Associate Director / Director, Clinical Development

Immunome, Inc.•Bothell, WA

1d•$287,887 - $394,941

About The Position

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. 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.

Requirements

M.D., D.O., or equivalent.
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.
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.

Nice To Haves

Board certification in medical oncology or hematology preferred.

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/CTAs, 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.