Associate Director / Director, Clinical Development
Immunome, Inc.
August 29, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Position Overview
- Physician (Associate Director / Director, Clinical Development) providing medical and scientific oversight for oncology clinical studies.
Responsibilities
- Provide medical monitoring oversight for oncology clinical trials (safety events, eligibility questions, dose modifications, protocol deviations, lab abnormalities, emerging clinical data).
- Serve as primary medical point of contact for investigators, study sites, CRO medical monitors, and internal cross-functional teams.
- Support safety monitoring and pharmacovigilance (adverse events, suspected unexpected serious adverse reactions, clinically significant safety findings).
- Collaborate with internal/external stakeholders to design and implement clinical development plans across indications.
- Author key clinical trial documents and clinical sections of regulatory filings (protocols, pre-INDs, IND/CTAs, Investigator Brochures, briefing documents, BLAs).
- Partner cross-functionally (Clinical Operations, Regulatory, Project Management, Manufacturing, Business Development) to define timelines, manage risks, and ensure milestone delivery.
- Work with Translational Sciences to integrate biomarker and pharmacodynamic endpoints into study designs.
- Maintain relationships with PIs, KOLs, and external stakeholders; review/communicate clinical data.
- Lead clinical trial data publications.
- Lead or contribute to external meetings (advisory boards, safety review committees, investigator meetings, site trainings).
- Support quality initiatives as needed.
Qualifications
- M.D./D.O. (or equivalent); board certification in medical oncology or hematology preferred.
- Minimum 1 year experience in Clinical Development and Phase 1–3 oncology clinical trials in biotech/pharma (or equivalent).
Knowledge/Skills
- Experience advancing early/late-stage therapeutic programs.
- Knowledge of FDA/health authority regulatory requirements and regulatory interaction track record.
- Leadership managing cross-functional teams.
- Excellent written/verbal communication; strong organization and prioritization.
- Detail-oriented, sound clinical judgment, commitment to patient safety and data quality.
- Physician (Associate Director / Director, Clinical Development) providing medical and scientific oversight for oncology clinical studies.
Responsibilities
- Provide medical monitoring oversight for oncology clinical trials (safety events, eligibility questions, dose modifications, protocol deviations, lab abnormalities, emerging clinical data).
- Serve as primary medical point of contact for investigators, study sites, CRO medical monitors, and internal cross-functional teams.
- Support safety monitoring and pharmacovigilance (adverse events, suspected unexpected serious adverse reactions, clinically significant safety findings).
- Collaborate with internal/external stakeholders to design and implement clinical development plans across indications.
- Author key clinical trial documents and clinical sections of regulatory filings (protocols, pre-INDs, IND/CTAs, Investigator Brochures, briefing documents, BLAs).
- Partner cross-functionally (Clinical Operations, Regulatory, Project Management, Manufacturing, Business Development) to define timelines, manage risks, and ensure milestone delivery.
- Work with Translational Sciences to integrate biomarker and pharmacodynamic endpoints into study designs.
- Maintain relationships with PIs, KOLs, and external stakeholders; review/communicate clinical data.
- Lead clinical trial data publications.
- Lead or contribute to external meetings (advisory boards, safety review committees, investigator meetings, site trainings).
- Support quality initiatives as needed.
Qualifications
- M.D./D.O. (or equivalent); board certification in medical oncology or hematology preferred.
- Minimum 1 year experience in Clinical Development and Phase 1–3 oncology clinical trials in biotech/pharma (or equivalent).
Knowledge/Skills
- Experience advancing early/late-stage therapeutic programs.
- Knowledge of FDA/health authority regulatory requirements and regulatory interaction track record.
- Leadership managing cross-functional teams.
- Excellent written/verbal communication; strong organization and prioritization.
- Detail-oriented, sound clinical judgment, commitment to patient safety and data quality.