Associate Director, Immunology Clinical Scientist

Regeneron Pharmaceuticals, Inc; Cambourne; Sur place; GBP 105 000 - 143 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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

Connaissances

Teamwork

Diplomacy

Cross-functional influence

Formation

PhD/PharmD/MSc in life sciences

Description du poste

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.