Senior Manager, Clinical Pharmacology & DMPK

Summit Therapeutics•Palo Alto, CA

9d•$148,000 - $174,000

About The Position

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. Summit’s 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. Summit’s team is inspired to touch and help change lives through Summit’s 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 China’s 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: The Senior Manager, Clinical Pharmacology & DMPK will manage clinical pharmacology, pharmacokinetic (PK), drug metabolism (DM) and bioanalytical (BA) supports and operation for Summit’s assets. This role is responsible for PK and ADA samples management, vendor management, and perform data analysis to support projects.

Requirements

Ph.D., Pharm.D., or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines with 1+ years of clinical pharmacology industry experience or M.S. with 5+ years of relevant experience
Experience in clinical trial design and execution, preferably in various phase clinical studies
Understanding of clinical pharmacology concepts and conducting clinical pharmacology studies and knowledge of regulatory requirements related to clinical trials (GCP, ICH guidelines), and drug development
Hands-on experience with standard PK Software (e.g., Phoenix WinNonlin).
Strong project management skills and ability to prioritize and manage multiple projects simultaneously
Excellent communication, organizational 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
Design and outsource in vitro and in vivo ADME studies to characterize the compounds
Manage external vendors for bioanalysis including validation and sample analysis
Oversee the collection, processing, storage, tracking, distribution and reconciliation of PK/ADA samples
Ensure data integrity and compliance with Good Clinical Practice (GCP) regulations throughout the drug development process
Collaborate with cross functional teams and central laboratories to manage sample logistics and chain-of-custody procedures
Perform NCA data analysis/interpretation, and reporting
All other duties as assigned