Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Senior Global Feasibility Lead. This position can be located in Titusville, NJ, USA; Raritan, NJ, USA; Springhouse, PA, USA; Beerse, Belgium; or Leiden, Netherlands. Remote locations may be considered.
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. And we pursue the most promising science, wherever it might be found.
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.
The Director, Senior Global Feasibility Lead (GFL) will have primary accountability for Global Clinical Development Operations (GCDO) 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 Senior GFL will lead and facilitate the global (end to end) feasibility process at program / study level within one or more Therapeutic Areas (TA) and will be the primary contact with study team stakeholders at the central, regional and country level for in-house and outsourced resourced trials. The role may oversee larger, more complex projects and provide project oversight and direction to other GFLs assigned to the team. 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. Ensure feasibility execution for insourced and outsourced programs.
- Facilitate / lead feasibility activities across functions involved in the process working closely with the Global Program Leader (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.
- Provide updates on feasibility process to study and program team stakeholders including escalation 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 provide study feasibility strategic direction to facilitate local insights 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 effectively communicate key feasibility insights to influence and inform protocol development, study timelines, operational plans, country and site selection and help inform recruitment and patient recruitment strategies.
- Ensure consistent standards are applied for the feasibility process across portfolio of projects.
- Initiate and lead global feasibility continuous improvement efforts and initiatives.
- Take on Feasibility process ownership or Subject Matter Expert (SME) role.
- Support other GFLs by providing advice / consultation for complex or large programs.
- Collaborate with Feasibility Group Lead to develop and implement TA-aligned strategies / approaches for feasibility insights generation.
- Implement the agreed country engagement strategy / feasibility tactics aligned with the clinical development plan and trial program footprint for each stage of the feasibility process.
- Interrogate 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 POC.
- Collate and analyze data and insights from data analytics team / process and country level insights to develop global understanding of feasibility outputs and develop concise recommendations. Present overall feasibility insights summary, key questions and recommendations to study team.
- Deliver robust and consistent package of data / insights at each stage of the feasibility process to support decision making.
- Maintain continuity connecting and documenting changes from Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, to Recruitment and Start-Up Planning.
- Lead the process of setting the trial baseline commitments for site initiation and recruitment expectations and ensure that country and study level commitments are agreed at GCDO level then with TA.
- Facilitate the study baseline commitment change process (country and study levels).
- Support clinical operation roles in ensuring effective scenario generation and planning, comparing past performance data and proposed scenarios.
- Support 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 milestones.
- Provide early feasibility information leveraging existing data sources and organizational knowledge/expertise.
- Serve as a mentor for GFL role.
- Exhibit a continuous improvement approach to streamline appropriate processes for maximum efficiency and productivity.
- Provide leadership and facilitation to global feasibility process across matrix team.
- Leadership of large / complex programs.
- Communicate key project information and expectations to study team members including the country teams.
- Consolidate and present recommendations / key considerations from feasibility process and derived insights.
- Support development of operational plans with consideration of time, cost and quality.
- A minimum of a Bachelor’s degree is required. Advanced degree preferred.
Experience and Skills:
- A minimum of 8 years of experience in Clinical Operations, Data Analytics or other related area is required.
- Experience designing and developing functional capabilities through process design and effective staff training approaches is required.
- Project management experience is required.
- Must have excellent communication, presentation and interpersonal skills.
- Must have strong critical reasoning and analytical problem-solving skills, including the identification and resolution of complex problems and team leadership challenges.
- Must have the ability to proactively manage operational risks.
- The ability to manage functional budgets and assess study budgets required.
- The ability to leverage, interpret, explain, represent, and drive unbiased data insights into clinical trials operational planning is required.
- The ability to collaborate with all levels of management and influence decision-making in a global, matrix environment is required.
- People management experience is preferred.
- Experience overseeing and leading a regional or global team and managing staff in remote locations preferred.
- Extensive experience in the planning and execution of global sponsored clinical research in the pharmaceutical or Contract Research Organization (CRO) environments preferred.
- Knowledge of the processes associated with study/site feasibility, study management, monitoring, clinical and regulatory operations is preferred.
- Knowledge of Good Clinical Practices (GCPs) preferred.
- Experience in clinical research, including clinical trial conduct is preferred.
- Knowledge of the clinical trial process, including regulations, study design, feasibility, start-up, business operation, closeout and the associated supportive vendors and technologies preferred.
- Knowledge of sponsored clinical research study phases and study design principles preferred.
- Experience managing multinational clinical trials is preferred.
- Experience in assessing patient recruitment needs and building patient recruitment strategies for programs preferred.
- Knowledge of drug development is preferred.
- Feasibility experience is preferred.
- This position can be located in Titusville, NJ, USA; Raritan, NJ, USA; Springhouse, PA, USA; Beerse, Belgium; or Leiden, Netherlands. Remote locations may be considered.
- This position will require up to 25% domestic and international travel.
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.
United States-New Jersey-Titusville-
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC (6084)