Senior ADME & Quantitative Pharmacology Director - Remote

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

Benefits offered by this job

Medical insurance

401k Match

Flexible PTO

Adoption Assistance

Job summary

Enveda is seeking a Sr. ADME and Quantitative Pharmacology Director to lead DMPK and PK/PD strategy across discovery and development. You will guide modeling, dose finding, and exposure–response analyses, interfacing with regulatory teams and global health authorities.

You will oversee clinical pharmacology programs, drive regulatory submissions, and collaborate with translational, discovery, and clinical teams to advance multiple therapeutic programs on a fast-moving portfolio.

Qualifications

• PhD/PharmD/MD with 15+ years in biotech/pharma.
• Expertise in PK/PD, modeling & simulation, dose finding, and exposure–response strategies.
• Strong knowledge of ICH/FDA/EMA guidelines for small molecule development.
• Regulatory representation experience for IND/NDA/BLA filings.
• Familiarity with CROs, collaborations, and cross-functional programs.
• Leadership in teams with influence from scientists to executives.
• Ability to manage multiple therapeutic programs in parallel.
• Bonus: familiarity with non-oral small molecule delivery/formulation.

Responsibilities

• Lead DMPK and PK/PD strategy across discovery and development programs.
• Drive clinical pharmacology strategy including dose finding and exposure–response analyses.
• Oversee study design, analysis, and interpretation with cross-functional teams.
• Provide regulatory support for submissions across DMPK/Clinical Pharmacology.
• Engage with FDA/EMA and global authorities as the subject-matter expert.
• Collaborate with translational, discovery, and clinical teams to integrate data.
• Align DMPK/PK/PD activities with development, manufacturing, and regulatory plans.
• Provide leadership to the AQP function on scientific matters.
• Plan and conduct phase-appropriate Clinical Pharmacology studies.

Skills

PK/PD

Modeling & Simulation

Dose Finding

Exposure–Response

Regulatory Strategy

CRO Management

Leadership

Multi-Program Management

Non-oral Delivery

Education

PhD/PharmD/MD in Pharmacokinetics/Clinical Pharmacology/Pharmaceutical Sciences

Job description

Enveda is seeking a Sr. ADME and Quantitative Pharmacology Director to lead DMPK and PK/PD strategy across discovery and development. You will guide modeling, dose finding, and exposure–response analyses, interfacing with regulatory teams and global health authorities.

You will oversee clinical pharmacology programs, drive regulatory submissions, and collaborate with translational, discovery, and clinical teams to advance multiple therapeutic programs on a fast-moving portfolio.