Remote Senior ADME & PK/PD Strategy 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

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