Janssen Research and Development, L.L.C., a member of Johnson and Johnson’s Family of Companies, is recruiting for aData Delivery Leader - Associate Directorlocated in Spring House, PA, or Titusville, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science, wherever it might be found. We discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Visit http://www.JanssenRnD.com To learn more This position is an Associate Director level with professional experience.The Data Delivery Leader (DDL) Associate Director is responsible for managing all data management deliverables for one or more compounds of medium to high complexity in the oncology TA, and serves as the single point of contact and clinical team member for the R&D Company for data management.This position Independently makes decisions around timelines and budgets if they do not adversely impact the functions or the quality of the deliverables.The DDL proposes decisions to the functional leader around resource allocation within the project to ensure priorities are being addressed.Decisions that impact the resource allocations across projects should be referred to functional management for review.This position is instrumental in the decisions around choice of External Service Providers for data management activities.This position analyzes and provides analytic rationale to make decisions.The DML keeps functional leaders and data management specific area leaders informed of decisions. The DML develops and offers solutions to issues that arise on the project and implement the solutions. Other resources are at the DDL’s disposal for information or second opinions.The DDL provides input to performance reviews for team members and participates in the interview process for new hires.This position collaborates with functional management in make hiring recommendations, and development opportunities for GDMs.This DDL position requires a basic knowledge of data management tools and processes.Expert knowledge of project management tools and processes is required.This is a project management position focusing on data management, reporting directly to the Data Management Oncology Functional Leader (FL) .There are no direct reports, but matrix reporting through the GDM team.This position provides performance management feedback and guidance on development plans to the functional managers for the GDMs that are working on the programs.This position mentors DDL manager level positions.Serves as the data management point person to the clinical team of the respective R&D Company for each assigned compound; advises the team on DM strategies; keeps the team updated on the progress of DM milestones; negotiates for priority status and timeline adjustments as appropriate.Manages the DM timelines and budgets, ensuring milestones are delivered with quality, on time and within budget.Provides budget estimates for R&D Company business planning process.Partners with functional management to ensure proper resource allocation and training; negotiates for priority activities with the clinical team and the functions.Leads the data management working group for each compound as needed.Coaches and mentors team members and manager level DDLs, suggests development plans.Coordinates issue resolution activities across functions and implements solutions.Takes a leadership role in process improvement initiatives.Collaborates with third parties to develop compounds.Works with internal and external partners on indications of high complexity.Collaborates with internal cross-functional colleagues and external partners on the integration of multiple data streams for a program.Coordinates real time inspection readiness for all Data Management deliverables related to relevant compounds.Takes a leadership role for regulatory agency inspections and J&J internal audits as necessary.
QualificationsBS degree required, MS degree preferredA Life sciences degree is required8 Years of relevant experience is required, preferably in the Immunology area.Pharmaceutical or health care experience is requiredExperience with complex project management is requiredExperience in clinical drug development within the pharmaceutical industry or related industry is required.Experience in presentations, negotiations, and leading through influence is requiredExperience dealing with customers and leading teams to successful outcomes is requiredExperience in outsourcing and contract oversight is requiredWork on large or complex projects that are cross-functional is requiredTake a leadership role in identifying ways to reduce budgetary costs is preferredKnowledge of Electronic Data Capture (Medidata Rave) platforms required.In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) preferred.
We are an equal opportunity employer and value diversity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Primary LocationNorth America-United States-Pennsylvania-Spring HouseOther LocationsNorth America-United States-New Jersey-TitusvilleOrganizationJanssen Research & Development, LLC. (6084)Job FunctionClinical Data Management
Internal ID: 3630171029
Location/Region: Spring House, PA (US)