Associate Director / Director, Clinical Science
Immunome, Inc.Bothell, Washington, United States · Posted 7 days agoDescription
Company Overview
Position Overview
Immunome is seeking a highly experienced and strategic Associate Director / Director, Clinical Science to provide scientific leadership for clinical development programs across our oncology portfolio. This role will be responsible for shaping clinical strategy, authoring and reviewing key clinical documents, and ensuring scientific rigor in the design, conduct, analysis, and interpretation of clinical studies.
The successful candidate will bring deep expertise in oncology drug development, strong cross-functional leadership in a matrix organization, and the communication skills required to translate complex clinical data into clear recommendations. This position offers a highly visible opportunity to influence clinical development plans and help advance Immunome’s innovative targeted therapies.
Responsibilities
Strategic Leadership
- Partner with Clinical Development leadership to define clinical strategy and contribute to integrated clinical development plans for assigned programs.
- Provide scientific leadership for clinical study design (Phase 1–3), including endpoints, eligibility criteria, dose and regimen rationale, and biomarker strategy.
- Serve as a key clinical development voice in program governance, enabling timely, data-driven decisions that balance patient safety, scientific value, and development timelines.
Program Oversight and Execution
- Lead the scientific execution of clinical studies, collaborating with Clinical Operations, Data Management, Biostatistics, Clinical Pharmacology, Translational Medicine, and Safety to ensure high-quality conduct.
- Support medical monitoring activities, including review of safety data, protocol deviations, and emerging risk/benefit considerations, in partnership with Medical Directors and Pharmacovigilance.
- Review and interpret clinical data (safety, efficacy, PK/PD, biomarkers), generate insights, and communicate results to internal teams and external stakeholders.
Vendor and Partner Management
- Provide clinical development oversight of CROs and vendors (e.g., central labs, imaging, biomarkers) to ensure alignment with protocol requirements and data quality expectations.
- Collaborate with external investigators, steering committees, and key opinion leaders to support study execution, recruitment, and scientific communication.
Regulatory and Documentation Support
- Author, review, and contribute to clinical protocols, amendments, investigator brochures, informed consent forms, statistical analysis plans (in partnership), clinical study reports, and regulatory submissions (IND/CTA, annual reports, briefing packages).
- Contribute to responses to health authority questions and support regulatory interactions by providing clear clinical development rationale and data interpretation.
- Ensure all clinical development activities comply with GCP, applicable regulations, and internal quality standards.
Leadership and Collaboration
- Lead, mentor, and develop clinical scientists and/or contractors, fostering a culture of scientific excellence, accountability, and collaboration.
- Drive alignment across cross-functional teams, proactively identifying risks, proposing mitigation plans, and ensuring clear communication of priorities and decisions.
- Support scientific dissemination through abstracts, manuscripts, presentations, and investigator meeting materials.
Qualifications
- PhD, PharmD, MD, or equivalent advanced degree in a life science discipline with 5+ years of experience in clinical development (oncology preferred).
- Demonstrated experience designing and executing oncology clinical trials, including protocol development, endpoint selection, and operational feasibility considerations.
- Proven track record authoring and reviewing key clinical documents and contributing to regulatory submissions and/or health authority interactions.
- Experience interpreting clinical and translational data (safety, efficacy, PK/PD, biomarkers) and presenting findings to diverse audiences.
- Strong understanding of ICH/GCP and global clinical development regulations and guidance.
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