Associate Director / Director, Clinical Development
Immunome, Inc.
August 07, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Position Overview: Associate Director/Director, Clinical Development (oncology). Provide medical and scientific oversight for clinical studies and partner with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Medical Writing, and Translational Sciences.
Responsibilities:
- Provide medical monitoring oversight for oncology clinical trials (safety events, eligibility, dose modifications, protocol deviations, lab abnormalities, emerging data).
- Serve as primary medical point of contact for investigators, 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 to design and implement a clinical development plan across indications.
- Author key clinical trial/regulatory documents (protocols, pre-INDs, IND/CTAs, Investigator Brochures, briefing documents, BLAs).
- Cross-functionally define timelines, manage risks, and ensure milestone delivery.
- Integrate biomarker and pharmacodynamic endpoints into clinical study designs with Translational Sciences.
- Establish/maintain relationships with PIs, KOLs, and external stakeholders.
- Review, interpret, and communicate clinical trial data; lead clinical trial publication efforts.
- 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 Clinical Development experience and Phase 1–3 oncology clinical trials in biotech/pharma (or equivalent).
Knowledge/Skills:
- Experience advancing therapeutic programs in early/late-stage development.
- Understanding of FDA/health authority regulatory requirements and successful regulatory interactions.
- Leadership; manage cross-functional teams.
- Excellent written/verbal communication of complex medical/scientific information.
- Strong organization; manage multiple studies in fast-paced biotech.
- Detail-oriented clinical judgment; strong commitment to patient safety and data quality.
Responsibilities:
- Provide medical monitoring oversight for oncology clinical trials (safety events, eligibility, dose modifications, protocol deviations, lab abnormalities, emerging data).
- Serve as primary medical point of contact for investigators, 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 to design and implement a clinical development plan across indications.
- Author key clinical trial/regulatory documents (protocols, pre-INDs, IND/CTAs, Investigator Brochures, briefing documents, BLAs).
- Cross-functionally define timelines, manage risks, and ensure milestone delivery.
- Integrate biomarker and pharmacodynamic endpoints into clinical study designs with Translational Sciences.
- Establish/maintain relationships with PIs, KOLs, and external stakeholders.
- Review, interpret, and communicate clinical trial data; lead clinical trial publication efforts.
- 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 Clinical Development experience and Phase 1–3 oncology clinical trials in biotech/pharma (or equivalent).
Knowledge/Skills:
- Experience advancing therapeutic programs in early/late-stage development.
- Understanding of FDA/health authority regulatory requirements and successful regulatory interactions.
- Leadership; manage cross-functional teams.
- Excellent written/verbal communication of complex medical/scientific information.
- Strong organization; manage multiple studies in fast-paced biotech.
- Detail-oriented clinical judgment; strong commitment to patient safety and data quality.