Associate Director, DMPK

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.) 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 ADC with an active IND, and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. 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.

Position Overview

The Associate Director, DMPK will develop and implement comprehensive plans to support optimal nonclinical pharmacokinetics/ADME packages for candidate drugs in all stages of research and development. In this role, they will lead the design, development, and implementation of DMPK plans for multiple oncology programs, enabling the optimal clinical development of candidate drugs. This role reports to the Executive Director, ADME.

Responsibilities

• Proactively develops plans to provide stage specific data for all assets from research through regulatory submission for drug approval. Executes on 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 and efficiently through the development process.
• Represents the function at internal and external meetings, providing clear assessment of timelines, data, and impact to pipeline assets, including complex visualizations, to effectively communicate.
• Represents ADME function on project teams.
• Collaborates with Research project teams and within Translational Sciences/Development teams.
• Designs PK, TK, and PKPD studies, analyzes data, and conducts modeling and simulation, Interprets and translates data.
• Manages CROs for outsourced studies.
• Authors nonclinical pharmacokinetics sections of regulatory submissions and clinical protocols (e.g. INDs, IBs, CTDs, BLAs).
• Represents Immunome's science to external stakeholders

Qualification

• A minimum of a PhD and 6+ years of industry experience, or MS/BS in a relevant scientific discipline and 10+ years of industry experience in the DMPK/ADME function.
• Experience with various drug modalities such as small molecules, large molecules, and ADCs, is required.
• Experience in the successful submission of at least three global filings (IND/NDA/BLA).

Knowledge and Skills

• Industry DMPK sciences with various modalities such as ADC, small molecule, or monoclonal antibodies.
• Hands on PK/TK analysis and PKPD modeling.
• Experience in authoring relevant sections of global regulatory submissions.
• Excellent skills in assessment of the appropriate DMPK experiments to support clinical development at all stages of product development.
• Understanding of non-regulated and regulated bioanalysis.
• Excellent problem solving skills and the ability and desire to oversee multiple projects simultaneously in a fast-paced environment.
• Outstanding interpersonal and communication skills (written and oral) with the ability to communicate complex information succinctly.

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.