← All roles

Director of Clinical Pharmacology, Cambridge, MA

Isomorphic Labs· Clinical
Apply on company site
Hybrid (Cambridge, MA)full-timePosted 2mo ago

About the role

Director of Clinical Pharmacology to lead clinical pharmacology strategies for oncology and non-oncology small molecule programs at Isomorphic Labs, reporting to the Head of Early Development. Responsible for launching and managing clinical pharmacology plans, collaborating with CROs, and leveraging predictive AI to optimize dose and safety in global trials.

Responsibilities

  • Strategic Leadership: Design, independently launch, and execute comprehensive clinical pharmacology, bioanalysis, and modeling / simulation strategies for small molecule oncology and non-oncology programs from Phase 1 through late-stage development.
  • CRO Management: Oversee and partner with global clinical CROs to ensure high-quality, timely, and cost-effective execution of clinical pharmacology studies and bioanalysis/PK data analyses.
  • Study Design & Execution: Lead clinical pharmacology components of Phase 1 and 2 protocols, including dose-escalation strategies, dose rationale, PK sampling schemes, Food-Effect, and DDI assessments.
  • Data Analysis: Direct analysis, interpretation, and reporting of bioanalytical PK data; apply modeling (PopPK, exposure-response) to inform dose optimization and RP2D for pivotal studies.
  • Regulatory Interactions: Author/review human clinical pharmacology sections for INDs/CTAs, IBs, CSRs, NDA/MAA filings; represent company in regulatory meetings.
  • Innovative Technology: Leverage predictive AI models to enable data automation and deliver quality clinical packages with accelerated timelines (predictive human PK and DDI).
  • Translational Pharmacology: Build human PK/translational capabilities; apply PK modeling (mechanism-based, allometric, PBPK) to predict human clearance and efficacious doses; support FIH transitions.
  • Pipeline Strategy: Provide strategic input to identify developable candidates and advance to First-in-Human trials.
  • Use of AI in Translational Work: Apply predictive AI models to improve data packages and timelines.

Qualifications

  • Ph.D. or Pharm.D. in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences, or closely related discipline
  • 8+ years of biopharmaceutical industry experience with strategic leadership
  • Deep understanding of oncology and non-oncology drug development, including Phase 1 dose-escalation and registrational trial designs for small molecule therapies
  • Translational & Technical Skills: translating in-vitro/in-vivo data to human PK/dose predictions; experience with NONMEM, GastroPlus, Simcyp; leveraging predictive AI for PK/DDI
  • Vendor Oversight: experience selecting and managing global CROs and external vendors
  • Regulatory Experience: authoring clinical pharmacology sections for IND/NDA and interacting with FDA/EMA

Skills

Required:Clinical pharmacology strategyCRO managementStudy design & execution (Phase 1/2)PK/PD modeling (PopPK, exposure–response)Regulatory submissionsPredictive AI in pharmacology
Nice to have:NONMEM/GastroPlus/Simcyp

Benefits

  • Competitive compensation package (base; equity)
  • Comprehensive health benefits
  • Hybrid working with in-person collaboration 3 days/week
  • Global career development in a rapidly growing AI-driven biopharma
  • Accommodation for disability or needs per policy
Last updated Aug 19, 2026. Interested? Apply on the company site.

About Isomorphic Labs

Reimagining Drug Discovery Process with AI

Isomorphic Labs is building a future where frontier AI can help to unlock deeper scientific insights, faster breakthroughs, and life-changing medicines.

AIBiotechnologyDrug DiscoveryPharmaceuticalsliquid-ai-recruiting-target
Company profileWebsite

More open roles at Isomorphic Labs