Senior ADME and Quantitative Pharmacology Director

🕒 June 15

🇺🇸 United States – Remote

💵 $340k - $390k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 41%

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Enveda

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

🔥 Funding within the last year

💰 $150M Series D - Enveda Biosciences on 2025-09

Healthcare • Consulting • Manufacturing

Enveda is a biotechnology company that leverages a proprietary platform to decode and translate nature’s chemical diversity for accelerated small-molecule drug discovery. By rapidly purifying, identifying, and characterizing molecules from complex natural sources, Enveda aims to put vast, evolutionarily derived chemical space into the hands of drug hunters to discover medicines faster and expand the pipeline of therapeutics.

📋 Description

• Provide strategic leadership across DMPK, clinical pharmacology, and modeling & simulation for the expanding portfolio • 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 • Oversee PK/PD study design, analysis, and interpretation • Collaborate with clinical operations, biostatistics, and regulatory colleagues • Provide scientific and regulatory support for DMPK, Clinical Pharmacology, and Biopharmaceutics sections of IND, NDA, and BLA filings • Act as subject-matter expert 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 • Provide PK/ADME support for discovery projects and compound selection and optimization • Align DMPK and PK/PD activities with clinical development, manufacturing, and regulatory plans • Provide strategic and technical leadership to the AQP function • Plan and conduct Clinical Pharmacology studies across Phases I, II, and III • Report to the VP, AQP

🎯 Requirements

• PhD, PharmD, or MD in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline • 15+ years of relevant experience in biotech or pharma • Demonstrated expertise in PK/PD, modeling & simulation, dose finding, and exposure-response strategies across nonclinical and clinical development • Strong knowledge of Health Authority regulations and guidelines (ICH, FDA, EMA) for the development of small molecule therapies • Expert knowledge of regulations relating to Clinical Pharmacology/PK/PD • Proven success representing Clinical Pharmacology and DMPK in regulatory interactions with FDA and ideally other regulators • Experience supporting IND, NDA, or BLA filings • Extensive familiarity with major CROs • Ability to manage collaborations with CROs, academia, and industry partners • Leadership experience managing teams and cross-functional collaborations • Excellent communication skills and ability to influence at all levels from scientists to executive leadership • Ability to manage multiple therapeutic programs in parallel and prioritize according to company needs while delivering key milestones • Familiarity with non-oral small molecule delivery (formulation) approaches is a bonus • Strong appreciation for research with a focus on product development

🏖️ Benefits

• 90% Medical, Dental, Vision • 401k Match • Flexible PTO • Adoption Assistance

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