Manager, Clinical Scientist, Hematology
Regeneron
11 hours ago
Remote friendly (Warren, NJ)
United States
Clinical Research and Development
Discover Your Role:
- Member of the Clinical Study Team and Global Clinical sub-team; contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; represent the function in cross-department collaborations.
- Develop/maintain understanding of therapeutic disease areas and drug candidate (disease biology, clinical manifestations, standard practice, mechanism of action, and drug landscape).
- Apply basic scientific expertise to support initiation and execution of early and/or late-stage clinical research and development studies.
- Assist with development of the Expanded Synopsis; may author/ review clinically relevant protocol sections and amendments.
- Assist with and may author/review trial documents (medical monitoring plans, SAPs, informed consents, and Clinical Study Report clinical components); may support regulatory document development; may perform quality review.
- Maintain compliance with FDA, EMEA, ICH, and GCP guidelines and applicable SOPs for clinical safety.
- Prepare for external/stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); present data to external investigators (SIV) and internal collaborators.
- Influence within the team and across functions; strong analytical, influencing, communication, and presentation skills.
This Role Requires:
- Bachelor’s degree required; advanced degree preferred (PhD/MD/PharmD/MSc) in life science/healthcare.
- 3+ years of pharmaceutical clinical drug development experience.
- Basic knowledge of oncology or hematology therapeutic areas; track record in clinical trial process improvements.
- Proven leadership in global clinical trials and execution of clinical programs.
- Proficient knowledge of clinical development processes, regulatory requirements, and ICH/GCP; resolves novel problems.
Benefits (U.S., if applicable): health and wellness programs, 401(k) match, equity awards, annual bonuses, paid time off, and paid leaves (varies by location).
Application: “Does this sound like you? Apply now to take your first step towards living the Regeneron Way!”
- Member of the Clinical Study Team and Global Clinical sub-team; contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; represent the function in cross-department collaborations.
- Develop/maintain understanding of therapeutic disease areas and drug candidate (disease biology, clinical manifestations, standard practice, mechanism of action, and drug landscape).
- Apply basic scientific expertise to support initiation and execution of early and/or late-stage clinical research and development studies.
- Assist with development of the Expanded Synopsis; may author/ review clinically relevant protocol sections and amendments.
- Assist with and may author/review trial documents (medical monitoring plans, SAPs, informed consents, and Clinical Study Report clinical components); may support regulatory document development; may perform quality review.
- Maintain compliance with FDA, EMEA, ICH, and GCP guidelines and applicable SOPs for clinical safety.
- Prepare for external/stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); present data to external investigators (SIV) and internal collaborators.
- Influence within the team and across functions; strong analytical, influencing, communication, and presentation skills.
This Role Requires:
- Bachelor’s degree required; advanced degree preferred (PhD/MD/PharmD/MSc) in life science/healthcare.
- 3+ years of pharmaceutical clinical drug development experience.
- Basic knowledge of oncology or hematology therapeutic areas; track record in clinical trial process improvements.
- Proven leadership in global clinical trials and execution of clinical programs.
- Proficient knowledge of clinical development processes, regulatory requirements, and ICH/GCP; resolves novel problems.
Benefits (U.S., if applicable): health and wellness programs, 401(k) match, equity awards, annual bonuses, paid time off, and paid leaves (varies by location).
Application: “Does this sound like you? Apply now to take your first step towards living the Regeneron Way!”