Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first- 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.)
In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025.
Position Overview
The Director, Pathology will develop and implement comprehensive plans to support optimal nonclinical packages for candidate drugs in all stages of development from developing liability assessments and advising on early screening assays to submission of NDA/BLAs.
In this role, they will lead the design, development, and implementation of discovery, interpretation of target expression, and exploratory pathology plans for multiple oncology programs, enabling the optimal clinical development of candidate drugs.
This role reports to the Executive Director, Toxicology.
Responsibilities
Act as a pathology and pathogenesis subject matter expert in Translational Sciences, providing key strategy and analysis cross-functionally for discovery, target expression interpretation, and animal models.
Provide pathology support for exploratory and development (e.g.
GLP) pathology endpoints on internal and external in vivo studies across the pipeline.
Provide expert authorship and/or review of regulatory submissions (e.g.
INDs, IBs, CTDs, BLAs).
Executes on the plans to provide high quality data to support internal decision making and regulatory submissions.
Actively partners with other functions and departments to ensure that programs are progressed seamlessly through the development process.
Participates in assessment of in-license assets to provide a recommendation to senior management.
Represents the function at internal and external meetings, providing clear assessment of data to communicate the potential and value of pipeline assets.
Actively participates in functional meetings.
Qualifications
Board-certified in veterinary pathology (ACVP/ECVP) required.
Ph.D., PharmD, MD, or equivalent in a relevant scientific discipline (e.g.
biology, toxicology).
4+ years' experience, preferably with large molecule experience.
Global regulatory filing (NDA/BLA) experience preferred.
Knowledge and Skills
Experience with designing and reporting out exploratory pathology studies.
Experience developing and qualifying/validating comparative biomarker assays.
Experience authoring relevant sections of global regulatory submissions and interacting with global health authorities.
Excellent skills in assessment of the appropriate toxicology experiments to support clinical development at all stages of product development.
Demonstrated experience supporting regulatory compliant nonclinical development plans, with excellent working knowledge of the regulatory process.
Engagement in cutting edge technologies which improve decision making and align with regulatory partners.
Excellent problem-solving skills and ability and desire to oversee multiple projects simultaneously in a fast-paced environment.
Demonstrated experience in leading cross-functional teams in the development and execution of biomarker and diagnostics plans to support preclinical and clinical development.
Outstanding interpersonal and communication skills (written and oral) with ability to communicate complex information succinctly.
Experience with developing, leading, and executing translational strategies, such as the transition from discovery research into clinical development.
Ability to drive collaboration, achieve results, influence, and resolve conflicts across internal and external project 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.
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