Director, Clinical Pharmacology

Job Description
The Director, Clinical Pharmacology in Local Delivery Translational Sciences (LDTS) is accountable for translational pharmacokinetic (PK) and clinical pharmacology strategies for assets primarily in the eye care, neurotoxin, and aesthetic portfolio at AbbVie. The incumbent will provide technical and strategic leadership on Therapeutic Area (TA) specific issues related to non-clinical, clinical and quantitative pharmacology from the discovery stage up to the post-marketing support (PMS) stage, ensuring implementation of a model informed drug development (MIDD) paradigm to R&
D strategy at all stages. This role has multiple strategically important aspects that require the incumbent to provide strong cross-functional leadership across diverse stakeholders comprising Senior Leadership in Discovery, Development Sciences, Development, and Allergan Aesthetics.
Purpose:
Communicates/presents key Pharmacokinetic/Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers.
Leads strategic planning for drug development activities and projects to achieve departmental strategies, goals, and objectives.
Utilizes scientific expertise to provide appropriate interpretation of data and relates implications of results to management.
Serves as liaison to other departments/divisions for any study/project needs.
Influences and strategically manages linkages across businesses and understands the impact of business decisions and solutions.
Serves as a matrix leader within LDTS on department initiatives and accountable for effective performance of the workstream teams.
Responsibilities:
Provides TA specific non-clinical, clinical and quantitative pharmacology leadership and oversight in designing and executing, within the regulatory framework, non-clinical, PK and toxicokinetic (TK) studies during the discovery phase, and FIH, POC, Phase 1 to 4 studies during the clinical development phase.At the non-clinical stage, responsible for ensuring leadership on key milestones up to IND filing by collaborating with discovery, toxicology, clinical development, and clinical safety to enable selection of dose/regimen and patient population for FIH studies.
At the clinical stage, responsible for authoring and strategizing clinical pharmacology development plans and MIDD data analysis plans, identifying Phase 2/3 dose regimens, and providing strategic direction on writing reports and integrated summaries submitted to the regulatory authorities and interacting with the regulatory authorities.
Independently leads PK/PD/Clin Pharm activities and multiple major projects. Assists R&
D senior management in the selection of action plans that best meets drug discovery and development business objectives at the R&
D governance milestones.
Identifies issues impacting multiple complex projects and leads issue resolution. Conducts risk assessments and develops contingency plans. Assures project remains in alignment with strategic objectives.
Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/performance).
Provides expert scientific and strategic consultation to R&
D, Regulatory, and all levels of management on critical decisions and development plans. Connects scientific, regulatory, and business implications from multiple teams. Influences and strategically manages linkages across businesses and understands the impact of business decisions and solutions.
Responsible for critically evaluating technical, scientific aspects of eye care, neurotoxin, and aesthetic projects along with LDTS management. Reviews study protocols and scientific reports for regulatory filings and anticipates regulatory questions. Leads regulatory documents writing, submission and response to Regulatory agency comments.
Independently conducts due diligence assessments, summarizes results and represents LDTS on business development teams.
Identifies and develops process improvement initiatives and reviews recommendations with management for approval and sponsorship.
Manages personnel including development, mentoring, and effective delegation.
Leads teams within department, across LDTS 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.