Senior Oncology Pharmacology Expert
2 days ago
Unlock Your Potential in Clinical Pharmacology
We are seeking an experienced Senior Oncology Pharmacology Expert to join our team at Immunome, Inc.
About the Role
The Senior Oncology Pharmacology Expert 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
- 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.
About the Company
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Location
Bothell, WA, USA
Job Type
Full-time
Salary Range
$175,189 - $237,442 USD per year
This figure includes a compensation package based on the job's requirements and national standards.
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