Sr. Director, Clinical Pharmacology & DMPK jobs in United States
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Summit Therapeutics, Inc. · 1 day ago

Sr. Director, Clinical Pharmacology & DMPK

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing serious unmet medical needs. The Sr. Director of Clinical Pharmacology & DMPK will manage clinical pharmacology and pharmacokinetic support for Summit’s assets, overseeing data analysis and regulatory submissions.

BiotechnologyHealth CareMedical DeviceTherapeutics
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H1B Sponsor Likelynote
Hiring Manager
Stacy B. Saltzer
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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

Qualification

Clinical PharmacologyPharmacokineticsDrug MetabolismBioanalytical SupportPK SoftwarePopulation PK AnalysisPKPD ModelingProject ManagementCommunication SkillsProblem-Solving Skills

Required

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

Benefits

Bonus
Stock
Benefits
Variable compensation

Company

Summit Therapeutics, Inc.

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Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.

H1B Sponsorship

Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (1)

Funding

Current Stage
Public Company
Total Funding
$1.79B
Key Investors
CARB-XEurofarmaBiomedical Advanced Research and Development Authority (BARDA)
2025-10-21Post Ipo Equity· $500M
2024-09-11Post Ipo Equity· $235M
2024-06-03Post Ipo Equity· $200M

Leadership Team

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Manmeet Soni
Chief Operating Officer and Board Member
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Company data provided by crunchbase