Associate Director, Clinical Scientist, Immunology

Regeneron Pharmaceuticals, Inc; Cambourne; On-site; GBP 105,000 - 143,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to lead clinical science activities within the Internal Medicine team, supporting Immunology programs.

You will contribute to the design, evaluation, planning and execution of clinical studies while ensuring data integrity and robust interpretation of results. You will collaborate in a matrix environment with internal and external partners, prepare regulatory documents, and support external meetings with investigators and stakeholders.

Qualifications

• Advanced life science degree preferred.
• 10+ years of pharmaceutical clinical drug development experience.
• Experience in Immunology clinical trials preferred.
• Knowledge of GCP, trial design, and medical writing recommended.

Responsibilities

• May function as Clinical Scientist for program 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.
• 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/program; Reviews clinical data review plan and authors medical monitoring plan for assigned studies/program

Skills

Teamwork

Diplomacy

Cross-functional influence

Education

PhD/PharmD/MSc in life sciences

Job description

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 Immune/Inflammatory clinical development programs. 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, MA

Work Model: Primarily On-site with hybrid flexibility

Discover your role:

• 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

This role requires:

• 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