Director, Clinical Development - Oncology

Immunome, Inc.; Bothell (WA); On-site; USD 287,887 - 333,496; Full time

Job summary

Immunome, Inc. seeks an Associate Director/Director of Clinical Development to lead medical oversight across oncology programs in a fast‑paced environment in Bothell, WA.

You will partner with Clinical Operations, Biostatistics, Regulatory Affairs, and Translational Sciences to shape development plans and ensure patient safety. Responsibilities include protocol design, safety reviews, investigator engagement, and authoring regulatory documents.

Qualifications

• MD/DO or equivalent. Board certification in medical oncology or hematology preferred.
• Minimum 1 year of experience in Clinical Development and Phase 1–3 oncology trials in biotech/pharma.

Responsibilities

• Provide medical monitoring oversight for oncology trials, reviewing safety events, dose modifications, and protocol deviations.
• Serve as primary medical contact for investigators, sites, and internal teams.
• Support safety monitoring and pharmacovigilance activities, including AE review and signal detection.
• Collaborate to design and implement a clinical development plan across indications.
• Author clinical trial documents and regulatory submission materials.
• Work with cross-functional teams to define timelines and manage risks.
• Integrate biomarker endpoints into study designs with translational sciences.
• Build relationships with PIs, KOLs, and external stakeholders.
• Review and communicate trial data to stakeholders and partners.
• Lead clinical data publication efforts.
• Support external meetings and site trainings.
• Support quality initiatives related to trial conduct.

Skills

Regulatory knowledge

Cross-functional leadership

Scientific communication

Data/quality mindset

Education

MD/DO or equivalent

Job description

Immunome, Inc. seeks an Associate Director/Director of Clinical Development to lead medical oversight across oncology programs in a fast‑paced environment in Bothell, WA.

You will partner with Clinical Operations, Biostatistics, Regulatory Affairs, and Translational Sciences to shape development plans and ensure patient safety. Responsibilities include protocol design, safety reviews, investigator engagement, and authoring regulatory documents.