Associate Director, Pharmacometrics - (Hybrid)

---

Job description

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

<!– job description page –>