Senior Manager, Clinical Scientist – Hematology
Regeneron
full-time
Posted on:
Location Type: Hybrid
Location: Tarrytown • New York • 🇺🇸 United States
Visit company websiteSalary
💰 $148,300 - $241,900 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Lead development, evaluation, planning and execution of clinical studies for hematology
- Ensure integrity and interpretation of study data of a clinical development program
- Lead in a matrix environment as part of a cross-functional team and contribute to candidate development projects (early and/or late phase)
- Report to Director, Clinical Sciences and collaborate closely with Medical Director(s)
- Contribute to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
- Member of the Clinical Study Team and Global Clinical SubTeam
- Develop/maintain understanding of therapeutic disease areas and drug candidates including biology, clinical manifestations and therapeutic standard practice
- Support initiation and execution of clinical research and development studies; author/review protocol sections, amendments, medical monitoring plans, SAPs, informed consents and clinical components of Clinical Study Reports
- Perform clinical/medical data review, including safety monitoring and activities to ensure patient safety
- Maintain compliance with FDA, EMEA, ICH and GCP guidelines and applicable SOPs
- Support identification of critical risks and mitigations and promote consistent medical/clinical data review techniques
Requirements
- Bachelor’s Degree (minimum)
- Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc)
- ≥ 8 years of pharmaceutical clinical drug development experience
- Proven knowledge of the drug development process
- Good Clinical Practice (GCP) and ICH guidelines knowledge
- Study design and clinical research methodology
- Medical writing skills
- Knowledge of regulatory requirements
- Proven track in clinical trial process improvements
- Significant experience working cross-functionally
- Strong analytical, influencing, presentation, management, interpersonal and problem-solving skills
Benefits
- inclusive and diverse culture
- comprehensive benefits, which often include (depending on location) health and wellness programs
- fitness centers
- equity awards
- annual bonuses
- paid time off for eligible employees at all levels
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical study designclinical research methodologymedical writingdata reviewsafety monitoringprotocol authoringclinical trial process improvementsregulatory requirements knowledgedrug development process knowledgeclinical components of Clinical Study Reports
Soft skills
analytical skillsinfluencing skillspresentation skillsmanagement skillsinterpersonal skillsproblem-solving skills
Certifications
Bachelor’s DegreePhDMDPharmDMSc