Purpose: 

Conceives, executes and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD study proposals and leads those efforts. Anticipates and critically evaluates Clinical Pharmacology, PK/PD or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies. Consistently demonstrates excellent record of accomplishment of Clinical Pharmacology and business objectives. Leads Clinical Pharmacology/PK/PD aspects of multiple projects. Responsible for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics (CPPM) management.

Responsibilities: 

• Accountable for Phase 1-4 studies design, and clinical pharmacology strategy; acts as the representative for project(s).
• Executes strategy, lead teams and various data analyses and interpretation by providing necessary context (including explaining MoA and disease specifics, available relevant internal and external data, analysis plans, interpretation and discussion of model results in the context of research question).
• Author regulatory documents including protocols, study reports, population PK reports, exposure-response analyses reports, CTDs, label sections, relevant section of investigator brochures, white papers, and other similar documents.
• Leads clinical pharmacology and biopharmaceutics meetings, serve as CPPM representative at Clinical Strategy Team/Asset Development Team and present at various departmental and cross functional teams such as study teams, CPPM leadership team, Journal club.
• Drives small teams with members from CPPM functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams.
• Authors scientific publications and present at national and international conferences and interact with KOLs/external stakeholders.
• Conducts due diligence assessments, summarizes results and represents CPPM on business development teams.
• Represents CPPM at regulatory meetings.

• PhD with 4+ years of experience or Pharm D with 6+ years of experience in a relevant field*;(*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