Manager, Internal Medicine, Clinical Scientist (Cardio, Metabolic, & Renal)
Regeneron
3 months ago
On-site
Tarrytown, NY
Clinical Research and Development
Role Responsibilities
- Lead the development, evaluation, planning, and execution of clinical studies; ensure integrity and interpretation of study data within a clinical development program.
- Contribute in a matrix environment as part of a cross-functional team; collaborate with Medical Director(s) to design and deliver clinical studies/programs.
- Participate in program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings.
- Develop/maintain expertise in therapeutic disease areas and drug candidates (disease biology, clinical manifestations, standard of care, mechanism of action, drug landscape).
- Support initiation and execution of early and/or late stage clinical research and development studies; assist with development of Expanded Synopsis; author/review clinically relevant protocol sections and amendments.
- Assist with and may author/review trial-related documents (medical monitoring plans, Statistical Analysis Plans, informed consents, Clinical Study Report clinical components); support regulatory document development and perform quality review.
- Maintain compliance with FDA, EMEA, ICH, and GCP guidelines and applicable SOPs for clinical safety.
- Perform clinical/medical data review including safety monitoring to ensure patient safety.
- Collaborate with internal functions and external vendors to promote clinical study integrity.
- Analyze how study objectives and design impact data analysis; identify critical risks and mitigations.
- Promote consistent first-line medical/clinical data review techniques; review clinical data review and medical monitoring plans for assigned studies.
Qualifications / Skills
- BS/MS/PhD/PharmD in a related field.
- 5+ years of pharmaceutical clinical drug development experience.
- Knowledge of drug development process, Good Clinical Practice (GCP), study design, clinical research methodology, and medical writing.
- Knowledge of clinical development process, regulatory requirements, and ICH/GCP guidelines; experience improving clinical trial processes.
- Strong analytical, communication, presentation, management, interpersonal, and problem-solving skills.
- Ability to influence within the team and cross-functionally; strong organizational awareness and cross-functional experience.
- Experience in one or more therapeutic areas: cardiovascular, renal, metabolic disease.
Benefits (if explicitly stated)
- In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, 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 towards living the Regeneron Way.
- Lead the development, evaluation, planning, and execution of clinical studies; ensure integrity and interpretation of study data within a clinical development program.
- Contribute in a matrix environment as part of a cross-functional team; collaborate with Medical Director(s) to design and deliver clinical studies/programs.
- Participate in program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings.
- Develop/maintain expertise in therapeutic disease areas and drug candidates (disease biology, clinical manifestations, standard of care, mechanism of action, drug landscape).
- Support initiation and execution of early and/or late stage clinical research and development studies; assist with development of Expanded Synopsis; author/review clinically relevant protocol sections and amendments.
- Assist with and may author/review trial-related documents (medical monitoring plans, Statistical Analysis Plans, informed consents, Clinical Study Report clinical components); support regulatory document development and perform quality review.
- Maintain compliance with FDA, EMEA, ICH, and GCP guidelines and applicable SOPs for clinical safety.
- Perform clinical/medical data review including safety monitoring to ensure patient safety.
- Collaborate with internal functions and external vendors to promote clinical study integrity.
- Analyze how study objectives and design impact data analysis; identify critical risks and mitigations.
- Promote consistent first-line medical/clinical data review techniques; review clinical data review and medical monitoring plans for assigned studies.
Qualifications / Skills
- BS/MS/PhD/PharmD in a related field.
- 5+ years of pharmaceutical clinical drug development experience.
- Knowledge of drug development process, Good Clinical Practice (GCP), study design, clinical research methodology, and medical writing.
- Knowledge of clinical development process, regulatory requirements, and ICH/GCP guidelines; experience improving clinical trial processes.
- Strong analytical, communication, presentation, management, interpersonal, and problem-solving skills.
- Ability to influence within the team and cross-functionally; strong organizational awareness and cross-functional experience.
- Experience in one or more therapeutic areas: cardiovascular, renal, metabolic disease.
Benefits (if explicitly stated)
- In the U.S., benefits may include health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, 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 towards living the Regeneron Way.