Role Overview: Conceive, execute and communicate multi-disciplinary modeling and simulations exercises to support development plans and strategies to achieve commercial goals and regulatory requirements for multiple functions. Generate new PK/PD modeling and simulation proposals and leads those efforts. Investigate, identify, develop, and optimize new methods and techniques in the field of PK/PD modeling and statistical data analysis. Consistently demonstrates excellent record of accomplishment of Pharmacometric and business objectives. Leads Pharmacometric and PK/PD modeling aspects of multiple projects. Responsible for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management.
- Execute 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).
- Assist Clinical Pharmacology senior management in the selection of action plans that best meet business needs in drug development.
- Author regulatory documents including PK/PD analysis plans, study reports, population PK reports, exposure-response analyses reports, common technical documents, label, white papers, and other similar documents.
- Represent Pharmacometrics in Clinical Pharmacology and clinical project teams and presents in project team meetings and to Clinical Pharmacology Leadership.
- Develop, implement and promote innovative Pharmacometrics methodologies and approaches in multiple therapeutic areas.
- Collaborate with the Clinical Pharmacology TA leads to develop a unified Clinical Pharmacology position.
- Authors scientific publications and present at national and international conferences and interact with external stakeholders.
- Participate in internal and external initiatives/working groups (e.g., process harmonization, IMI calls, ISoP groups).
*NONMEM experience required.
- PhD with typically 3+ years of experience in a relevant field, Master’s Degree or equivalent education and typically 9+ years of experience, Bachelor’s Degree or equivalent education and typically 13+ years of experience;(*relevant field includes experience with data science, mathematics, biostatistics, modeling and simulation, Pharmacometrics or systems pharmacology)
- Excellent interpersonal skills
- Ability to interact with functional representatives internally
- 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
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.
Belangrijkste Werkzaamheden: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)