Associate Director, Clinical Pharmacology
AbbVie · Irvine, CA · 1 wk ago
Analyst$142k–$269k/yrFull-time
About the role
The Associate Director, Clinical Pharmacology will conceive, execute, and manage multi-disciplinary Clinical Pharmacology development plans and strategies that align with commercial goals and regulatory requirements. They will lead the PK/PD aspects of multiple projects, anticipate and evaluate advancements, and develop new strategies accordingly.
Responsibilities
- Accountable for Phase 1-4 studies design and clinical pharmacology strategy; acts as the representative for project(s).
- Executes strategy, leads teams, and performs data analyses and interpretations, providing necessary context (explaining MoA and disease specifics, relevant data, analysis plans, and model results).
- Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, investigator brochures, white papers, and other similar documents.
- Leads clinical pharmacology and biopharmaceutics meetings, serves as CLINICAL PHARMACOLOGY representative at Clinical Strategy Team/Asset Development Team, and presents at various departmental and cross-functional teams.
- Drives small teams with members from CLINICAL PHARMACOLOGY functional groups to provide a unified clinical pharmacology position to clinical, CMC, and regulatory teams.
- Authors scientific publications and presents at national and international conferences, interacts with KOLs/external stakeholders.
- Conducts due diligence assessments, summarizes results, and represents CLINICAL PHARMACOLOGY on business development teams.
- Represents Clinical Pharmacology at regulatory meetings.
Requirements
- PhD with typically 4+ years of experience or Pharm D with typically 6+ years of experience in a relevant field, Master’s Degree or equivalent education and typically 12+ years of experience, Bachelor’s Degree or equivalent education and typically 14+ years of experience; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
- Excellent interpersonal skills
- Ability to interact with functional representatives and KOLs externally and internally and lead team(s)
- Strategic thinking and enterprise view
- Proven scientific track record and technical skills to perform the role
- Key Leadership Competencies:
- Delivers business results while also positioning AbbVie for long-term success
- Persistent and resilient finds the way to move good ideas forward
- Acts respectfully yet courageously
- Connects unrelated concepts, generates original or unique ideas
- Influences colleagues to achieve cross-functional alignment
- Gives full accountability when delegating and accepts full accountability when delegated to by others
Qualifications
- PhD with typically 4+ years of experience or Pharm D with typically 6+ years of experience in a relevant field, Master’s Degree or equivalent education and typically 12+ years of experience, Bachelor’s Degree or equivalent education and typically 14+ years of experience; (*relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters)
Skills
- Strategic thinking and enterprise view
- Proven scientific track record and technical skills to perform the role
- Leadership competencies as outlined above
Benefits
- Covered medical, dental, and vision insurance
- Comprehensive benefits package including paid time off (vacation, holidays, sick), and participation in long-term incentive programs
Pay
$141,500 - $268,500 USD
Schedule
Hybrid