*This role will require someone to come on-site 3 days/week*
Communicates/presents key Pharmacometric modeling and simulation information/strategy to senior and executive management, regulatory agencies, and external peers. Supports 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 model and simulation as well as data analysis needs. Understands linkages across businesses and understands the impact of business decisions and solutions. May lead teams within Pharmacometrics and accountable for effective performance of the teams.
Looking for someone who desires to be hands on with data analysis and modeling exercises on a day to day basis while managing and monitoring a team.
Leads Pharmacometric/PK/PD modeling, simulation and reporting activities for multiple major projects. Assists Clinical Pharmacology senior management in the selection of action plans that best meets drug development business objectives.
Identifies issues and helps with issue resolution. Conducts risk assessments and assists in development of contingency plans. Assures project remains in alignment with strategic objectives.
Provides overall timelines to assess portfolio opportunities. Negotiates with Clinical Pharmacology senior management on project outcomes and deliverables to meet conflicting demands (time, cost, quality/performance).
Provides scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical decisions and development plans.
Responsible for 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 PK/PD report writing, submission and responses to regulatory agency comments.
Identifies and develops process improvement initiatives and reviews recommendations with management for approval and sponsorship.
Contribute to development of departmental goals. Influences strategic PK/PD decisions for the department.
Performs functions and responsibilities with the highest regard for quality and timeliness. Maintains up-to-date knowledge of PK/PD data analysis, modeling and simulation methods and software.
May manage personnel including development, mentoring, and effective delegation.
PhD with typically 7+ years of experience in a relevant field, MS or equivalent education with typically 14+ years of experience; BS or equivalent education and typically 17+ years of experience;(*relevant field includes experience with data science, mathematics, biostatistics, modeling and simulation, Pharmacometrics or systems pharmacology)
Excellent interpersonal skills
Knowledge and experience in multiple therapeutic and/or functional areas across range of development phases
Experience across range of development phases
Deep understanding of pharmaceutical drug development processes
• Must have demonstrated leadership competencies in Pharmacometrics, biostatistics, and PK/PD activities from planning, implementation through completion across multiple projects
Scientific project leadership or related experience
Project management skills such as scope management, progress tracking/driving as well as time management
Participation in initiatives and advancement of CLINICAL PHARMACOLOGY
• Prior people leadership experience preferred, but not required
Key Leadership Competencies:
o Knows the business and the cross-functional contributions needed to deliver results
o Persistent and resilient finds the way to move good ideas forward
o Acts respectfully yet courageously
o Connects unrelated concepts, generates original or unique ideas
o Influences colleagues to achieve cross-functional alignment
o Communicates openly and honestly with all colleagues
• Manages conflict and difficult conversations in a constructive transparent way
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.