Clinical Scientist (Manager), Translational Science and Medicine (TSM)-Immunology

About the role

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

Responsibilities

• Support the execution of clinical trial protocols of the clinical development plan, ensuring compliance with scientific, organizational, and regulatory standards.
• End-to-end delivery of clinical trial protocols, including study design, initiation, medical data monitoring, data dissemination, and closeout activities.
• Co-manage and coordinate trial activities with internal, cross-functional and external partners to ensure timely execution of clinical trials and to ensure the quality and integrity of data.
• Support providing training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes.
• Support the review, interpretation, and reporting of clinical trial data, assisting with ensuring 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).
• Contribute to the medical data monitoring activities in partnership with the Study Responsible Physician, including the evaluation, documentation, and reporting of ongoing clinical trial data per defined medical data review plan.
• Contribute to process improvements and implementation of best practices in clinical trial execution.
• Collaborate with cross-functional partners to support clinical strategies with overall product development goals.
• Contributes to the preparation and presentation of the results of clinical research in internal department/management meetings. May also support the preparation of materials for external expert engagements.
• Develop and maintain relationships with internal and external stakeholders, including senior management, cross-functional trial teams, and external partners/vendors (e.g. CRO).

Requirements

• A minimum of a bachelor’s degree with a scientific background in Immunology or a related field is required. An advanced degree (e.g., MS, PharmD, PhD) is preferred.
• A scientific background in Gastroenterology is preferred.
• Requires at least 3-5 years of relevant experience in clinical research and development within the pharmaceutical industry, biotech, CRO, or equivalent.
• Experience with Ph 0, 1 and 2a studies in immunology indications is preferred.
• Understanding clinical development processes, including trial design, protocol development, data analysis, regulatory guidelines, Good Clinical Practice (ICH GCP), and study execution.
• Proven the ability to interpret scientific literature and apply findings strategically within clinical projects.
• Proficiency in Microsoft Office Suite, especially Excel, Word, and PowerPoint, and familiarity with generative artificial intelligence and clinical trial management software is advantageous.
• Excellent written and verbal communication skills; ability to effectively present information to the stakeholders.
• Strong interpersonal skills with a collaborative approach to working within cross-functional and global matrix teams.
• Strong organizational skills with the ability to multi-task and prioritize assignments.
• Prowen analytical and problem-solving capabilities, with a detail-oriented mindset.
• Ability to proactively identify study level issues/discussions that require escalation.
• Ability to handle study projects to overcome delays and obstacles to meet deadlines.
• Strong project and time management skills.
• Willingness to travel domestically and internationally, approximately 10%, as required by project needs.

Qualifications

• Absolutely no qualifications listed.