Senior Manager, Clinical Pharmacology & DMPK

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. The company’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and commitment to people. Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.

Summit is conducting multiple global Phase 3 clinical studies in oncology, including:

• Non-small Cell Lung Cancer (NSCLC):
  • HARMONi: Evaluates ivonescimab combined with chemotherapy vs. placebo plus chemotherapy in EGFR-mutated, locally advanced or metastatic non-squamous NSCLC (patients previously treated with a 3rd generation EGFR TKI).
  • HARMONi-3: Evaluates ivonescimab combined with chemotherapy vs. pembrolizumab combined with chemotherapy in first-line metastatic NSCLC.
  • HARMONi-7: Evaluates ivonescimab monotherapy vs. pembrolizumab monotherapy in first-line metastatic NSCLC.
• Colorectal Cancer (CRC):
  • HARMONi-GI3: Evaluates ivonescimab in combination with chemotherapy vs. bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy currently approved only by China’s National Medical Products Administration (NMPA).

About the role

The Senior Manager, Clinical Pharmacology & DMPK will manage clinical pharmacology, pharmacokinetic (PK), drug metabolism (DM), and bioanalytical (BA) support and operations for Summit’s assets. This role oversees PK and ADA sample management, vendor management, and data analysis to support projects.

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 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 non-compartmental analysis (NCA) data analysis, interpretation, and reporting.
• Perform all other duties as assigned.

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 across various clinical study phases.
• Understanding of clinical pharmacology concepts, conducting clinical pharmacology studies, and knowledge of regulatory requirements (GCP, ICH guidelines) related to clinical trials 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.

Pay

$148,000 – $174,000 USD. Actual compensation is based on factors unique to each candidate, including skill set, depth of experience, certifications, and work location. The total compensation package may also include bonus, stock, benefits, and other variable compensation.