Associate Director/Director, Clinical Pharmacology and Pharmacometrics

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 Associate Director/Director, Clinical Pharmacology and Pharmacometrics will bring extensive experience in oncology quantitative pharmacology, clinical pharmacology strategy, and oncology drug development. This role reports to the Head of Clinical Pharmacology.

Responsibilities

• Excellent written/oral communication, interpersonal and problem-solving skills.
• Formulate and deliver CP&MS strategy for late-stage and early preclinical/clinical development assets.
• Apply pharmacokinetic/pharmacodynamics (PK/PD), physiologic based PK (PBPK) and pharmacometric modeling & simulation (M&S) approaches to characterize drug absorption and disposition and assess the dynamics of drug effect to inform dose selection and go/no-go decisions.
• Work with preclinical and clinical CROs and company scientists to conduct and monitor clinical pharmacology studies, maintain study records and ensure study completion along program timelines.
• Contribute and drive program strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.

Qualifications

• Ph.D., PharmD, M.D., or equivalent in a relevant scientific discipline (clinical pharmacology, pharmacometrics or closely related scientific discipline)
• 4+ years' experience in pharmaceutical/biotechnology industry in regulated bioanalytical environment, preferably with multiple modalities, including small molecule, large molecule and ADC experience.
• Extensive experience in noncompartmental and PBPK analyses and pharmacometric modeling and simulation oversight including use of WINNONLIN and NONMEM or similar statistical modeling software
• Knowledge of R, R-shiny, SAS, MATLAB, NONMEM, PBPK (gastroplus or Simcyp) or similar modeling software and substantial experience integrating quantitative clinical pharmacology with oncology drug development strategy
• Familiarity with current global clinical pharmacology and pharmacometrics regulatory guidance.
• Experience in successful submission of at least one global filing for approval (NDA/BLA is helpful. 
• Extensive experience managing relationships with clinical pharmacology vendors.
• Experience of development of anti-cancer agents, preferably ADCs and/or RLTs.

Knowledge and Skills

• Excellent written/oral communication, interpersonal and problem-solving skills.
• Experience in oncology drug development with small a large molecule clinical pharmacology strategy. Experience in translational aspects of drug discovery and development is strongly preferred.
• Ability to deliver integrated clinical pharmacology roadmap to registration and new product label.
• Can manage multiple project related workstreams simultaneously under tight timelines collaboratively.
• Experience managing clinical pharmacology related data transfers, analysis, reporting and related timelines.
• Experience interacting with global health authorities on optimal dosage design and clinical pharmacology strategy. Effective forms of written and spoken communication is essential (eg clinical pharmacology protocols, pharmacokinetic/pharmacometric reports and regulatory submissions and performing quality control).
• Knowledge of regulatory requirements governing drug development.
• Resourcefulness, pragmatism, creativity and an independent work ethic.

E/E/O

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