Senior Manager, Clinical Scientist, Translational Science & Medicine-Immunology

Senior Manager, Clinical Science

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Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

The Clinical Science group within Translational Science & Medicine (TSM) is seeking a Senior Manager, Clinical Scientist based in Spring House, PA, Cambridge, MA, La Jolla, CA, or Leiden, The Netherlands to support the design, development and execution of early clinical development and experimental medicine studies within the Immunology Therapeutic Area.

We are seeking a highly motivated clinical scientist with a BS, MS, PharmD, PhD, or RN degree, relevant pharmaceutical or biotechnology industry experience, and preferably a background in Immunology, Rheumatology or a related scientific discipline. The role requires a solid understanding of clinical development, clinical trial documentation, regulatory requirements, and operational processes. The successful candidate will thrive in a collaborative, matrixed environment and possess a passion for advancing transformational therapies from early development through proof of concept and beyond.

Position Summary

The Senior Manager, Clinical Science provides active scientific and strategic contributions and is responsible for contributing to the execution of Phase 0, Phase 1(b), and Phase 2a clinical studies within the Therapeutic Area. This position involves collaborating with cross-functional teams, in close partnership with Study Responsible Physicians/Clinical Leads, to design, plan, and manage complex clinical trials, ensuring compliance with departmental, company, and regulatory standards.

This role assists in contributing to the clinical development plan, is involved in the development of clinical trial protocols and materials and supports the completion of clinical study reports and regulatory filings. As a core member of the clinical team, the Senior Manager manages matrix interactions among cross-functional members, assists with contributing to the evaluation of scientific opportunities, medical data monitoring, and drives process improvements to enhance trial efficiency and operational excellence.

This role may manage direct reports, mentor colleagues, and foster a culture of continuous learning and development within the team.

Essential Job Duties and Responsibilities

• Contribute to the development and execution of clinical trial strategies and other study-related materials (e.g. case report forms, operational plans) and provide clinical representation for study-related review committees (e.g., protocol review committee).
• Contribute to the execution of clinical strategies for clinical trial protocols, ensuring compliance with scientific, organizational, and regulatory standards.
• Oversee end-to-end delivery of a clinical trial protocol, including study design, initiation, medical data monitoring, data dissemination, and closeout activities.
• Contribute to the management and coordination of activities with internal functional partners and external partners to ensure timely scientific and clinical execution of a clinical trial.
• Contributes to the maintenance of the quality and integrity of clinical data, which is critical to the evaluation of study endpoints.
• Support interaction and collaboration with investigators and study teams during the conduct of the trial(s). Lead training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes.
• Contribute to the review, interpretation, and reporting of clinical trial data, supporting accuracy and integrity for health authority submissions.
• Contribute to the preparation of documents for reporting clinical trial data (e.g., clinical study reports, patient narratives, investigator brochures, and periodic safety updates).
• Collaborate with Study Responsible Scientist and Study Responsible Physician to assess and evaluate clinical trial data (i.e. adverse events, labs, medications, etc.). Establish and define medical data review plan in partnership with Study Responsible Physician. Performs medical data monitoring/reporting and evaluates ongoing clinical trial data.
• In partnership with Study Responsible Physician, act as a liaison between the company and clinical investigators, fostering collaborations with key opinion leaders and external advisors.
• Develop and maintain relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO, ARO).
• Contribute to mentorship and training of junior team members, fostering a collaborative work environment.
• Actively engage in opportunities to enhance clinical development and therapeutic area expertise.
• Identify opportunities for process…