Sr. ADME and Quantitative Pharmacology Director

Enveda; United States; Remote; USD 340,000 - 390,000; Full time

Benefits offered by this job

90% Medical, Dental, Vision

401k Match

Flexible PTO

Adoption Assistance

Job summary

Enveda is seeking a Sr. ADME and Quantitative Pharmacology Director to provide strategic leadership across DMPK, Clinical Pharmacology, and modeling & simulation for our expanding portfolio.

You will oversee DMPK and PK/PD activities from candidate nomination through clinical development, shaping integrated drug development strategy within a diverse R&D organization. You’ll lead PK/PD strategy across programs, drive dose finding and exposure–response analyses, and collaborate with regulatory

Qualifications

• PhD/PharmD/MD with 15+ years in biotech or pharma.
• Proven PK/PD and modeling & simulation across nonclinical and clinical development.
• Strong knowledge of ICH, FDA, EMA regulations for small molecules.
• Experience representing Clinical Pharmacology/DMPK in regulatory interactions and IND/NDA/BLA filings.
• Leadership and cross-functional collaboration across discovery, translational and clinical teams.
• Ability to manage multiple programs and prioritize milestones.

Responsibilities

• Lead DMPK and PK/PD strategy across discovery and development programs through regulatory submission.
• Drive clinical pharmacology strategy including dose finding and exposure–response modeling.
• Oversee PK/PD study design, analysis, and interpretation with cross-functional teams.
• Provide regulatory support for DMPK, Clinical Pharmacology in submissions (IND, NDA, BLA).
• Act as subject-matter expert for clinical pharmacology and DMPK in interactions with health authorities.
• Partner with translational, discovery, and clinical teams to integrate nonclinical ADME data.
• Collaborate with Discovery and DMPK to support compound progression and optimization.
• Align DMPK/PKPD with development, manufacturing, and regulatory plans.
• Provide strategic leadership to AQP, combining internal and consulting resources.
• Plan and conduct stage-appropriate Clinical Pharmacology studies (Phase I–III) for submissions.

Skills

PK/PD expertise

Modeling & Simulation

Regulatory strategy

Leadership

Cross-functional collaboration

Regulatory filings experience

Education

PhD, PharmD, or MD in Pharmacokinetics/Clinical Pharmacology

Job 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?

Remote | Full‑Time | $340,000-$390,000

What Makes Us Enveda

Life is smart, and we can learn from it. We’re reinventing drug discovery by harnessing nature’s intelligence. Our platform identifies new medicines four times faster than the industry standard because patients can’t wait. What sets Enveda apart isn’t just what we do - it’s how we do it. Our culture is built on creativity, collaboration, and deep respect for each other. We believe “People Create All Value”, and our success is driven by the extraordinary team turning our mission into reality every day.

Our Momentum

• Unicorn status: Achieved following a $150 million Series D funding round in 2025
• Discovery and innovation: Advanced our first drug candidate to Phase 1 trials in 2024
• Award‑winning culture:
  • Newsweek: Top 100 Global #MostLovedWorkplaces (2025)
  • Forbes: America’s Best Startup Employers (2024 & 2025)
  • Newsweek: America’s Greatest Startup Workplaces (2025)
  • Fast Company: Most Innovative Companies in 2026

These milestones reflect the impact of our team and we’re just getting started, but they’re only possible because of the diverse talent, perspectives, and relentless drive of our team, and people like you.

Your Role in Our Mission

At Enveda, every role drives impact. 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

We’re Looking For

• 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

If you’re passionate about innovation and impact, we encourage you to apply even if you don’t meet every requirement.

Our Values: Curiosity | Agency | Journey | Charity | Unity

Benefits: 90% Medical, Dental, Vision | 401k Match | Flexible PTO | Adoption Assistance

Enveda is protecting Job Seekers

We care deeply about creating a safe, respectful experience for every applicant, so we wanted to share a few guidelines to help you spot anything that doesn’t feel right.

• You’ll always meet real Enveda team members through video or in‑person conversations before receiving an offer.
• All communication from us will come from an @enveda.com or @envedabio.com email address.
• We’ll never ask you to purchase equipment, send money, or share sensitive banking details as part of any step in our recruiting process.

If something feels off or you’re unsure whether a message is truly from Enveda, please reach out at anytime at [e-mail].

At Enveda, we’re building a place where everyone can do the best work of their life. We are an equal opportunity employer and value diversity in all its forms.