Director DMPK
Vor 7 Stunden
Sachseln, Obwalden, Schweiz
Proclinical
Vollzeit
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Director DMPK
- Permanent, Full time
- Bay Area, CA (Hybrid: 2 days onsite / 3 days remote)Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.
Proclinical is seeking a highly motivated Director, DMPK to join an innovative, clinical-stage biotechnology environment focused on advancing novel small-molecule therapies for immune-mediated inflammatory diseases. This is a senior scientific leadership role offering the opportunity to shape DMPK strategy from discovery through clinical development in a fast-paced, collaborative setting.
The Role:As Director, DMPK, you will provide technical and scientific leadership across discovery and development programs, serving as the DMPK subject matter expert and program lead. You will define and execute ADME, PK, and PK-PD strategies, support key development decisions, and play a critical role in first-in-human dose predictions and regulatory submissions. You will work cross-functionally with medicinal chemistry, toxicology, pharmacology, CMC, and clinical teams, and manage external partners to ensure high-quality, timely DMPK execution.
Key Responsibilities
Lead and implement DMPK and PK-PD strategies aligned with discovery and development objectivesServe as DMPK program lead, responsible for study design, execution, analysis, interpretation, and reportingProvide expert interpretation of DMPK data and present findings to project teams, senior leadership, and external stakeholdersCollaborate closely across RD functions to enable data-driven decision-makingOversee bioanalytical and DMPK studies conducted internally and through CROsAuthor and review PK/DMPK sections of regulatory documents (IND, IB, CTA, NDA/BLA) and respond to regulatory inquiriesSupport clinical pharmacology activities, including first-in-human dose projectionsMaintain high standards of scientific rigor, quality, and documentationQualificationsPhD in pharmacokinetics, drug metabolism, or a related discipline6+ years of small-molecule DMPK experience in the pharmaceutical or biotechnology industryProven track record leading DMPK efforts across discovery and developmentExperience with clinical candidate selection and translational PK/PDHands-on experience analyzing PK and PK-PD data using relevant software toolsStrong understanding of regulatory guidelines supporting small-molecule drug developmentExperience preparing regulatory submissions and interacting with U.
S. and international regulatory agenciesAbility to oversee bioanalytical method development and validationLeadership SkillsInfluential scientific leader with direct accountability for DMPK strategyExcellent written and verbal communication skillsStrong analytical and problem-solving abilitiesDetail-oriented, adaptable, and comfortable working hands-on in a small, fast-moving organizationCompensation BenefitsSalary: US$190,000
- US$240,000 (commensurate with experience)Eligibility for performance-based bonuses and/or equity compensationComprehensive benefits package including health, dental, vision, 401(k), generous time-off programs, paid parental leave, and additional insurance offeringsThis role offers a unique opportunity to make a meaningful impact on the development of tansformative therapies while working alongside a passionate, high-caliber team.
- Permanent, Full time
- Bay Area, CA (Hybrid: 2 days onsite / 3 days remote)Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.
Proclinical is seeking a highly motivated Director, DMPK to join an innovative, clinical-stage biotechnology environment focused on advancing novel small-molecule therapies for immune-mediated inflammatory diseases. This is a senior scientific leadership role offering the opportunity to shape DMPK strategy from discovery through clinical development in a fast-paced, collaborative setting.
The Role:As Director, DMPK, you will provide technical and scientific leadership across discovery and development programs, serving as the DMPK subject matter expert and program lead. You will define and execute ADME, PK, and PK-PD strategies, support key development decisions, and play a critical role in first-in-human dose predictions and regulatory submissions. You will work cross-functionally with medicinal chemistry, toxicology, pharmacology, CMC, and clinical teams, and manage external partners to ensure high-quality, timely DMPK execution.
Key Responsibilities
Lead and implement DMPK and PK-PD strategies aligned with discovery and development objectivesServe as DMPK program lead, responsible for study design, execution, analysis, interpretation, and reportingProvide expert interpretation of DMPK data and present findings to project teams, senior leadership, and external stakeholdersCollaborate closely across RD functions to enable data-driven decision-makingOversee bioanalytical and DMPK studies conducted internally and through CROsAuthor and review PK/DMPK sections of regulatory documents (IND, IB, CTA, NDA/BLA) and respond to regulatory inquiriesSupport clinical pharmacology activities, including first-in-human dose projectionsMaintain high standards of scientific rigor, quality, and documentationQualificationsPhD in pharmacokinetics, drug metabolism, or a related discipline6+ years of small-molecule DMPK experience in the pharmaceutical or biotechnology industryProven track record leading DMPK efforts across discovery and developmentExperience with clinical candidate selection and translational PK/PDHands-on experience analyzing PK and PK-PD data using relevant software toolsStrong understanding of regulatory guidelines supporting small-molecule drug developmentExperience preparing regulatory submissions and interacting with U.
S. and international regulatory agenciesAbility to oversee bioanalytical method development and validationLeadership SkillsInfluential scientific leader with direct accountability for DMPK strategyExcellent written and verbal communication skillsStrong analytical and problem-solving abilitiesDetail-oriented, adaptable, and comfortable working hands-on in a small, fast-moving organizationCompensation BenefitsSalary: US$190,000
- US$240,000 (commensurate with experience)Eligibility for performance-based bonuses and/or equity compensationComprehensive benefits package including health, dental, vision, 401(k), generous time-off programs, paid parental leave, and additional insurance offeringsThis role offers a unique opportunity to make a meaningful impact on the development of tansformative therapies while working alongside a passionate, high-caliber team.