Senior Director, Clinical Pharmacology and Pharmacometrics
- Military veterans preferred
2024-05-15 AppCast (https://www.appcast.io)
Other
/yr
full-time
employee
Bothell Washington 98021 United States
Job Title: Senior Director, Clinical Pharmacology and Pharmacometrics
Company: Immunome, Inc.
Location: Bothell
Company Overview
Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, targeted effectors, radioligand therapies and antibody drug conjugates (ADCs). We believe that pursuing underexplored targets with appropriate drug modalities leads to transformative therapies. Our proprietary memory B cell hybridoma technology allows for the rapid screening and functional characterization of novel antibodies and targets.
Position Overview
The Senior 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 ED Quantitative Pharmacology and Disposition.
Responsibilities
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.
Requirements
Qualifications
Ph.D. in a relevant scientific discipline (clinical pharmacology, pharmacometrics or closely related scientific discipline)
10+ 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).
Extensive experience managing relationships with clinical pharmacology vendors.
Experience of development of anti-cancer agents, preferably ADCs and/or RLTs.
Knowledge and 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.
Ability to 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.
