Associate Director, Clinical Pharmacology
AbbVie
6 hours ago
Remote friendly (North Chicago, IL)
United States
Clinical Research and Development
Purpose
Conceives, executes, and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies to achieve commercial goals and regulatory requirements. Generates new PK/PD study proposals and leads efforts. Anticipates and critically evaluates Clinical Pharmacology/PK/PD/regulatory advances and responds with appropriate new strategies. Leads Clinical Pharmacology/PK/PD aspects of multiple projects and evaluates technical/scientific aspects with Clinical Pharmacology and Pharmacometrics management.
Responsibilities
- Accountable for Phase 1–4 studies design and clinical pharmacology strategy; acts as representative for projects.
- Executes strategy and leads teams/data analyses and interpretation; provides context including MoA/disease specifics, internal/external data, analysis plans, and interpretation of model results.
- Authors regulatory documents: protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, investigator brochure sections, white papers, and similar documents.
- Leads clinical pharmacology and biopharmaceutics meetings; serves as Clinical Pharmacology representative on Clinical Strategy Team/Asset Development Team; presents to departmental and cross-functional teams (study teams, leadership team, Journal club).
- Drives small teams to provide a unified Clinical Pharmacology position to clinical, CMC, and regulatory teams.
- Authors scientific publications; presents at national/international conferences; interacts with KOLs/external stakeholders.
- Conducts due diligence assessments; summarizes results; represents Clinical Pharmacology on business development teams.
- Represents Clinical Pharmacology at regulatory meetings.
Qualifications
- PhD (typically 4+ years) or PharmD (typically 6+ years) in a relevant field; Master’s (typically 12+ years) or Bachelor’s (typically 14+ years). Relevant field includes PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, drug metabolism/transporters.
- Excellent interpersonal skills.
- Ability to interact with functional representatives and KOLs (externally/internal) and lead teams.
- Strategic thinking and enterprise view.
- Proven scientific track record and technical skills.
- Leadership competencies: delivers business results; persistence/resilience; acts respectfully yet courageously; connects unrelated concepts/original ideas; influences cross-functional alignment; accountable when delegating/accepts accountability.
Benefits
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible to participate in long-term incentive programs.
Application instructions
- For applicants in locations with pay disclosure requirements and reasonable accommodation information, follow the posting links (no additional instructions provided).
Conceives, executes, and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies to achieve commercial goals and regulatory requirements. Generates new PK/PD study proposals and leads efforts. Anticipates and critically evaluates Clinical Pharmacology/PK/PD/regulatory advances and responds with appropriate new strategies. Leads Clinical Pharmacology/PK/PD aspects of multiple projects and evaluates technical/scientific aspects with Clinical Pharmacology and Pharmacometrics management.
Responsibilities
- Accountable for Phase 1–4 studies design and clinical pharmacology strategy; acts as representative for projects.
- Executes strategy and leads teams/data analyses and interpretation; provides context including MoA/disease specifics, internal/external data, analysis plans, and interpretation of model results.
- Authors regulatory documents: protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, investigator brochure sections, white papers, and similar documents.
- Leads clinical pharmacology and biopharmaceutics meetings; serves as Clinical Pharmacology representative on Clinical Strategy Team/Asset Development Team; presents to departmental and cross-functional teams (study teams, leadership team, Journal club).
- Drives small teams to provide a unified Clinical Pharmacology position to clinical, CMC, and regulatory teams.
- Authors scientific publications; presents at national/international conferences; interacts with KOLs/external stakeholders.
- Conducts due diligence assessments; summarizes results; represents Clinical Pharmacology on business development teams.
- Represents Clinical Pharmacology at regulatory meetings.
Qualifications
- PhD (typically 4+ years) or PharmD (typically 6+ years) in a relevant field; Master’s (typically 12+ years) or Bachelor’s (typically 14+ years). Relevant field includes PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, drug metabolism/transporters.
- Excellent interpersonal skills.
- Ability to interact with functional representatives and KOLs (externally/internal) and lead teams.
- Strategic thinking and enterprise view.
- Proven scientific track record and technical skills.
- Leadership competencies: delivers business results; persistence/resilience; acts respectfully yet courageously; connects unrelated concepts/original ideas; influences cross-functional alignment; accountable when delegating/accepts accountability.
Benefits
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible to participate in long-term incentive programs.
Application instructions
- For applicants in locations with pay disclosure requirements and reasonable accommodation information, follow the posting links (no additional instructions provided).