
- Analyze how program objectives/design affect data analysis; identify risks and develop mitigation strategies.
- Promote consistent medical/clinical data review techniques; review clinical data review plan and medical monitoring plan for assigned studies/programs.
Qualifications & Required/Preferred Skills:
- Bachelor’s degree; advanced degree or equivalent in life science/healthcare preferred (PhD/MD/PharmD/MSc).
- 10+ years of pharmaceutical clinical drug development experience.
- Proven leadership experience in conducting global clinical trials and executing clinical programs.
- Strong cross-functional management, interpersonal, and problem-solving skills.
- Proficient knowledge of clinical development process, regulatory requirements, and ICH/GCP.
- Ability to lead in a matrix environment; confidence and professional diplomacy; influence within and across functions.
- Initiative, creativity, innovation; ability to resolve novel problems.
- Experience mentoring/peer coaching and guiding junior team members.
Benefits (explicitly mentioned):
- Comprehensive benefits varying by location; U.S. benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves.
Application instructions:
- “Apply now to take your first step towards living the Regeneron Way!”
Responsibilities:
- Lead the development, evaluation, planning, and execution of clinical studies; ensure scientific integrity and interpretation of clinical data.
- Serve as lead Clinical Scientist for a program and/or delegate of a Therapeutic area Lead Clinical Scientist.
- 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 knowledge of disease area(s), drug candidate, underlying biology, clinical manifestations, therapeutic standards, mechanism of action, and drug landscape; ensure compliance with FDA/EMEA/ICH/GCP and applicable SOPs.
- Propose, design, and execute early and/or late-stage clinical research and development studies; develop strategy proposals grounded in literature.
- Develop Expanded Synopsis and author/review clinically relevant protocol sections and amendments.
- Author and/or review trial documents (medical monitoring plans, SAPs, informed consents, CSR clinical components) and support regulatory document development; perform quality review/approval as appropriate; adjudicate and resolve cross-functional comments.
- Plan and prepare materials for external/stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); present data to external investigators (SIV) and internal stakeholders.
- Perform clinical/medical data review, including safety monitoring activities to ensure patient safety.
- Analyze how program objectives/design affect data analysis; identify risks and develop mitigation strategies.
- Promote consistent medical/clinical data review techniques; review clinical data review plan and medical monitoring plan for assigned studies/programs.
Qualifications & Required/Preferred Skills:
- Bachelor’s degree; advanced degree or equivalent in life science/healthcare preferred (PhD/MD/PharmD/MSc).
- 10+ years of pharmaceutical clinical drug development experience.
- Proven leadership experience in conducting global clinical trials and executing clinical programs.
- Strong cross-functional management, interpersonal, and problem-solving skills.
- Proficient knowledge of clinical development process, regulatory requirements, and ICH/GCP.
- Ability to lead in a matrix environment; confidence and professional diplomacy; influence within and across functions.
- Initiative, creativity, innovation; ability to resolve novel problems.
- Experience mentoring/peer coaching and guiding junior team members.
Benefits (explicitly mentioned):
- Comprehensive benefits varying by location; U.S. benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves.
Application instructions:
- “Apply now to take your first step towards living the Regeneron Way!”