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SR AD, Pharmacometrics

Description:   The Sr. AD will perform high quality pharmacometric (PMx) analyses on a project and study level essential for internal decision making and successful approval with the support of their supervisor.  They will represent PMx in project and trial teams as well as author PMx documents and develop PMx strategy with the support of their supervisor.   As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.   Duties & Responsibilities: Ensure timely delivery of state-of-the-art PMx analyses for internal decision making throughout clinical drug development and registration (e.g., non-linear mixed effects models, model-based meta-analyses for dose selection, labeling, optimizing clinical study designs and pediatric development) Develop PMx strategy and clinical development plan, and implement model-informed drug discovery and development (MID3) in clinical development projects. Ensure timely delivery of PMx internal documents (e.g., dataset specification, PMx analysis plan, and PMx report). Ensure timely delivery of documents where PMx is co-author (e.g., clinical development plan, pediatric investigational plan, submission documents) Represent PMx in project teams (e.g. early clinical development team and medical sub team), and regulatory meetings. Represent PMx in internal and external initiatives/working groups (e.g., process harmonization, IMI calls, ISoP groups). Represent PMx in decision body meetings Organize and manage projects with external organizations (e.g., academic institutions or CROs) Continuously initiate improving the PMx IT infrastructure (e.g., specific code libraries). Continuously evaluate and implement novel PMx methods and approaches. Understand current national and international regulations, local requirements, BI policies and procedures as relevant to areas of expertise Apply this knowledge to ensure safe and compliant practices, manage risks, and maximize opportunities for projects to succeed Requirements: PhD from an accredited in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with two to nine (2-9) years of relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia OR;  Master's Degree from an accredited institution in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics or equivalent area of focus with a minimum of four to twelve (4-12) years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia OR; Professional degree from an accredited institution in pharmacy or medicine (e.g., PharmD, MD, Apotheker, Arzt) with a minimum of four to twelve (4-12) years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia.  Individuals with both a Master's degree and a Professional degree (as outlined above) will be considered with two to nine (2-9) years of experience (also as outlined above). Proficiency in applying PMx software (e.g., NONMEM, Monolix, R, SAS, PKSim, MATLAB, SimBiology) Basic knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory guidelines One to four (1-4) years of relevant experience in working in clinical teams is preferred. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required) Must be 18 years of age or older
Salary Range: NA
Minimum Qualification
Less than 5 years

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