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.Â
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.Â
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. Â
- Serve as the primary medical point of contact for investigators, study sites, CRO medical monitors, and internal cross-functional teams.Â
- Support safetymonitoringand pharmacovigilance activities, including review and medical input on adverse events, suspected unexpected serious adverse reactions, and other clinically significant safety findings.Â
- Collaboratewith internal and external stakeholders to design andimplementa clinical development plan across indications.Â
- Author key clinical trial documents and clinical sections of regulatory filings such as protocols, pre-INDs, IND/CTAs, Investigator Brochures, briefing documents, and BLAs.Â
- Collaborate cross-functionallywith clinical operations, regulatory, project management, manufacturing, and business development to define timelines, manage risks, and ensure milestone delivery.Â
- Work closely with translational sciences to integrate keybiomarkerand pharmacodynamic endpoints into clinical study designs.Â
- Establish andmaintainstrongrelationships with PIs,KOLs,and other external stakeholders.Â
- Review, assess, interpret,and communicate clinical trial data to internal stakeholders and external partners.Â
- Lead clinical trial data publication efforts.Â
- Lead or contribute to key external meetings such as advisory boards, safety review committees, investigatormeetings, and site trainings.Â
- Support quality initiatives related to clinical trial conduct,as needed.Â
Qualifications
- M.D., D.O., orequivalent. Board certification in medical oncologyorhematology preferred. Â
- A minimum of1year of experience in Clinical DevelopmentandPhase 1 - 3 oncology clinical trialsin a biotech or pharmaceutical setting, or equivalent.Â
Knowledge and Skills
- Proven experience advancing therapeutic programs in early or late-stage clinical development.Â
- Understanding of FDA and other health authority regulatory requirements and successfultrack recordin regulatory interactions.Â
- Demonstrated leadership and ability to effectively manage cross-functional teams.Â
- Excellent written and verbal communication skills, with the ability to communicate complex medical and scientific information clearly to diverse audiences.Â
- Strong organizational skills and ability to manage multiple studies, priorities, and timelines in a fast-paced biotech environment.Â
- High attention to detail, sound clinical judgment, and strong commitment to patient safety and data quality.Â
Washington State Pay Range - Associate Director: $287,887 - $333,496Â
Washington State Pay Range - Director: $342,540 - $394,941Â