Senior Clinical Scientist, Immunology Programs

Regulatory Jobs; Village of Tarrytown (NY); Presencial; USD 176.000 - 287.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to join the Clinical Scientist, Internal Medicine team supporting Immune/Inflammatory development programs.

You will contribute to development, evaluation, planning and execution of internal medicine clinical studies and ensure data integrity and interpretation across programs. Location includes Tarrytown, NY with hybrid flexibility; primarily on-site.

Formación

• Advanced degree with medical writing and data interpretation skills.
• Strong understanding of clinical trial design and regulatory expectations.
• Experience in Immunology clinical trials is preferred.

Responsabilidades

• 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.

Conocimientos

Clinical Scientist

Study design

Medical writing

Team collaboration

Educación

Advanced degree in life science/healthcare (PhD/PharmD/MSc)

Descripción del empleo

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to join the Clinical Scientist, Internal Medicine team supporting Immune/Inflammatory development programs.

You will contribute to development, evaluation, planning and execution of internal medicine clinical studies and ensure data integrity and interpretation across programs. Location includes Tarrytown, NY with hybrid flexibility; primarily on-site.