Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Associate Director, Modeling & Simulation, Pkdm US

Expired Job

Sanofi Bridgewater , NJ 08807

Posted 3 months ago

Support clinical phase development project teams as a modeling and simulation (M&S) expert for the Pharmacokinetics, Dynamics, and Metabolism (PKDM) department:

  • Conduct translational and population PK, PK/PD analysis, exposure-response analysis, clinical trial simulation, PBPK analysis, and other model-based analyses

  • Formulate and execute PK/PD and M&S strategies for specific projects to inform dose selection and go/no-go decisions

  • Develop and review protocols, analysis plans, and study reports for M&S aspects

  • Prepare regulatory documents and representing M&S at regulatory meetings when needed

Knowledge and Skills
1.Develop the following scientific skills:

  • Perform translational and population PK and PK/PD analysis, exposure-response analysis, clinical trial simulation, and other model-based analyses independently under minimal supervision

  • Understand the strategic elements of drug development

  • Apply a logical and structured approach to file management

  • Develop departmental procedures (SOP's, Protocols, Safety Procedures)

  • Train/mentor others
    2.Demonstrate the following scientific competencies:

  • Serve as M&S representative for PKDM on development projects

  • Recommend a course of action to solve M&S issues

  • Act as a resource to address technical and theoretical issues in the M&S area

  • Be able to operate in a multicultural environment and participate in international teams

  • Prepare and issue stand-alone M&S reports with minimal review

  • Summarize documents for submission to regulatory agencies, including but not limited to the FDA and EMA

  • Can represent Sanofi to regulatory agencies

  • Prepare abstracts, posters and manuscripts for external presentation and/or publication

  • Identify skill-sets necessary to advance career development
    3.Ensure that all assigned project activities are performed in compliance with current departmental SOP's, guidelines, industry best practices and regulatory guidelines, and are conducted following acceptable scientific rationale.

  • Demonstrate excellent leadership

  • Possess excellent interpersonal communications skills commensurate with working in a multicultural organization

  • Independently accountable for meeting project timelines

Formal education and experience required:

  • Technical expertise in several of the following areas: translational and population PK and PK/PD modeling, exposure-response modeling, Clinical trial simulation, PK/PD modeling and simulation, PBPK modeling, drug-disease modeling

  • Proficiency with the use of one or more of the following software packages: NONMEM, R, SAS, Monolix, Matlab, Phoenix

  • Ph.D. with or without post-doctoral experience in pharmaceutical sciences, pharmacometrics, mathematics, statistics, computational biology, chemical/biomedical engineering, system pharmacology, computer science, or closely related discipline plus at least 6 years of industry experience with a record of increasing responsibility and independence

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SA

#LI-SA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Apply for role


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Financial Modeling Consultant Group Benefits

Metlife, Inc.

Posted 1 week ago

VIEW JOBS 12/6/2018 12:00:00 AM 2019-03-06T00:00 Job Location: United States : New Jersey : Bridgewater     Role Value Proposition:  Metlife’s finance organization is undergoing a transformation in financial reporting in order to facilitate more systematic and analytical reporting.  Group Benefits finance has played a key role in this effort.  As part of this team, you will partner closely with finance partners, business stakeholders and external consultants to coordinate the consolidation of multiple unit cost reports, with a primary focus on expense allocation analysis.  The Group Benefits Finance team is a diverse team of finance professionals, actuaries and accountants working together to improve the quality and analysis of our reporting.   Key Responsibilities: * Responsible for financial analysis of multiple unit cost reports, including Embedded Value and competitor benchmark studies. * Lead meetings with Group Benefits finance and business partners in support of updating and reviewing unit cost assumptions and results. * Manage and coordinate unit cost production schedules with Data Management team and oversee consolidation of unit cost data to ensure accuracy of reporting. * Manage development of Group Benefits Unit Cost Optimization Project, with a primary focus on process improvement and reporting efficiencies. * Create ad hoc financial models, attribution schedules and executive-level presentations, as needed. * Proactive individual who can identify and fix issues quickly and independently. * Experience with process improvement and lean principles.   Essential Business Experience and Technical Skills: Required: * Undergraduate degree required. * Minimum 5 years of financial experience; 2+ years of FP&A experience required. * Expertise in financial analysis. * Advanced Microsoft Excel and PowerPoint skills. * Proficient in Microsoft Access and Word.   Preferred: * Minimum of 5+ years FP&A experience is highly preferred. * Data Analytics - Comfortable working with and reviewing large amounts of data. * Experience with Hyperion financial system. * Insurance industry experience. * Bachelor’s Degree in Finance or Data Analytics. * MBA preferred.   Business Category Financial Management Group - Cross Portfolio Modeling   Number of Openings 1   At MetLife, we’re leading the global transformation of an industry we’ve long defined. United in purpose, diverse in perspective, we’re dedicated to making a difference in the lives of our customers. MetLife is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is MetLife's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. MetLife maintains a drug-free workplace. For immediate consideration, click the Apply Now button. You will be directed to complete an on-line profile. Upon completion, you will receive an automated confirmation email verifying you have successfully applied to the job. Requisition #: 103590 Metlife, Inc. Bridgewater NJ

Associate Director, Modeling & Simulation, Pkdm US

Expired Job

Sanofi