Associate Director, Pharmacometrics
4 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
Purpose:
Conceives, executes and effectively manages and communicates multi-disciplinary modeling and simulations exercises to support development plans and strategies to achieve commercial goals and regulatory requirements for multiple functions. Generates new PK/PD modeling and simulation proposals and leads those efforts. Anticipates and critically evaluates Statistical, PK/PD, Clinical Pharmacology, or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies. Consistently demonstrates excellent record of accomplishment of Pharmacometric and business objectives. Leads Pharmacometric and PK/PD modeling aspects of multiple projects and indications. Responsible for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management.
Responsibilities:
* Executes 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).
* Author regulatory documents including analysis plans, study reports, population PK reports, exposure response analyses reports, label, white papers, and other similar documents.
* Present at various departmental and cross functional teams such as study teams, Clinical Pharmacology leadership team, Journal club.
* Drives small teams with members from Pharmacometrics functional groups to provide a unified modeling and simulation position to clinical, CMC and regulatory teams.
* Responsible for the appropriateness, quality and accuracy of pharmacometrics deliverables. Advice on complex methodologies such as advanced analytics, machine learning and mechanistic modeling
* Contribute to development of departmental goals. Influences strategic PK/PD decisions for the department.
* Champion development, implementation, and promotion of innovative PMx approaches across therapeutic areas.
* Participate in internal and external initiatives/working groups (e.g., cross-functional initiatives, process harmonization, IMI calls, ISoP groups).
* May manage personnel including their development, mentoring, and effective delegation.
* Authors scientific publications and present at national and international conferences and interact with external stakeholders
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications
* PhD with typically 5+ years of experience in a relevant field, Master's Degree or equivalent education and typically 11+ years of experience, Bachelor's Degree or equivalent education and typically 15+ 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 and externally and lead modeling and simulation teams
* 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 o Acts respectfully yet courageously.
* Connects unrelated concepts, generates original or unique ideas.
* Influences colleagues to achieve cross-functional alignment.
Additional Information
Applicable only to applicants
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