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Director, Clinical Scientist

Full-time

Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Clinical Scientist based in the United States. As Director, Clinical Scientist, you will provide scientific and clinical leadership for the design, execution, and interpretation of oncology clinical trials. You will play a key role in advancing global clinical development programs targeting serious unmet medical needs, including innovative therapies for lung, colorectal, and bladder cancers. Working closely with Clinical Operations, Regulatory Affairs, Data Management, translational research teams, and external partners, you will help translate scientific insights into robust clinical strategies. You will oversee critical clinical and regulatory documentation, monitor data quality and safety trends, and support effective study enrollment and execution. This role offers the opportunity to influence clinical development decisions, build trusted relationships with investigators and research partners, and contribute to scientific communications across the medical community. Join a collaborative, fast-paced environment where scientific rigor, proactive problem-solving, and patient-focused research are central to advancing cancer treatment. Accountabilities - Lead Clinical Study Design: Drive or contribute to the design, refinement, and amendment of oncology clinical studies in collaboration with internal teams and external scientific stakeholders. - Develop Clinical and Regulatory Documentation: Partner with medical, regulatory, and cross-functional colleagues to author and review clinical protocols, protocol amendments, regulatory submissions, meeting packages, and other essential documentation.

- Oversee Clinical Data Quality: Collaborate with Clinical Operations, Data Management, and Contract Research Organizations (CROs) to establish and implement data quality plans, conduct internal medical data reviews, and identify emerging safety trends across assigned studies. - Provide Clinical Scientific Guidance: Serve as a key contact for clinical inquiries from CRO medical monitors and other stakeholders, providing scientific insight and helping resolve study-related questions. - Support Study Start-Up and Execution: Work with Clinical Operations and CRO partners to develop and maintain essential study resources, including informed consent forms, laboratory manuals, electronic data capture materials, and safety monitoring plans. - Monitor Patient Safety: Participate in safety review meetings and track, analyze, and review documentation relating to potential safety events, supporting appropriate evaluation and follow-up. - Drive Study Enrollment and Site Engagement: Build collaborative relationships with investigators, clinical site staff, CROs, and internal colleagues to support enrollment, address operational challenges, and facilitate effective study execution. - Develop Scientific Communications: Lead or contribute to communication strategies for ongoing and completed studies, including key opinion leader (KOL) engagement, advisory boards, medical congresses, publications, and scientific meetings. - Prepare Scientific Materials: Write and review abstracts, posters, presentations, meeting content, and other publicly distributed scientific materials, coordinating reviews and approvals with relevant internal stakeholders. - Coordinate Scientific Submissions: Manage submissions to scientific meetings, conferences, and other appropriate venues, ensuring materials are accurate, timely, and aligned with study objectives. - Interpret Clinical and Translational Data: Evaluate clinical findings alongside immunology and immuno-oncology translational data to inform study decisions, scientific communications, and broader development strategies.

Vacancy posted 4 days ago
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