Immunology Clinical Scientist Leader – Associate Director

Regeneron Pharmaceuticals; Cambridge; On-site; GBP 132,000 - 216,000; Full time

Job summary

Regeneron Pharmaceuticals seeks an Associate Director to join the Clinical Scientist, Internal Medicine team supporting Immune/Inflammatory development programs. You will help design and execute clinical studies, ensuring data integrity and scientific rigor across early and late phases.

Responsibilities include leading program meetings, contributing to data interpretation, and authoring critical trial documents while collaborating with internal MDs and external vendors.

Qualifications

• Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/PharmD/MSc)
• ≥ 10 years of pharmaceutical clinical drug development experience.
• Experience in Immunology clinical trials preferred
• 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
• We need an individual who is a strong team-player; Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally; Demonstrated ability to Influence within team and may influence cross functionally in a matrix organization

Responsibilities

• 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

Skills

Advanced degree

Life science

Clinical drug development

Immunology experience

Good Clinical Practice

Education

PhD/PharmD/MSc

Job description

Regeneron Pharmaceuticals seeks an Associate Director to join the Clinical Scientist, Internal Medicine team supporting Immune/Inflammatory development programs. You will help design and execute clinical studies, ensuring data integrity and scientific rigor across early and late phases.

Responsibilities include leading program meetings, contributing to data interpretation, and authoring critical trial documents while collaborating with internal MDs and external vendors.