✦ Luna Orbit — Science & Research

Associate Director, Clinical Pharmacology

at AbbVie

📍 North Chicago, IL Unknown Posted April 15, 2026
Apply Now → ← Browse All Jobs

Position Details

Type Full-Time
Experience executive
Exp. Years 12+ years (Master's) or 14+ years (Bachelor's) or 4+ years (PhD) or 6+ years (Pharm D) as described
Education PhD or Pharm D or relevant advanced degree (Master's) or equivalent education
Category Science & Research

About this role

Lead Clinical Pharmacology and PK/PD strategy across multiple Phase 1-4 programs. Own study design, generate PK/PD study proposals, interpret model results, and author key regulatory documents while representing Clinical Pharmacology in cross-functional and regulatory forums.

Key Responsibilities

  • Conceive and execute multi-disciplinary Clinical Pharmacology development plans and strategies for commercial and regulatory goals
  • Accountable for Phase 1-4 studies design and Clinical Pharmacology strategy
  • Author regulatory documents including protocols, population PK reports, exposure-response analyses, CTDs, and label sections
  • Lead Clinical Pharmacology/biopharmaceutics meetings and represent Clinical Pharmacology at clinical strategy/asset development teams
  • Conduct due diligence assessments and represent Clinical Pharmacology on business development teams

Technical Overview

Scope includes PK/PD and Pharmacometrics leadership (including PBPK, population PK, and exposure-response analysis), along with model interpretation in the context of mechanistic understanding (MoA/disease specifics). Responsible for producing regulatory-facing deliverables such as protocols, study reports, population PK reports, CTDs, and label sections, and presenting technical outcomes to stakeholders and KOLs.

Ideal Candidate

The ideal candidate has a PhD or Pharm D and 12+ years of experience in Clinical Pharmacology and Pharmacometrics (PK, PBPK, PK-PD). They independently lead Phase 1-4 studies design and create PK/PD study proposals while authoring regulatory documents such as protocols, CTDs, and label sections. Strong strategic thinking, cross-functional leadership, and experience presenting to KOLs and regulatory meetings are essential.

Must-Have Skills

Phase 1-4 studies designclinical pharmacology strategyauthor regulatory documents including protocolspharmacometric managementPK/PD experience (PKPBPKPK-PDPharmacometrics or systems pharmacology)ability to respond with appropriate new strategies based on clinical pharmacology/PK/PD/regulatory advanceslead teams and data analyses and interpretation

Required Skills

Phase 1-4 studies designClinical pharmacology strategyPK/PD study proposalspopulation PK reportsexposure-response analyses reportsCTDslabel sectionsinvestigator brochuresdue diligence assessmentsKOLsclinical pharmacology meetingsbiopharmaceutics meetingsregulatory meetingspharmacometrics managementsystems pharmacologyDrug metabolism/TransportersMoA interpretationPBPKPK-PD

Hard Skills

Phase 1-4 studies designClinical pharmacology strategyPK/PD study proposalspopulation PK reportsexposure-response analyses reportsCTDslabel sectionsinvestigator brochuresregulatory documents authoringdue diligence assessmentspopulation pharmacokineticspharmacodynamicspharmacometics managementsystems pharmacologyDrug metabolism/TransportersMoA interpretationPBPKPK-PDexposure-response analysismodel results interpretationdata analysis and interpretationclinical pharmacology meetings leadershipbiopharmaceutics meetings leadershippresentation of scientific plans and dataauthorship of scientific publicationswhite papers

Soft Skills

interpersonal skillsability to interact with KOLsability to lead teamsstrategic thinkingenterprise viewcross-functional collaborationexcellent record of accomplishmentcommunication and management of multi-disciplinary plansstakeholder managementscientific leadership

Industry & Role

Industry Healthcare IT
Job Function Provide executive-level Clinical Pharmacology and Pharmacometrics leadership for study design, regulatory deliverables, and cross-functional scientific strategy.
Role Subtype Research Scientist

Keywords for Your Resume

Associate DirectorClinical PharmacologyPharmacologyPhase 1-4Phase 1-4 studies designPK/PDPBPKPK-PDpharmacometricssystems pharmacologyDrug metabolism/Transporterspopulation PK reportsexposure-response analyses reportsCTDsprotocolsprotocol authoringlabel sectionsinvestigator brochuresdue diligence assessmentsKOLsclinical pharmacology meetingsbiopharmaceutics meetingsregulatory meetingsstrategic thinkingenterprise viewclinical strategy teamasset development teamscientific publications

Deal Breakers

Must have PhD (4+ years) or Pharm D (6+ years) OR Master's (12+ years) OR Bachelor's (14+ years) in relevant PK/pharmacology fields, Must demonstrate experience in Phase 1-4 studies design and clinical pharmacology strategy

Apply for this Position →

Get matched to jobs like this

Luna finds roles that fit your skills and career goals — no endless scrolling required.

Create a Free Profile