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Immunome, Inc. · 1 month ago

Senior Director, Clinical Development

Bothell, Washington, United States

Full-time

Onsite

Lead/Staff, Director/Executive

$343K/yr - $389K/yr

2+ years exp

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 seeking an accomplished Senior Director, Clinical Development to lead clinical strategy and execution within our innovative portfolio of ADC and radioligand therapies across all stages of development.

BiopharmaBiotechnologyMedicalPharmaceutical

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

Qualification

Clinical DevelopmentOncology TrialsRegulatory KnowledgeLeadershipCross-functional CollaborationMedical MonitorPharmacovigilanceData Publication

Required

M.D., D.O. or equivalent

A minimum of 2-4+ years of experience leading Clinical Development and Phase 1 – 3 oncology clinical trials in a biotech or pharmaceutical setting

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

Preferred

Board certification in medical oncology or hematology preferred

Company

Immunome, Inc.

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.

Founded in 2008

Exton, Pennsylvania, USA

51-200 employees