Job Description

Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies is recruiting for a Global Feasibility Lead (GFL) is located in Titusville, NJ., but will consider remote candidates living anywhere in the United States, Netherlands, Belgium or Brazil.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease encourages us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, L.L.C is part of the Janssen Pharmaceutical Companies.

The Global Feasibility Lead (GFL) has primary accountability for GD program and study level clinical trial feasibility delivery. The scope of the position includes R&D trials including early development, late development, and phase 3b / IV interventional trials. The GFL leads and facilitates the global (end to end) feasibility process at program / study level within one or more therapeutic areas (TA) areas and is the primary contact with study team partners at the central, regional and country level for inhouse and outsourced resourced trials. The Global Feasibility Lead (GFL) is accountable for the successful delivery of feasibility activities (strategy, plans, activities, timelines, synthesis of feasibility insights and presentation to study teams) for all clinical programs assigned. Successful delivery means within timelines and with good quality that support operational planning / decisions resulting in predictable delivery. This position is accountable for ensuring feasibility execution for insourced and outsourced programs.

Principal Responsibilities:

Facilitates / leads feasibility activities across functions involved in the process working closely with the GPL to design and present recommendations to study team leads within defined timelines
Partner with study team members, country teams (country point of contact - POC) and the feasibility insights and data analytics team to design and conduct global feasibility activities on time with high quality delivery
Provides updates on feasibility process to study and program team partners including customer concern of key issues, risks, and recommended solutions to address
Ensure country POCs have relevant TA clinical development plan information (asset development timelines, timeline changes, development strategy, trial risks etc.) and provides study feasibility strategic direction to facilitate local insight's creation / feasibility completion
Support clinical operations roles early in the development cycle providing initial enrollment timelines, High Level Budget (Op Plan), potential Country Footprint, develop key assumptions, and establish patient recruitment strategy
Leverage and optimally communicate key feasibility insights to influence and inform protocol development, study timelines, operational plans, country, and site selection and help advise recruitment and patient recruitment strategies
Ensures consistent standards are applied for the feasibility process across portfolio of projects
Follows feasibility business processes and supports continuous improvement activities
Collaborates with Feasibility Group Lead to develop and implement TA-aligned strategies / approaches for feasibility insights generation
Implements the agreed country engagement strategy / feasibility tactics aligned with the clinical development plan and trial program footprint for each stage of the feasibility process
Interrogates insights / data provided from data analytics team and the countries at different stages of the process to identify regional or country disparities then resolve these with country
Collates and analyzes data and insights from data analytics team / process and country level insights to develop global understanding of feasibility outputs and develop concise recommendations. Presents overall feasibility insights summary, key questions and recommendations to study team
Operational responsibility for delivering robust and consistent package of data / insights at each stage of the feasibility process to support decision making
Maintains continuity connecting and documenting changes from Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, to Recruitment & Start Up Planning
Leads the process of setting the trial baseline commitments for site initiation and recruitment expectations and ensures that country and study level commitments are agreed at GD level then with TA
Facilitates the study baseline dedication change process (country and study levels)
Support clinical operation roles in ensuring effective scenario generation & planning, comparing past performance data and proposed scenarios
Supports development of systems, processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility (country, site) as well as the timing of key recruitment achievements
Provides early feasibility information leveraging existing data sources and organizational knowledge/expertise

Principal Relationships:

Contacts inside the company may include:
Global Program Lead (GPLs), GOHs, GTLs, GCO Country Managers/Heads, Clinical Research Manager (CRM)/Functional Manager (FM), Local Trial Manager (LTM), Site Manager (SM), Feasibility Staff, IPE staff, Therapeutic Area functions and Clinical Team members, medical affairs teams

Contacts outside the company may include:
Investigational Sites, Key Opinion Leader (KOLs), Advisory Board Members, Patient Engagement Groups, Academic Centers, vendors with focus on study placement, recruitment & retention capabilities

Qualifications
Minimum of a Bachelor's degree is required
6+ years' experience in Clinical Operations OR other RELEVANT experience - such as data analytics is required
Ability to strongly leverage, interpret, explain, represent, and drive unbiased data insights into clinical trials operational planning is required
Ability to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate, and lead within a global matrixed team is required
Ability to partner and influence without authority with leaders at all levels globally and locally is required
Ability to explain data, facilitate decision making processes to be data driven is required
A broad-based experience clinical research, including clinical trial conduct, Knowledge of GCP and a good understanding of the processes associated with study / site feasibility, study/project management, monitoring, clinical and regulatory operations is required
Experience of managing multinational clinical trials is preferred
Experience in assessing Patient Recruitment Needs and building patient recruitment strategies for programs is preferred
Knowledge of Drug development, a thorough understanding of the processes associated with Feasibility, clinical study start-Up and business operations is required
Demonstrated knowledge of clinical research processes and regulatory requirements of Demonstrated ability to manage complex projects and cross-functional processes required
Demonstrated platform skills; experience presenting to large non-science populations is required
Well-developed strategic planning, observation, analytical operational execution, and problem- solving skills is required
Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict is required
Significant experience in the specific Therapeutic analytics area assigned is preferred
Willingness to travel regionally/globally up to 25% is required

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

Primary Location
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Other Locations
Europe/Middle East/Africa-Netherlands, Latin America-Brazil, North America-United States, Europe/Middle East/Africa-Belgium
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D;
Requisition ID
2105903895W