About this opportunity
Regeneron Pharmaceuticals, Inc (USA) lists this Associate Director, Clinical Scientist, Ophthalmology opportunity in village of tarrytown, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director to join our Clinical Scientist, Internal Medicine team supporting Ophthalmology. In this role, you will contribute to the development, evaluation, planning and execution of Internal Medicine clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Work in a matrix environment as part of a cross-functional team (with internal and external vendor representation) and may contribute to candidate development projects through early and/or late phase development. You will report to the Sr Dir/Director, Clinical Science, Internal Medicine and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where: Location: Tarrytown, NY, Warren, NJ, Cambridge, MA
Discover your role: May function as Clinical Scientist for program, and/or as delegate of Therapeutic area Clinical Scientist
Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
May represent function in collaborative activities with other departments
Maintains proficient understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape
Utilizes proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late-stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature
Develops the Expanded Synopsis and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments
Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve cross functional comments with minimal support
Contributes to planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal collaborators
Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis
Identifies risks and designs mitigation strategies
Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs
Reviews clinical data review plan and authors medical monitoring plan for assigned studies/program
This role requires:
A bachelor’s Degree required
Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/PharmD/MSc)
≥ 10 years of pharmaceutical clinical drug development experience, including basic knowledge of Ophthalmology
Proficient knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & demonstrates solid medical writing skills
Experience in all aspects of conducting global clinical trials and execution of clinical programs
Must self‑? 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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.