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. 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)
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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.
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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.
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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)
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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 Associate Director, Clinical Pharmacology & DMPK will manage clinical pharmacology, pharmacokinetic (PK), drug metabolism (DM) and data analysis supports and operation for Summit’s assets. This role is responsible for pharmacometrics, model-informed drug development (MIDD), including PK, PK/PD, population PK, exposure-response, and Model-based meta-analysis (MBMA) to support Summit’s clinical development programs.
This role will combine hands-on quantitative analyses with strategic scientific contribution to support clinical development, dose optimization, benefit-risk assessment, and regulatory submissions.
The individual will collaborate closely with cross-functional project teams and provide oversight of external pharmacometrics vendors and consultants, as appropriate.
Role and Responsibilities:
- Serve as a pharmacometrics subject matter expert on cross-functional project teams and contribute to clinical pharmacology and model-informed drug development strategies.
- Independently design, conduct, interpret, and report NCA, PopPK, PK/PD, Model-based meta-analysis (MBMA), and exposure-response analysis, including hands-on data processing, modeling, simulation, visualization, and interpretation.
- Develop and apply quantitative models and simulations to support clinical trial design, address key drug development questions and support program decisions, assessment of clinically relevant covariates, and benefit-risk evaluation.
- Collaborate cross-functionally with Clinical Development, Biostatistics, Statistical Programming, Data Management, Translational Medicine, Regulatory Affairs, and other functions to support appropriate data collection, analysis, and interpretation.
- Develop pharmacometric analysis plans, and draft analysis reports or relevant sections in regulatory submission documents. Contribute quantitative analyses and scientific rationale to regulatory interactions and responses to health authority questions.
- Provide scientific and technical oversight of external pharmacometrics service providers and consultants, including review of analysis plans, datasets, models, outputs, and reports.
- All other duties as assigned.
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- Ph.D., Pharm.D., or equivalent advanced degree in pharmacometrics, pharmacokinetics, pharmaceutical sciences, pharmacology, biomedical engineering, applied mathematics/statistics, or a related discipline with 3+ years of relevant pharmaceutical/biotechnology industry experience; or M.S. with 5+ years of relevant experience.
- Demonstrated hands-on quantitative modeling experience and proficiency with pharmacometric software, including NONMEM/PsN, R, and Phoenix WinNonlin, or comparable tools.
- Experience applying modeling and simulation to support dose selection/optimization, clinical trial design, benefit-risk assessment, and development decision-making.
- Experience drafting pharmacometric and clinical pharmacology analysis reports and supporting regulatory submissions. Experience contributing to responses to regulatory agency questions is preferred.
- Working knowledge of drug development and applicable FDA, ICH, and other regulatory expectations for clinical pharmacology and pharmacometrics.
- Experience managing external pharmacometrics vendors, CROs, or consultants is preferred.
- Strong scientific, technical writing, communication, problem-solving, and project management skills, with the ability to work effectively on multidisciplinary teams.
This is the pay for this position
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at [email protected] to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.