[Hiring] Sr. ADME and Quantitative Pharmacology Director @Enveda

Role Description

Let’s build the future of medicine - together. Join Enveda as a Sr. ADME and Quantitative Pharmacology Director and help us transform natural compounds into life-changing medicines. We’re a team driven by curiosity and innovation - are you ready to make a difference?

As the Sr. ADME and Quantitative Pharmacology Director, you’ll provide strategic leadership across DMPK, clinical pharmacology, and modeling & simulation for our expanding portfolio. You will be a key member of the AQP team, reporting to the VP, AQP, and will oversee DMPK and PK/PD activities from candidate nomination through clinical development - making significant contributions to integrated drug development strategy within a diverse R&D organization.

What You’ll Do

• 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, collaborating 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.
• Act 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 closely 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, combining full-time and consulting resources.
• Plan and conduct stage-appropriate Clinical Pharmacology studies (Phase I/II/III) to support regulatory submissions.

Qualifications

• PhD, PharmD, or MD in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline with 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, with expert knowledge of those relating to Clinical Pharmacology/PK/PD.
• Proven success representing Clinical Pharmacology and DMPK in regulatory interactions with FDA and ideally other regulators (e.g., FDA Pre-IND and EMA Scientific Advice meetings), and supporting IND, NDA, or BLA filings.
• Extensive familiarity with major CROs and the ability to manage collaborations with CROs, academia, and industry partners.
• Leadership experience managing teams and cross-functional collaborations, with excellent communication skills and the ability to influence at all levels from scientists to executive leadership.
• Ability to manage multiple therapeutic programs in parallel and prioritize according to the needs of the company while delivering on 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