Remote Senior ADME & Quantitative Pharmacology Director

dimensioncap.com; 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 lead DMPK, clinical pharmacology, and modeling & simulation across our expanding portfolio.

You will be a key member of the AQP team, guiding regulatory submissions and supporting IND, NDA, or BLA filings, while partnering with discovery and translational sciences to align development plans. This role demands strategic leadership, deep expertise in PK/PD, regulatory interactions with FDA/EMA, and the ability to manage

Qualifications

• PhD, PharmD, or MD in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences, or related field with 15+ years in biotech/pharma.
• Experience leading PK/PD modeling, dose finding, and exposure–response strategies.
• Strong knowledge of ICH, FDA, EMA guidelines for small molecule development.

Responsibilities

• Lead DMPK and PK/PD strategy across discovery and development programs, from nomination to regulatory submission.
• Drive clinical pharmacology strategy including dose finding and exposure–response analyses.
• Oversee PK/PD study design, analysis, and interpretation with cross-functional teams.
• Provide regulatory support for DMPK/Clinical Pharmacology in IND, NDA, and BLA filings.
• Act as SME for clinical pharmacology and DMPK in interactions with FDA, EMA, and other authorities.
• Partner with translational, discovery, and clinical teams to integrate nonclinical ADME data into development plans.
• Collaborate with Discovery and DMPK groups to provide PK/ADME support for discovery projects.
• Ensure alignment of DMPK/PKPD with development, manufacturing, and regulatory plans.
• Provide strategic leadership to AQP on scientific matters, including resource planning.

Skills

PK/PD expertise

Clinical pharmacology

Regulatory engagement

Leadership experience

Drug development

Education

PhD, PharmD, or MD

Job description

Enveda is seeking a Sr. ADME and Quantitative Pharmacology Director to lead DMPK, clinical pharmacology, and modeling & simulation across our expanding portfolio.

You will be a key member of the AQP team, guiding regulatory submissions and supporting IND, NDA, or BLA filings, while partnering with discovery and translational sciences to align development plans. This role demands strategic leadership, deep expertise in PK/PD, regulatory interactions with FDA/EMA, and the ability to manage