Senior Manager, Internal Medicine, Clinical Scientist (Immune/Inflammatory)
Regeneron
3 months ago
On-site
Tarrytown, NY
Clinical Research and Development
Responsibilities:
- Lead the development, evaluation, planning, and execution of clinical studies and ensure integrity and interpretation of study data for a clinical development program.
- Contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; participate in cross-functional collaborations.
- Develop/maintain expertise in therapeutic disease areas and drug candidates (disease biology, clinical manifestations, standard practice, mechanism of action, drug landscape).
- Support initiation and execution of early and/or late-stage clinical research and development studies; assist with the Expanded Synopsis and author/review clinically relevant protocol sections and amendments.
- Assist with and may author/review trial documents (medical monitoring plans, statistical analysis plans, informed consents, and clinical components of Clinical Study Reports); support regulatory document development and perform quality review.
- Maintain compliance with FDA, EMEA, ICH, and GCP guidelines and applicable SOPs regarding clinical safety.
- Perform clinical/medical data review including safety monitoring activities to ensure patient safety.
- Collaborate with internal functions and external vendors to promote clinical study integrity.
- Apply analytical skills to understand how study objectives/design impact data analysis; identify and mitigate critical risks.
- Promote consistent medical/clinical data review techniques across assigned studies; review clinical data review and medical monitoring plans.
Qualifications:
- BS/MS/PhD/PharmD in a related field.
- ≥ 8 years of pharmaceutical clinical drug development experience.
- Experience in one or more therapeutic areas, specifically Immune/Inflammatory related clinical trials.
Skills/Requirements:
- Ability to influence within and across teams; strong analytical and influencing skills.
- Strong communication and presentation skills; ability to communicate concise, clear messages.
- Ability to independently resolve complex issues using professional concepts and company objectives.
- Strong management, interpersonal, and problem-solving skills.
- Proven knowledge of the drug development process, Good Clinical Practice (GCP), study design, clinical research methodology, and medical writing; knowledge of regulatory requirements and ICH/GCP.
- Proven track record of clinical trial process improvements.
- Significant experience working cross-functionally and strong organizational awareness.
Benefits:
- In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees.
Application Instructions:
- Apply now to take your first step towards living the Regeneron Way.
- Lead the development, evaluation, planning, and execution of clinical studies and ensure integrity and interpretation of study data for a clinical development program.
- Contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; participate in cross-functional collaborations.
- Develop/maintain expertise in therapeutic disease areas and drug candidates (disease biology, clinical manifestations, standard practice, mechanism of action, drug landscape).
- Support initiation and execution of early and/or late-stage clinical research and development studies; assist with the Expanded Synopsis and author/review clinically relevant protocol sections and amendments.
- Assist with and may author/review trial documents (medical monitoring plans, statistical analysis plans, informed consents, and clinical components of Clinical Study Reports); support regulatory document development and perform quality review.
- Maintain compliance with FDA, EMEA, ICH, and GCP guidelines and applicable SOPs regarding clinical safety.
- Perform clinical/medical data review including safety monitoring activities to ensure patient safety.
- Collaborate with internal functions and external vendors to promote clinical study integrity.
- Apply analytical skills to understand how study objectives/design impact data analysis; identify and mitigate critical risks.
- Promote consistent medical/clinical data review techniques across assigned studies; review clinical data review and medical monitoring plans.
Qualifications:
- BS/MS/PhD/PharmD in a related field.
- ≥ 8 years of pharmaceutical clinical drug development experience.
- Experience in one or more therapeutic areas, specifically Immune/Inflammatory related clinical trials.
Skills/Requirements:
- Ability to influence within and across teams; strong analytical and influencing skills.
- Strong communication and presentation skills; ability to communicate concise, clear messages.
- Ability to independently resolve complex issues using professional concepts and company objectives.
- Strong management, interpersonal, and problem-solving skills.
- Proven knowledge of the drug development process, Good Clinical Practice (GCP), study design, clinical research methodology, and medical writing; knowledge of regulatory requirements and ICH/GCP.
- Proven track record of clinical trial process improvements.
- Significant experience working cross-functionally and strong organizational awareness.
Benefits:
- In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees.
Application Instructions:
- Apply now to take your first step towards living the Regeneron Way.