Associate Director, Clinical Scientist, Immunology

Regeneron Pharmaceuticals•Warren, MI

1d•Hybrid

About The Position

Regeneron is seeking an Associate Director to join its Clinical Scientist, Internal Medicine team supporting Immune/Inflammatory clinical development programs. The role contributes to the development, evaluation, planning, and execution of Internal Medicine clinical studies, ensuring scientific integrity and interpretation of study data across a clinical development program. The position works in a matrix environment with cross-functional teams, including internal and external vendors, and may contribute to candidate development projects in early- and/or late-phase development. It reports to the Sr Dir/Director, Clinical Science, Internal Medicine and collaborates closely with Medical Directors to provide scientific expertise for designing and delivering clinical studies and programs. The role may function as the Clinical Scientist for a program or as a delegate of the Therapeutic Area Clinical Scientist. It maintains therapeutic-area and drug-candidate knowledge and applies scientific expertise to clinical research and development. Responsibilities include developing and reviewing study documents, supporting regulatory documents and stakeholder meetings, presenting data, and contributing to clinical data review and risk mitigation.

Requirements

At least 10 years of pharmaceutical clinical drug development experience.
Proficient knowledge of the drug development process, Good Clinical Practice, study design, and clinical research methodology.
Solid medical writing skills.
Experience in all aspects of conducting global clinical trials and executing clinical programs.
Strong teamwork skills and the ability to demonstrate confidence and professional diplomacy when relating to people at all levels internally and externally.
Demonstrated ability to influence within a team and potentially influence cross-functionally in a matrix organization.

Nice To Haves

Advanced degree or equivalent education/degree in life science or healthcare, such as a PhD, PharmD, or MSc (preferred).
Experience in Immunology clinical trials.

Responsibilities

May function as Clinical Scientist for a program and/or as delegate of the Therapeutic Area Clinical Scientist.
Contribute to program team meetings, scientific advisory boards, study steering committees, and data/safety monitoring meetings; represent the function in collaborative activities with other departments as appropriate.
Maintain a proficient understanding of therapeutic disease areas and drug candidates, including disease biology, clinical manifestations, standard therapeutic practice, mechanisms of action, and the drug landscape.
Use scientific expertise to propose, design, and execute clinical research and development studies for early- and/or late-stage assets; develop and communicate strategy proposals grounded in supporting literature.
Develop the Expanded Synopsis; author clinically relevant sections and review other scientific portions of clinical trial protocols and amendments.
Author and/or review trial-related documents, including medical monitoring plans, SAPs, informed consents, and clinical components of Clinical Study Reports; support regulatory-document development, perform quality review, and potentially approve documents; adjudicate and resolve cross-functional comments with minimal support.
Contribute to planning and prepare information for external and stakeholder meetings, including IM, Governance, DMC, and Regulatory Authority meetings.
Present data and information to external investigators at SIVs and to internal collaborators.
Apply analytical knowledge to understand how program objectives and study design affect data analysis; identify risks and develop mitigation strategies.
Promote consistent first-line medical/clinical data review techniques and conventions across studies and programs.
Review clinical data review plans and author medical monitoring plans for assigned studies or programs.

Benefits

Annual bonuses or other incentive plans may be offered, depending on country and role.
Equity awards may be offered, depending on country and role.
Pension or retirement benefits may be offered, depending on country and role.
401(k) company match may be offered, depending on country and role.
Health and wellness programs may be offered, depending on country and role.
Fitness centers may be available, depending on country and role.
Insurance benefits, including medical, dental, vision, life, and disability coverage, may be offered, depending on country and role.
Paid time off may be offered, depending on country and role.
Family support benefits may be offered, depending on country and role.
Competitive and comprehensive total rewards package.