Janssen Research & Development LLC, a Johnson & Johnson company, is recruiting for the Associate Director, Global Development Data Science & Digital Health . This position has a primary location of Titusville, NJ but it flexible to other Janssen R&D sites such as Spring House, PA; Raritan, NJ; South San Francisco, CA; San Diego, CA; and Cambridge, MA.

At Janssen R&D, the Data Science & Digital Health (DSDH) function is charged with applying cutting-edge analytic approaches such as AI/ML to drug discovery and development across Therapeutic Areas. The group drives and shapes both internal and external collaborations, working across Janssen’s Therapeutic Areas and R&D functions, including Global Development and other areas.

The Global Development, Data Science & Digital Health (GD, DSDH ) group within the JRD Data Science organization has the accountability for full scale impact across the Development pipeline via AI/ML-driven site recommendation trial design optimization, real-world evidence (RWE) generation, digital endpoints, decentralized trials, and external policy, with the key pillars being:

• Driving Trial Acceleration & Optimization using data science, including but not limited to:
• Enrollment modeling, feasibility analytics, country footprint expansion, advanced AI/ML modeling for predictive site recommendations
• Leverage real-world data for patient matching and enhancing Diversity, Equity, and Inclusion (DE&I) in clinical trials
• Protocol Design Optimization- evaluating and proposing options for eligibility optimization, hybrid trials, and decentralized clinical trials models
• RCT-RWD registries and implementation via data tokenization across the prioritized portfolio and other RWE innovations

The Associate Director, GD DSDH , leads the RWE innovation strategies and/or responsible for leading a Therapeutic Area or DAS/PAS with DS tools and methodologies, (i.e. RWD sources, historical operations data, AI/ML model, and more) to impact trial acceleration via benchmarking and clinical analytics to support the study planning and site selection process for the Janssen pipeline. Key areas of focus for Trial Acceleration include (not limited to) enrollment modeling, site selection, acceleration of site start up activities, patient eligibility matching to facilitate trial recruitment, and generation of patient data through Digital Health and RWE options.

The Associate Director, GD DSDH is responsible for the Manager, GD DSDH to coordinate the collection, aggregation, and analysis of data sets from cross-functional teams and data sources to provide scenario planning, enrollment projections, study enrollment progress modeling, and site recommendations. Additionally expected to balance team workloads, address program specific issues, and responsible for ensuring pull-through/ success rate of identified and activated sites from First Patient In (FPI) through Last Patient In (LPI).

Associate Director, GD DSDH partners with GD and TA Leads to identify categories of risk and opportunity to improve study/program optimization, including (not limited to): country start up timelines, enrollment trends, site productivity and impact of patient recruitment tactics. Leads the development and/or adoption of new technologies and platforms from design specification, build and roll-out. Additionally leads the resourcing and performance management of the Manager, GD DSDH and will report to the Director or Senior Director Global Development, Data Science & Digital Health, in JRD Data Science organization.

• Proactively and collaboratively lead the overall portfolio analytical strategy and handle the prioritization and resource allocation to optimally support the TA needs for feasibility and trial acceleration.
• May at times be responsible for planning, validating, and owning the correct and complete production of standard analytical packages from concept to delivery, including clinical team alignment, with agility to evolving study design.
• In partnership with the Manager, GD DSDH, proactively monitor enrollment trends and identify mitigation opportunities where needed. Work proactively and closely with the DS Analytics, Insights Delivery (AID) Team and other members of the DS team to integrate Incidence/Prevalence projections, Enrollment projections, Country/Site Footprint identification, and generate insights during Clinical trial feasibility process to deliver a data driven site list.
• Develop and communicate program/project plans, including and not limited to Gantt charts, PowerPoint presentations, timelines and other job aids to keep team organized and delivering.
• Drive and articulate insights and impacts through presentations and discussions with cross functional partners and their leadership.
• Ensure the analytics team is appropriately applying multiple DS tools and technologies available such as Med.ai, Trials.ai, (SIH, SEH, eSDL/Illuminator), Investigator overlap analysis, Patient Hotspotting, RWD DE&I Dashboard and more to impact the overall Country/Site recommendations for trial or portfolio to deliver an aligned and final approved Site Decision List.
• Accountable for leading analytical teams (internal and vendor teams) to deliver timely feasibility analytics, external/internal benchmarking, competitive landscape, country tiering, site profiles, and enrollment modeling to be incorporated into the larger trial acceleration strategies.
• Partner with GD, TA, Medical Affairs, CROs and any cross functional groups that are critical in settling overall strategy for protocol design, trial execution and site selection to make recommendations, address questions, and ultimately gauge impact to accelerate trial execution.
• Ensure timely progression of sites during from study start up to LPI, dashboard and report on clinical trial performance metrics such as trial placement, optimization, enrollment, and mitigation/intervention strategies.
• Drive the implementation of initiatives, processes, visualization , or technologies to optimize supply/demand, prioritization across the capabilities, improving productivity deliver insights.
• Drive the advancement department capabilities with analytic methodologies for operational insights and support continuous improvement, following and updating business processes, Work Instructions or SOPs.
• Define critical metrics and track efficiencies from the implementation of new technology initiatives related to study placement and enrollment tracking and contribute to lessons with peers
• Ensure delivery of requirement by CROs and technology partners to establish operational enrollment technology and business processes.
• Stay informed and bring industry trends within Therapeutic Area (TA)s, data analytics, and technologies.
• Partner with JRD Data Science TA, RWE, Data Platforms and Privacy (DPP) and others to understand and/or execute on lead and/or assist team for RWE based advanced analytics to support feasibility process.
• Advancement to Director level (in-role promotion) dependent on demonstrated mastery of above responsibilities.

Successful Outcomes for Associate Director, GD DSDH

• Lead team for successful and timely delivery of data insight generation, modeling tactics and operationalizing technology and analytical initiatives related to enrollment tracking, site list development and optimization
• Management of TA/DAS requirements: program parameters, timelines, risk tracking and team alignment.
• Effective collaboration and leadership with GD, DS and TA Partners on insights that should be considered and highlighted and to connect the data with application to trial operational design and efficiency.
• Guiding program planning, protocol design, country and site placement, and enrollment modelling applying data-driven approaches and influence optimized approaches to clinical trial execution.
• Support the Director/Senior Director, GD DSDH with program planning deliverables such as recruitment rates, site numbers, enrollment estimates, country footprint, startup timelines, impact of protocol criteria, and site and patient profiles.

Qualifications

• Minimum of a Bachelor’s or equivalent University Degree required; focused degree in Biology, Biochemistry, Microbiology, Chemistry or related field is preferred.
• 8+ years of proven experience in clinical trial start-up/execution, applied technology, or pharma /biotech industry business operations is required
• 5+ years Data Analytics experience with successful track record for driving large initiatives by generating agreement, handling complex projects, and delivering excellent quality analytics is required
• Experience in leading cross-matrix teams with proven track record to foster team productivity and cohesiveness.
• Strong and proactive partner engagements skills with ability to influence change, define new processes and establish new team norms .
• MS Excel advanced user or certified, with knowledge of modeling and analytical methodologies and visualization tools, including, (not limited to): Monte Carlo Simulation, Sankey Maps, mapping software.
• Experience in analytical and modelling tools, large data sets, and data analysis workflows with demonstrated fluency in statistical and analytical principles delivering robust, timely, high-quality analytics
• Ability to infer and apply data insights to optimize trial strategy and generate multiple scenarios based on business variables.
• Confident leading internal partnerships, external vendors and CROs with limited guidance, and leading navigating in new areas.
• Excellent verbal and written communication skills, with ability to deliver clear, and timely data and technology assessments to Feasibility and leadership team
• Solid understanding of the changing ecosystem of external data such as real-world data, and publicly available data assets that would benefit a clinical operations data science team
• Experience or understanding of benchmarking, data science and analytics, AI/ML, data analytics, clinical trial feasibility and data modeling.

Preferred

• People Management and Team Leader Experience
• Strong Project management and organizational skills with ability to lead and execute multiple projects simultaneously is highly preferred
• Experience using industry data sets: Healthverity, Komodo
• Expertise in clinical trial operational datasets such as CTMS and operational benchmarks
• Hands-on experience working with dataset in the clinical trial feasibility or acceleration models
• Experience with Integrated Site Analytics, Diversity and Patient Matching., and tokenization, and real-world models
• Knowledge of Healthcare delivery systems/networks in US and Key markets preferred.
• Experience in rare disease preferred

This position may require up to 15% domestic or international travel

This position has an expected base pay range of 180,000 - 220,000 USD

Thriving on a diverse company culture and celebrating the uniqueness of our employees, we are committed to inclusion. We are proud to be an equal opportunity employer.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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