Associate Director, Clinical Scientist, Ophthalmology
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, MADiscover your role:May function as Clinical Scientist for program, and/or as delegate of Therapeutic area Clinical ScientistContributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departmentsMaintains 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 landscapeUtilizes 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 literatureDevelops 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 supportContributes to planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal collaboratorsProficient analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategiesPromotes consistent first line medical/clinical data review techniques and conventions across studies/programs; Reviews clinical data review plan and authors ...