Social Worker Care Manager – North Jersey
Ennoble Care
Senior Manager, Clinical Sciences, Internal Medicine
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
- Leads in the development, evaluation, planning and execution of clinical studies
- Ensures integrity and interpretation of study data of a clinical development program
- Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
- Participates in collaborative activities with other departments
- Develops/maintains understanding of therapeutic disease area(s) and drug candidate including underlying disease biology
- Applies basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late stage assets
- Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
- Collaborates with internal functions and external vendors to promote clinical study integrity
Requirements
- Bachelor’s Degree
- 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
- study design
- clinical research methodology & medical writing skills
- Knowledge of clinical development process
- regulatory requirements and ICH/GCP guidelines
- Proven track in clinical trial process improvements
- Experience in one or more of the following therapeutic areas - cardiovascular, renal, metabolic disease - preferred
Benefits
- health and wellness programs
- fitness centers
- equity awards
- annual bonuses
- paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchstudy designmedical writingclinical trial process improvementsdrug development processregulatory requirementsICH guidelinesGCP guidelinestherapeutic disease knowledgeclinical development process
Soft skills
leadershipcollaborationcommunicationorganizational skillsdata interpretationscientific expertiseteam contributionproblem-solvingadaptabilitystakeholder engagement
Certifications
Bachelor’s DegreePhDMDPharmDMScGood Clinical Practice certification
