Director of Clinical Pharmacology, Cambridge, MA

Isomorphic Labs
Cambridge
Workplace: OnsiteFull timeFunction: Executive & General ManagementExperience: 8+ yearsEducation: phdSkills: ["Independent execution","Cross-functional collaboration","Scientific communication","Strategic leadership","Ability to operate in a fast-paced environment"]

Lead clinical pharmacology strategy for oncology and non-oncology small-molecule programs, serving as the single point of accountability for global clinical pharmacology activities. Design and execute clinical pharmacology and bioanalysis plans (Phase 1 through late-stage), oversee CROs, and guide study protocol components. Translate PK and bioanalytical data into human dose models using methods like PopPK and PBPK, author regulatory submissions, and apply predictive AI to accelerate quality clinical packages.

Loading

Loading job details...

Preparing the role view and application actions.

FursaFursa
Isomorphic Labs
Isomorphic Labs
2 days ago

Director of Clinical Pharmacology, Cambridge, MA

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 2 hours agoStatus: Live

Job Summary

Lead clinical pharmacology strategy for oncology and non-oncology small-molecule programs, serving as the single point of accountability for global clinical pharmacology activities. Design and execute clinical pharmacology and bioanalysis plans (Phase 1 through late-stage), oversee CROs, and guide study protocol components. Translate PK and bioanalytical data into human dose models using methods like PopPK and PBPK, author regulatory submissions, and apply predictive AI to accelerate quality clinical packages.
Location: Cambridge
Workplace: Onsite
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Director level

Key Responsibilities

  • •Independently launch, execute, and manage clinical pharmacology strategies for small-molecule oncology and non-oncology programs across development (Phase 1 through late-stage).
  • •Oversee and partner with global clinical CROs and vendors to ensure high-quality, timely, and cost-effective execution of clinical pharmacology and bioanalysis studies.
  • •Lead clinical pharmacology components of Phase 1 and 2 protocols, including dose-escalation strategies, dose rationale, PK sampling schemes, food-effect, and DDI assessments.
  • •Direct analysis, interpretation, and reporting of bioanalytical PK data and apply modeling approaches (e.g., PopPK, exposure-response) to support dose optimization and RP2D selection.
  • •Author and review human clinical pharmacology and biopharmaceutics sections for regulatory documents and represent the company in regulatory authority meetings.

Key Requirements

  • •Ph.D. or Pharm.D. in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences, or a closely related discipline.
  • •8+ years of relevant biopharmaceutical industry experience with a track record of strategic leadership.
  • •Deep understanding of oncology and non-oncology drug development, including Phase 1 dose-escalation and registrational trial designs for small-molecule targeted therapies.
  • •Ability to translate in-vitro and in-vivo data into human PK and dose predictions, with hands-on experience overseeing vendors using modeling tools such as NONMEM, GastroPlus, or Simcyp.
  • •Proven experience authoring clinical pharmacology sections for regulatory submissions (IND, NDA) and interacting with health authorities (FDA, EMA).
Experience:8+ yearsBiopharmaceutical industryOncologyNon-oncologySmall molecules
Education:PhD / Doctorate in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences, or a closely related discipline
Skills:Independent executionCross-functional collaborationScientific communicationStrategic leadershipAbility to operate in a fast-paced environment
Tech Stack:Predictive AI modelsPK dataBioanalytical PK dataPopPKExposure-responseNONMEMGastroPlusSimcypPBPKMass balance (AME)DDI (drug-drug interaction)Food-EffectINDNDACTACSRsInvestigator Brochures (IBs)NDA/MAA filings

Company Brief

Isomorphic Labs
Uses machine learning and computational biology to accelerate drug discovery and design novel therapeutics by modeling protein structures, mechanisms, and interactions to identify promising targets and candidates.
Industry: Biotech
Company Size: Medium (51 to 250 employees)
Growth: Growth Stage Startup
Headquarters: London, United Kingdom
Founded: 2021
WebsiteLinkedIn