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Enveda

Natural-product drug discovery platform leveraging ML

Senior ADME and Quantitative Pharmacology Director

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeRemote in USA$340k - $390kRemote

About the Job

Requirements

  • A PhD, PharmD, or MD in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline, with 15 or more years of relevant experience in biotech or pharma.
  • Demonstrated expertise in pharmacokinetics/pharmacodynamics (PK/PD), modeling and simulation, dose finding, and exposure-response strategies across nonclinical and clinical development.
  • Strong knowledge of health authority regulations and guidelines, including ICH, FDA, and EMA requirements for small-molecule development, with expert knowledge of requirements related to clinical pharmacology and PK/PD.
  • Proven success representing Clinical Pharmacology and DMPK in regulatory interactions with FDA and ideally other regulators, and supporting IND, NDA, or BLA filings.
  • Extensive familiarity with major contract research organizations (CROs) and the ability to manage collaborations with CROs, academia, and industry partners.
  • Leadership experience managing teams and cross-functional collaborations.
  • Ability to manage multiple therapeutic programs in parallel and prioritize according to company needs while delivering key milestones.

Responsibilities

  • Lead DMPK and PK/PD strategy across discovery and development programs, from candidate nomination through clinical development and regulatory submission.
  • Drive clinical pharmacology strategy, including dose finding, exposure-response modeling, PK/PD analysis, and risk-benefit assessment for early- and late-stage programs.
  • Oversee PK/PD study design, analysis, and interpretation in collaboration with clinical operations, biostatistics, and regulatory colleagues.
  • Provide scientific and regulatory support for DMPK, Clinical Pharmacology, and Biopharmaceutics sections of regulatory submissions, including IND, NDA, and BLA filings.
  • Serve as the subject-matter expert for clinical pharmacology and DMPK in interactions with FDA, EMA, and other global health authorities.
  • Partner with translational, discovery, and clinical teams to integrate nonclinical ADME data into clinical development plans and support compound progression from pipeline to early development.
  • Work with Discovery and DMPK groups to provide PK/ADME support for discovery projects, enabling informed compound selection and optimization.
  • Ensure alignment of DMPK and PK/PD activities with clinical development, drug manufacturing, and regulatory plans across the portfolio.
  • Provide strategic and technical leadership to the AQP function on scientific matters, coordinating full-time and consulting resources.
  • Plan and conduct stage-appropriate Clinical Pharmacology studies (Phase I/II/III) to support regulatory submissions.

Desired Qualifications

  • Familiarity with non-oral small-molecule delivery and formulation approaches is a bonus.

About the Company

Enveda

Natural-product drug discovery platform leveraging ML

Enveda Biosciences uses machine learning, metabolomics, and robotics to explore the largely untapped natural world for drug discovery. Its main asset is a proprietary high-throughput platform that runs many experiments to generate a comprehensive dataset of small molecules, including their chemical structures, biological activity, and how they distribute in organs. This data helps identify potential drug leads quickly and supports partnerships with healthcare and pharmaceutical companies through collaborations and licensing of discoveries. Unlike many rivals, Enveda focuses on expanding knowledge of natural product chemistry beyond the small portion already known, aiming to accelerate the pace of drug discovery by systematically exploring natural chemical space and building a pipeline for its partners.

Company size
201-500
Company stage
Series D
Total funding
$534.8M
Headquarters
Boulder, CO
Founded
2019

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