Director, Clinical Pharmacology
3 weeks ago
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
As a Director within the Clinical Pharmacology Neuroscience Group at AbbVie, you will lead clinical pharmacology programs in the Neuroscience/Psychiatry drug development area. You will have a seat at the table within asset teams to influence, decide, and recommend key clinical pharmacology strategies and information. You will be responsible and accountable for a variety of programs across the drug development spectrum, ranging from first in human through approval, including life cycle management and post approval commitments/requirements. You will be expected to communicate/present and lead key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. In your role, you will lead strategic planning for drug development activities and projects to achieve departmental strategies, goals, and objectives. Utilizing scientific expertise to provide appropriate interpretation of data to relate implications of results to asset teams and management. You will serve as liaison to other departments/divisions for any study/project needs, influence and strategically manage linkages across businesses and understand the impact of business decisions and solutions. You will be expected to lead teams within Clinical Pharmacology and be accountable for effective performance of the teams.
Responsibilities
* Independently leads Clinical Pharmacology/PK/PD activities and multiple major projects. Assists asset teams and R&D senior management in the selection of action plans that best meets drug development business objectives.
* Identifies issues impacting multiple complex projects and leads issue resolution. Conducts risk assessments and leads the function in development of contingency plans. Assures project remains in alignment with strategic objectives.
* Provides overall clinical pharmacology timelines to assess portfolio opportunities. 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 teams, 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 all AbbVie projects along with CLINICAL PHARMACOLOGY management. Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions. Leads CLINICAL PHARMACOLOGY regulatory documents writing, submission and response to Regulatory agency comments.
* Independently conducts due diligence assessments, summarizes results and represents CLINICAL PHARMACOLOGY on business development teams.
* Identifies and develops process improvement initiatives and reviews recommendations with management for approval and sponsorship.
* Responsible for leading efforts to develop departmental goals. Makes strategic clinical PK/PD decisions for the department. Provides leadership on strategic clinical pharmacology and drug development.
* Manages personnel including development, mentoring, and effective delegation.
* 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.
Qualifications
Qualifications
* PhD with typically 9+ years of experience or PharmD with typically 11+ 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 Clinical Pharmacology, PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple complex projects
* Demonstrated leadership skills with broad scientific and business-related orientations
* Demonstrated project management skills such as scope management, progress tracking/driving as well as people and time management
* Key contributor to initiatives and advancement of CLINICAL PHARMACOLOGY
* 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
Additional Information
Applicable only to applicants
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