Associate Director, Clinical Scientist, Immunology

Regeneron Pharmaceuticals

3d • $176,100 - $287,300 • 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 and helps ensure the scientific integrity and interpretation of study data across a clinical development program. The Associate Director works in a matrixed, cross-functional environment that includes internal teams and external vendors, and may contribute to candidate development projects in early- and/or late-phase development. The position reports to the Sr Dir/Director, Clinical Science, Internal Medicine and collaborates closely with Medical Directors to provide scientific expertise for the design and delivery of clinical studies and programs.

The role may serve as the Clinical Scientist for a program or as a delegate of the Therapeutic Area Clinical Scientist. It requires proficient knowledge of the relevant therapeutic disease area, candidate, disease biology, clinical manifestations, standards of care, mechanisms of action, and drug landscape. The Associate Director proposes, designs, and executes clinical research and development studies; contributes to study and program strategy; authors and reviews trial and regulatory-related documents; supports data review and risk mitigation; and prepares and presents information for internal and external stakeholders.

The position is based in Tarrytown, New York; Warren, New Jersey; or Cambridge, Massachusetts. The work model is primarily on-site with hybrid flexibility. The annual salary range is $176,100 to $287,300. A competitive total rewards package may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits, depending on country and role.

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 relate professionally to people at all levels, internally and externally.
• Demonstrated ability to influence within a team and potentially cross-functionally in a matrix organization.
• Advanced degree or equivalent education/degree in life science or healthcare; examples include PhD, PharmD, or MSc.

Nice To Haves

• Experience in Immunology clinical trials.
• Advanced life science or healthcare degree, such as a PhD, PharmD, or MSc.

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; may represent the function in collaborative activities with other departments.
• Maintain a proficient understanding of therapeutic disease areas and drug candidates, including disease biology, clinical manifestations, therapeutic standards of practice, compound 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, and communicate strategy proposals grounded in supporting literature.
• Develop the Expanded Synopsis and author clinically relevant sections of clinical trial protocols and amendments; review other scientific portions of these documents.
• Author and/or review trial-related documents, including medical monitoring plans, SAPs, informed consents, and clinical components of Clinical Study Reports; support development of regulatory documents, 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, DMCs, and Regulatory Authorities.
• Present data and information to external investigators at SIVs and to internal collaborators.
• Apply analytical knowledge to understand how program objectives and design affect data analysis; identify risks and design mitigation strategies.
• Promote consistent first-line medical and 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

• Competitive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits; offerings depend on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior