Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
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The Senior Scientific Director of Quantitative Sciences (QS) will report to the Head of QS Consulting. As member of QS Consulting, the Scientific Director QS will be a resident expert on all aspects of model-based drug development and hands-on advisor on optimizing the development program strategy and supporting the selection of the right dose-regimen, in the right population, using the relevant biomarkers and the right endpoint by applying the optimal design to achieve differentiation. The candidate will be a core member of QSTEPS (QS Functional Governance Committee) and will perform consulting engagements with QS TALs (Therapeutic Area Leads), QS pMT (project Matrix Teams), CDT (Compound Development Team), and clinical teams working with the teams early on to provide quantitative solutions (options) on project problems, in support of decision making. The position will entertain strong interactions to opinion leaders beyond Janssen R&D, with a goal to represent QS and influence the external pharmaceutical industry and regulatory environment.
The Senior Scientific Director will: Mentor and advise colleagues from SDS (Statistics & Decision Sciences) and CPPM (Clinical Pharmacology and Pharmacometrics) to gain early alignment on scenarios of options QS pMT will develop and focus application of resource within SDS and CPPM to enable CDTs to achieve optimal decisions at the earliest time point in the most efficient manner; Assist QS pMT in supporting Scenario Analyses through simulation guided clinical trial design and the production of Simulation reports; Conduct methodological research and effectively apply state-of-the-art scientific/technical knowledge to own or assigned projects; Demonstrate considerable knowledge/expertise outside of own field, especially bridging disciplines; Introduce new approaches to solution of problems, process enhancements, and efficiencies; Keep up-to-date knowledge of model-unformed drug development (MIDD) and its implementation and innovative methods for preclinical, translational research and clinical trials, including population approaches, adaptive designs and pharmacometrics methods.
Additional responsibilities will include: Strategic planning and development of comprehensive talent management plan; Devising and implementing strategy for ensuring an integrated approach of the utilization of SDS and CPPM quantitative sciences methodology resource across the R&D portfolio, through close partnership with preclinical, clinical, operational and regulatory organizations; External collaborations, visibility, and impact; Engaging in external collaborations within professional associations (e.g., ASCPT, DIA, PhRMA, AAPS, ASA, EUFEPS); Leading and participating in working groups; Participating in program committees, organizing sessions and presenting at scientific meetings, and publishing in peer reviewed journals; Influencing the pharmaceutical industry and regulatory environments, by engaging in scientific advocacy working groups and committees; Helping advance the science in the field of Statistical Methodology, Pharmacometrics, and Model-Based Drug Development.
A PhD in Statistics or a related field and 15+ years of experience are required. Innovative approaches to statistical methodology and/or pharmacometrics in Biomedical Research are required. Basic knowledge of SAS and/or R Programming and software for modeling and simulation, (e.g. ADDPLAN, EAST, FACTS, NONMEM) are required. Leading expert in development and application of Statistical Methodology, Pharmacometrics, and MIDD to Pharm R&D is required.
Required experience includes: A thorough knowledge of the clinical development process and the commercial drivers of pharmaceutical markets; Extensive experience in drug development processes especially around leveraging pharmaco-statistical methodology, Bayesian and adaptive designs, MIDD, modeling and simulation, preferably in multiple TAs; Expertise and experience in providing strategic input in pediatric drug development plans, including extrapolation methodology; Established experience in reviewing and approving clinical development plans; A Strong understanding of the commercial and regulatory needs for relevant data generation; A strong and consistent track record of business results and strong execution that always results in meeting or exceeding goals and expectations; A history of exceptional and visionary and strategic leadership, ability to develop and foster scientific excellence and marry with portfolio imperatives and objectives; Ability to drive alignment around his/her vision and strategy across large organizations; Highly skilled in performing presentations, leading meetings and interacting with customers, employees and regulatory authorities; Outstanding leadership and management capability exemplified through clarity of goal setting, the ability to inspire others, to set a positive example by providing assistance, recognition and encouragement.
Additional requirements include: Demonstrated experience supervising and working in cross-functional/matrix groups; Strong influencing, oral and written communication skills; Ability to cultivate a high performance organization; ability to attract, develop, motivate and retain best in class talent aligned with the mission and goals of the new organization; Highly collaborative strong team player able to work across a highly matrixed global organization, cross-functionally and cross-culturally; Ability to effectively mentor and coach of others inside and outside their own immediate organization; Flexible and adaptable personality.
Travel up to 25% both domestic and international will be required.
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United States-New Jersey-Titusville-
Janssen Research & Development, LLC (6084)