Associate Director / Director, Clinical Development

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

Associate Director / Director, Clinical Development

Bothell, Washington, United States

Company Overview

Immunome is a clinical‑stage targeted oncology company committed to developing first‑in‑class and best‑in‑class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting‑edge therapies, including antibody‑drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM‑1021, a clinical‑stage ROR1 ADC; IM‑3050, an IND‑cleared FAP‑targeted radiotherapy; and IM‑1617, an IND‑cleared solid tumor ADC. We are also advancing a broad portfolio of early‑stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

We are seeking a highly motivated physician to join Immunome as Associate Director/Director, Clinical Development, supporting the development of our investigational oncology pipeline. This individual will provide medical and scientific oversight for clinical studies and serve as a key member of the Clinical Development team, partnering closely with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, Medical Writing, and Translational Sciences.

The Associate Director/Director will be responsible for supporting protocol design and implementation, patient safety oversight, medical monitoring of ongoing trials, investigator and site engagement, medical review of emerging safety and efficacy data, and contribution to regulatory and scientific interactions. This position offers an opportunity to play a meaningful role in shaping the clinical development strategy for novel therapies addressing significant unmet needs in oncology.

Responsibilities

• Provide medical monitoring oversight for oncology clinical trials, including review of safety events, eligibility questions, dose modifications, protocol deviations, laboratory abnormalities, and emerging clinical data.
• Serve as the primary medical point of contact for investigators, study sites, CRO medical monitors, and internal cross‑functional teams.
• Support safety monitoring and pharmacovigilance activities, including review and medical input on adverse events, suspected unexpected serious adverse reactions, and other clinically significant safety findings.
• Collaborate with internal and external stakeholders to design and implement a clinical development plan across indications.
• Author key clinical trial documents and clinical sections of regulatory filings such as protocols, pre‑INDs, IND/CTA, Investigator Brochures, briefing documents, and BLAs.
• Collaborate cross‑functionally with clinical operations, regulatory, project management, manufacturing, and business development to define timelines, manage risks, and ensure milestone delivery.
• Work closely with translational sciences to integrate key biomarker and pharmacodynamic endpoints into clinical study designs.
• Establish and maintain strong relationships with PIs, KOLs, and other external stakeholders.
• Review, assess, interpret, and communicate clinical trial data to internal stakeholders and external partners.
• Lead clinical trial data publication efforts.
• Lead or contribute to key external meetings such as advisory boards, safety review committees, investigator meetings, and site trainings.
• Support quality initiatives related to clinical trial conduct, as needed.

Qualifications

• M.D., D.O., or equivalent. Board certification in medical oncology or hematology preferred.
• A minimum of 1 year of experience in Clinical Development and Phase 1–3 oncology clinical trials in a biotech or pharmaceutical setting, or equivalent.

Knowledge and Skills

• Proven experience advancing therapeutic programs in early or late‑stage clinical development.
• Understanding of FDA and other health authority regulatory requirements and successful track record in regulatory interactions.
• Demonstrated leadership and ability to effectively manage cross‑functional teams.
• Excellent written and verbal communication skills, with the ability to communicate complex medical and scientific information clearly to diverse audiences.
• Strong organizational skills and ability to manage multiple studies, priorities, and timelines in a fast‑paced biotech environment.
• High attention to detail, sound clinical judgment, and strong commitment to patient safety and data quality.

Washington State Pay Range - Associate Director: $287,887 - $333,496

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.