- Leads, integrates and directs strategy for clinical development activities, such as dose selection, of a medium Therapeutic Area or large indication within a larger TA and communicates strategy to executive management, regulatory agencies, and external peers.
- Leads the strategic planning for drug development activities and projects to define the clinical pharmacology development strategies, goals, objectives, and submission documents.
- Develops dosing strategies and execution to ensure effective clinical trial end points relative to drug development opportunities.
- Oversees the evaluation of pharmacokinetics/ pharmacodynamics, culminating in translation into informative labeling guidance.
- Leads and executes the strategic integration of modeling and simulation, absorption, distribution, metabolism and pharmacology for drug safety.
- Influences and strategically manages linkages across businesses at a senior level and understands the impact of business decisions and solutions.
- This job represents the top of the Pharmacology for a medium TA or a leader of a large indication within a large TA.
- Provides strategic leadership and direction of Clinical Pharmacology/PK/PD strategy for medium TA or large indication and oversees execution of significant projects. Selects action plans that best meets drug development business objectives.
- May lead Clinical Pharmacology governance committees and provides expert Drug Development strategic input to R&D, RA, Medical Affairs, commercial and all levels of R&D
- Conducts scientific due diligence for medium TA or large indication within a large TA, acquisitions or co-development opportunities and may oversee due diligence reviews from more junior team members
- Provides critical interpretation of study-related projects for external publications, project reviews, reports and/or regulatory submissions. May be a critical reviewer/author in high-impact factor peer-reviewed journals, R&D reports, and/or regulatory documents/filings
- For Medium TA Lead, analyzes the impact of Clinical Pharmacology decisions on projects and programs across multiple complex projects. Influences and strategically manages linkages across businesses and understands the impact of business decisions and solutions.
- Integrates knowledge of all aspects of development from Discovery through Phase 4 (exposure, safety, efficacy, formulation, regulatory impact) and competitive information
- For Medium TA Lead, establish and maintain effective and timely multi-directional communication within the R&D, internal governance committees, and functional area management
- Drives strategic process improvement initiatives and reviews recommendations.
- For Medium TA Lead, establishes TA goals in alignment with R&D and Development strategic priorities.
- Develops capabilities of leaders on their team and holds them accountable for ensuring extended team is being developed.
- Holds leadership team accountable for effective performance of the team. Models behaviors high performing teams.
- Has responsibility in maintaining Clinical Pharmacology and R&D standards, GxP compliance, and operating practices for self and reporting staff including personnel development
- Leads teams within department, across Clinical Pharmacology and across functions. Responsible for leadership of cross-functional teams and accountable for effective performance of the team. Actively manages project team behaviors, mediates internal team disputes, and facilitates establishment of healthy and high performing teams.
- PhD with 12+ years of experience or Pharm D with 15+ 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
- Advanced knowledge and experience in multiple therapeutic and/or functional areas
- Experience across range of development phases
- Recognized as an expert with global knowledge of AbbVie and Pharma drug development processes
- Must have demonstrated strong leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometrics activities from planning, implementation through completion across multiple complex projects
- Proven track record of effective leadership capabilities and broad scientific and business-related orientations
- Demonstrated leadership of initiatives that advance the CPPM function
- Key Leadership Competencies:
- Knows the business and the cross-functional contributions needed to deliver results
- Manages conflict and difficult conversations in a constructive transparent way
- Develops direct reports and capable successors through coaching, stretch assignments and learning opportunities
- Respectfully provides transparent, accurate and timely feedback to help direct reports improve performance
- Creates an inclusive environment where all direct reports can succeed
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 15 % of the Time
Job Type: Experienced