Associate Director, Medical Writing
GlobeNewswire
Google Cloud Platform
Senior Manager, Clinical Scientist – Oncology
Regeneron
full-time
Posted on:
Location: 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 oncology programs
- 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 early/late phase candidate development projects
- Report to the Associate 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, drug candidates and mechanism of action
- Support initiation and execution of clinical research and development studies; author or review protocol sections, amendments and related trial documents
- Assist with or author medical monitoring plans, SAPs, informed consents, clinical components of Clinical Study Reports and regulatory documents; may perform quality review
- Maintain compliance with FDA, EMEA, ICH and GCP guidelines and applicable SOPs
- Perform clinical/medical data review including safety monitoring and patient safety activities
- Identify critical risks and mitigations and review clinical data review plans and medical monitoring plans
Requirements
- Bachelor’s Degree required; Advanced degree (PhD/MD/PharmD/MSc) preferred
- ≥ 8 years of pharmaceutical clinical drug development experience
- Proven knowledge of the drug development process
- Knowledge of Good Clinical Practice (GCP) and ICH guidelines
- Experience with study design, clinical research methodology & medical writing skills
- Knowledge of regulatory requirements
- Proven track record in clinical trial process improvements
- Considerable organizational awareness and significant cross-functional experience
- Strong analytical, influencing, presentation, management, interpersonal and problem-solving skills
- Ability to influence within team and may influence across functions
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