Clinical Trial Simulation Expert

Dear Friends and specifically those experienced in clinical trial simulation, Are you willing to make a change to do something exciting? Help create a climate for innovation and join the ranks of informed decision makers at Sanofi. We need you! This is an exciting opportunity for the right person. The details of the position are provided below but I'm happy to explain further for those who are qualified and interested. I'll be at the PAGE meeting . . . find me :) Jeff (contact via email is fine as well :) ) Vice-President, Interdiciplinary Pharmacometrics Program Global Head, Pediatric Clinical Pharmacology [email protected]<mailto:[email protected]> Senior Clinical Trial Simulation Expert (Senior Director) Description Summary of Role: The position of Senior Clinical Trial Simulation (CTS) Expert is a highly influential leadership role within Early and Late Development, Clinical R&D. This scientific and highly technical role provides a unique opportunity to set-up, develop and lead the field of clinical trial simulation across the global organization. The appointee will be responsible for all CTS (including pharmacokinetics and PK/PD) aspects of global projects at the early clinical stage (phase I) as well as those across all later clinical stages (Phase II à post-marketing) at Sanofi. The industry-experienced person undertaking this role will have strong and proven statistical and specifically clinical trial simulation knowledge, with demonstrable modelling and simulation skills, and will work in close collaboration with various non-clinical, Research, and Clinical R&D functions. The appointee will be required to ensure provision of CTS support to all R&D projects through the use of internal resources and external alliances, though undertaking hands-on modelling and simulation work on selected crucial projects will also be a requirement. This role will report to the Global Head of Biostatistics within Clinical Science & Operations (CSO) and will work alongside the Global Head of the Interdisciplinary Pharmacometrics Program (IPP), to lead and implement the CTS strategy for the portfolio. This role will also collaborate with project statisticians and / or pharmacometricians serving at a project and/or a study levels for CTS projects and will also coordinate interactions with senior-level external consultants or with academic institutions. RESPONSIBILITIES • Lead the implementation of CTS strategies in all global R&D projects as appropriate. Apply these strategies at a therapeutic area, as well as project, level. • Implement all necessary hardware and software systems, together with relevant quality processes, for the conduct of in-house CTS activities. • Lead the planning and execution of all relevant pharmacometric analyses: non-compartmental PK, PK/PD analyses, population PK and PK/PD, modelling and simulation methods, meta-analyses, disease and systems biology modelling. • Ensure the use of innovative analytical methods in pharmacometrics/modelling and simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states in support of optimal study designs and CTS. • Provide statistical contributions to regulatory documents including Investigator Brochures, Labelling and those required for regulatory meetings and regulatory filings. Provides resolution of biostatistical and/or pharmacometrics queries from regulatory agencies as necessary. • Writes, or leads the writing of, relevant sections of clinical study protocols, statistical analysis plans, and clinical study reports. Provides input for, or leads derivation of, standard operation procedures and best practices in biostatistics and/or pharmacometrics. • Develop external alliances with consultants, contract organizations and academic institutions to ensure timely conduct of all pharmacometrics deliverables for projects, to continually keep abreast of the science, as well as development of more junior colleagues in the discipline. • Input to licensing projects as needed. Qualifications Essential Qualifications/Experience: Qualifications Ph.D. in Statistics/Biostatistics (or equivalent statistical M&S experience) with demonstrated expertise in CTS and strong quantitative skills. Essential experience • A minimum of 15 years of pharmaceutical industry (or relevant) experience, specifically contributing to CTS aspects of clinical drug development. • Significant experience in the design and analysis of clinical trials • Thorough understanding of pharmacokinetics, PK/PD, population and modelling & simulation methodologies with related data interpretation, and general clinical pharmacology (including the design and conduct of clinical trials). • Ability to effectively collaborate, communicates, and influence throughout all levels of the organization. • Strong leadership abilities Essential Skills, Knowledge & Attributes: Technical Functional scientific knowledge, including: Essential Advantageous - In-depth knowledge and experience in advanced PK and PK/PD - Clinical pharmacology methods - Working knowledge and experience of software such as NONMEM, SAS, Monolix, and other server-based data processing and modelling tools - Programming experience with R or C++ - Knowledge of the role of pharmacometrics in drug development and FDA/ICH requirements for drug registration - Experience in endpoint modelling and disease progression modelling - Knowledge and application of statistics, random effects modelling, mixed effects modelling, data mining, population PK/PD analyses and modelling (including nonlinear models), Bayesian methods, clinical utility indices, and Monte-Carlo simulation - Interpretation of basic, safety pharmacology and toxicology data - Clinical trial design and simulation - PK and PD drug interactions, in vivo/in vitro models - Biopharmaceutics - Participation in full clinical pharmacology programs and in-depth understanding of full clinical development Regulatory and Quality Systems • Representation and pharmacometrics leadership at regulatory authority meetings • IND, CTA submissions • ICH Good Clinical Practice and Good Laboratory Practice • EMEA and FDA guidelines • Quality Control systems and processes for data analytical work to meet Regulatory requirements • In-depth knowledge of, and experience with global biostatistics and pharmacometrics regulatory requirements Communication and Interpersonal • Excellent communication skills with demonstrated ability to effectively present any aspect of this highly technical field, as well as its plans/strategies, accordingly to various audiences in both verbal and written form. • Proven ability to lead and mentor more junior statisticians and pharmacometricians. • Excellent oral presentation skills. • Ability to provide leadership in this discipline within the organization • Ability to create and communicate statistical and pharmacometrics plans/strategies. • Ability to create publications according to international scientific standards. • Good interpersonal skills, including a positive and constructive attitude and ability to effectively work in a team matrix environment. Negotiation and influential skills advantageous. • Experience working in multifunctional teams and ability to work collaboratively within matrix management environment.