Lead Clinical Scientist, Hematology/Oncology

Regeneron Pharmaceuticals, Inc.; Warren (MI); Hybrid; USD 176,000 - 287,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director, Clinical Sciences for Hematology/Oncology, to lead design and execution of clinical studies across all phases in a matrixed environment.

The role partners with Medical Directors to develop study plans, write and review protocols, and manage medical monitoring plans, while mentoring scientists and driving data integrity and risk mitigation across programs.

Qualifications

• Advanced degree in life science or healthcare and 10+ years of clinical drug development experience.
• Proven leadership in conducting global clinical trials and programs.
• Knowledge of drug development process, GCP, study design, and clinical research methods.
• Solid medical writing skills and cross-functional management abilities.

Responsibilities

• Lead or support clinical science strategy for a program as Lead Clinical Scientist or delegate to the Therapeutic Area Lead.
• Partner with Medical Directors to design and deliver clinical studies grounded in disease biology, the drug landscape, and current literature.
• Develop the Expanded Synopsis and author or review clinical sections of protocols, amendments, and study reports.
• Prepare medical monitoring plans, SAPs, and informed consents, and resolve cross-functional comments with minimal guidance.
• Lead planning for and present at program team meetings, advisory boards, steering committees, DMCs, regulatory authority meetings, and investigator meetings.
• Promote consistent clinical data review practices across studies, and identify risks and design mitigation strategies.
• Manage and mentor clinical scientists and junior colleagues, serving as a peer coach.
• Influence across functions with confidence, creativity, and professional diplomacy while driving process improvements.

Skills

Leadership

Global clinical trials

Drug development knowledge

Medical writing

Interpersonal skills

Education

Advanced life science/healthcare degree (PhD/MD/PharmD/MSc)

Job description

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director, Clinical Sciences for Hematology/Oncology, to lead design and execution of clinical studies across all phases in a matrixed environment.

The role partners with Medical Directors to develop study plans, write and review protocols, and manage medical monitoring plans, while mentoring scientists and driving data integrity and risk mitigation across programs.