Sr. Director, Clinical Pharmacology & DMPK
About The Position
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summits core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: Manage clinical pharmacology, pharmacokinetic (PK), drug metabolism (DM) and bioanalytical (BA) supports for Summits assets. Responsible for PK and PKPD data analysis to support projects.
Requirements
- Ph.D., Pharm.D., or equivalent training in Pharmacokinetics, Pharmaceutical sciences, Biostatistics, or related disciplines with a minimum of 7+ years of clinical pharmacology industry experience or M.S. with 10+ years of relevant experience
- Hands-on experience with standard PK Software (e.g., Phoenix WinNonlin)
- Demonstrated computational skills related to pharmaceutical or biomedical research with hands-on programming skills in SAS, R, MATLAB; experiences with population PK analysis and PKPD modeling tools (e.g., NONMEM, and other modeling platforms) are required.
- Detail-oriented, highly organized, and able to manage multiple tasks
- Strong project management skills, detail-oriented, highly organized, ability to prioritize and manage multiple projects simultaneously
- Ability to function in a fast-paced environment with good communication and problem-solving skills
Responsibilities
- Serve as Clinical Pharmacology and DMPK subject matter expert on cross-functional teams in both early and late-stage projects
- Define ADME strategy to achieve target product profile
- Design and outsource in vitro and in vivo ADME studies to characterize the compounds
- Oversee external bioanalysis including validation and sample analysis
- Design and perform complex PK analysis, model development, population PK and PK/PD analyses
- Interprets and presents Clinical Pharmacology and DMPK scientific data/results to the team
- Assists in clinical study protocol design, sample collection plan, data analysis/interpretation, and reporting
- Write, review and edit relevant sections of regulatory submissions IND, DSUR, NDA, etc., and respond to queries from regulatory agencies
- All other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
