Senior Director, Clinical Development bei Immunome, Inc.
Immunome, Inc. · Bothell, Vereinigte Staaten Von Amerika · Onsite
- Senior
- Optionales Büro in Bothell
Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.
Key Responsibilities:
- Lead and execute the clinical development strategy for novel oncology therapies.
- Collaborate with internal and external stakeholders to design and implement a clinical development plan across indications.
- Author/lead key clinical trial documents and clinical sections of regulatory filings such as pre-INDs and INDs.
- Serve as the primary Medical Monitor for assigned programs, including overseeing internal and external teams and providing medical guidance to CRO partners and clinical sites.
- Support safety monitoring and pharmacovigilance activities.
- 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.
- Facilitate key meetings such as advisory boards, safety review committees, investigator meetings.
Qualifications:
- M.D., D.O. or equivalent. Board certification in medical oncology or hematology preferred.
- A minimum of 2-4+ years of experience leading Clinical Development and Phase 1 – 3 oncology clinical trials in a biotech or pharmaceutical setting.
Knowledge and Skills
- Proven experience advancing therapeutic programs from IND-enabling studies through early and late-stage clinical development
- Understanding of FDA and EMA regulatory requirements and successful track record in regulatory interactions
- Demonstrated leadership and ability to effectively manage cross-functional teams
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
