DIRECTOR, EVIDENCE LEAD, TOUJEO (DIABETES)

Finance / Accounting - Policy Underwriting DIRECTOR, EVIDENCE LEAD, TOUJEO (DIABETES)  Bridgewater New Jersey- EXP 2-5 yrs DEG Doctorate RELO BONUS Job Description.  Accountable for strategic and operational oversight of Health Economic and Outcomes Research (HEOR) studies to support the value propositions of our Toujeo therapeutic asset within the Diabetes HEOR group     Oversee Toujeo strategy development, as well as design, execution, and analysis of specific HEOR studies to create value messages that resonate primarily with payors, as well as patients and health care providers and other decision-makers; ensure the highest standards of excellence are applied to these studies – whether they be part of clinical trials, or independent prospective, retrospective, or real-world observational studies or health economic models, and that this is done in full compliance with us and regulatory requirements Planning/Initiation     Provide leadership, and oversight of HEOR plans (from development to execution) incl. statistical analysis plan, model specification outline/report etc. for Toujeo     Ensure alignment with Toujeo product / brand strategy, in close collaboration with matrix teams: V&A leads & Methods and Analytics     Ensure patients, providers, HTA perspective is included in HEOR and clinical plans, in particular via interaction with HTA bodies (i.e early scientific advices, pre-submission consultations, etc) in collaboration with V&A project team and relevant regions/key affiliates to ensure relevant data are generated, shared and align on interpretation   Execution     Drive execution of key HEOR Toujeo activities in collaboration with HEOR support functions, and regional / local HEOR when appropriate; partner with academics and external consultants as appropriate; guarantee the scientific and medical relevance / credibility     Ensure feasibility of translating evidence generated into real world effectiveness and cost effectiveness argument     Drive development of Core Value Dossier, from inception to dissemination and training to regions / affiliates     External opportunities assessment support might be needed Reporting for HEOR projects/deliverables for Toujeo     Share evidence with Toujeo V&A project subteam and regions/key affiliates at the V&A project subteam     Provide HEOR perspective and requirements to post-POC global project team for clinical development (DWG, IDC, ..) / trial design for Toujeo in collaboration with Value & Access function     Articulate and effectively communicate internally & externally Toujeo product value throughout its lifecycle to maximize impact of generated evidence as a binom with Toujeo V&A lead Communications     Responsible for the design of an HEOR Communication/Publication Plan for Toujeo asset with the objective communicate the unique attributes of Toujeo to external multi-stakeholders to ensure the drug’s value proposition will be recognized and hence market access and market uptake will be maximized   Qualifications       Advanced degree (PhD, MD, MPH, or PharmD) in a scientific discipline     Clinical background should be supplemented with advanced quantitative training demonstrated by an MPH or MS in a relevant field     Minimum of 5 to 7 years of combined experience in health economics, outcomes research, or directly market access field     Track record of publications in peer-reviewed journals demonstrating experience in PROs, observational research, and/or health economics     Thorough knowledge of global HTA processes and guidelines. Direct experience in making submissions to relevant payers and interacting with them is strongly desired (in US & Europe as a minimum).     Demonstrated capabilities to develop global strategic HEOR plans and execute studies     Diabetes experience or related therapeutic areas e.g. cardiovascular would be preferred.     Documented training in Health Economics desired     Proficiency in decision modeling and input into clinical trials     Proven scientific publication record     Experience with patient reported outcomes     Strong Project management experience  Skills & Competencies     English fluent, both written and oral     Broad knowledge of data analyses and health economic methodology     Comprehensive understanding of clinical development strategies and trial designs     Understanding of medical and statistical scientific methodology     Strong communication skills, both verbal and written, including presentation skills essential. Significant experience making presentations to senior management is strongly desired.     Results oriented and excellent analytic and collaboration skills     In-depth understanding of the legal and regulatory environment of the pharmaceutical industry, demonstrated integrity on work-related compliance considerations and solid ethics     Entrepreneurial and team spirit and ability to develop creative solutions to complex problems     Ability to manage complexity and ambiguity in a highly matrixed work environment     Self-motivated, acts autonomously and prioritizes  All your information will be kept confidential according to EEO guidelines. Direct Staffing Inc