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, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets.
Position summary:
We are seeking an accomplished Senior Director, Clinical Development to join our passionate and collaborative team and drive the advancement of our pipeline of targeted cancer therapies. In this high-impact role, you will lead clinical strategy and execution within our innovative portfolio of ADC and radioligand therapies across all stages of development.
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.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).
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