J&J Family of Companies Global Program Leader, Investigator-Initiated and Collaborative Studies (Medical Affairs Operations) in Spring House, Pennsylvania
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Global Program Leader, Investigator Initiated & Collaborative Studies North America to be located in either Springhouse, PA, Titusville, NJ or Raritan, NJ J&J campuses.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires 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, LLC is part of the Janssen Pharmaceutical Companies.
Reporting to the MAO Global Development Operations Head (GOH), the MAO GPL is accountable for the successful planning, execution and reporting of assigned local, regional and/or global data generation activities within Investigator Intiated and Collaborative studies. This includes adequate resource planning and allocation; meeting deliverables within agreed timelines, budget, and with high quality per company procedures and regulatory requirements; as well as driving issue identification and resolution, contingency planning, and decision-making.
The MAO GPL acts as the single point of end-to-end accountability at the portfolio/program level. For the assigned portfolio/program, the GPL will manage relationships with global, regional and local Medical Affairs teams, R&D and other internal trial sponsors, as well as with other enterprise sectors, as applicable.
He/she will be responsible for the coordination of all activities within Global Development-MAO, (GD) functions, Development Management, Operations and Analytics (DMOA) and / or with any external service providers e.g. contract research organization (CRO).
The MAO GPL will lead a team of GD Trial Leaders (GTLs), Trial Managers (TMs) and G-Clinical Trial Assistants (G-CTA). Along with line management responsibilities, the GPL is accountable for managing and developing staff within his/her scope of responsibility to meet enterprise wide leadership standards for current and future employment opportunities while fostering a diverse work force that works seamlessly in a highly matrixed environment.
Single point of end-to-end accountability for the assigned portfolio/programs.
Drives the start-up of assigned portfolio/programs
Align on project strategy with the Medical Affairs team, R&D, and other internal trial sponsors, as well as with other enterprise sectors, as applicable.
Provide operational input in the design and implementation of the protocol (if applicable) including sourcing decision per the clinical operating model; either to be executed by GD or an external service provider, where applicable.
Discuss Clinical Development Plans Strategies and key operational questions with the GOH, as appropriate
Ensure GD or external service provider(s) is provided with the Protocol Design Elements/Protocol and critical operational elements in a timely fashion to allow optimal project preparation where applicable.
Drive the Request for Service (RFS) process; partnering with Global Clinical Operations (GCO); Integrated Data Analysis & Reporting (IDAR); and other GD functions as well as DMOA Centers of Excellence (COEs) such as Quantitative Sciences (QS), Pharmaceutical Development & Manufacturing Sciences (PDMS), and Clinical Forecasting & Analytics (CF&A) in the preparation and assumptions that make up the RFS. As applicable, compile project proposals via the Central Business Operations.
- Oversees the execution and close out of assigned portfolio/programs
Ensures effective budget management for all projects. Partner with the Functional Planning (FP) group for project related milestones and adequate resources. Ensures accurate trial budget management and reconciliation of all trials for both Out of Pocket (OOP) costs and FTE costs. Oversees Global Trial leaders (GTLs) and Trial Managers (TMs) in the overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
Monitor resource availability and ensure operational consistency across all activities of the Study Management Teams.
Promote optimal communication between the GTLs/TMs/G-CTAs and GD functions, internal trial sponsors, Global Medical Safety (GMS), Quality Management & Training (QM&T), Clinical Quality Assurance (CQA) and external service providers
Ensure timely status updates on project deliverables are provided to the Medical Affairs Team, R&D and other internal trial sponsors and/or other enterprise sectors, as applicable.
- Identifies and proactively manages issues in a timely manner.
Communicate regularly with the GOH on all issues and risks related to project resources, timelines and budget. Make recommendations for solutions and align with the GOH on the Action Plan.
Work with relevant project stakeholders and Study Management Teams to implement solutions/Action Plan.
Ensures that all project objectives are met according to all applicable regulations, legislations, guidelines and internal SOPs/policies.
Manages and supports training and development needs of direct reports to meet the enterprise wide leadership standards for current and future employment opportunities while valuing a diverse work force.
As applicable, acquires and sustains advanced knowledge of the appropriate Therapeutic Area, product and project setting.
Establishes strong relationships with the GOH and other Global Program Leaders within GD across all regions and Therapeutic Areas.
Decision Making Responsibilities:
Evaluates operational implications of clinical development plans and study design when appropriate.
Provides recommendations to GOH on project execution strategies and People Management-related topics.
Contributes to the design, development, and evaluation of the Clinical Operations processes and standards.
Principal Relationships: Both Internal and External Contacts
Bachelor’s Degree or equivalent required. Advanced Degree in a scientific discipline and/or Master Degree is preferred.
At least 8 or more years professional experience in clinical trials within a pharmaceutical company and/or a CRO required.
Expertise in the areas of drug development, clinical operations, strategic planning, and in-depth knowledge of Medical Affairs is preferred.
Sound clinical financial acumen; experience with managing budgets is required.
CRO management experience is preferred.
Full understanding of all logistical aspects when running clinical studies regionally and locally, and a good understanding of the therapeutic areas where J&J is involved required.
Experience in managing and mentoring clinical operations team members is strongly preferred.
Excellent people leadership skills in a matrix environment is strongly preferred, people management experience is strongly preferred.
Effective leadership skills and proven ability to foster team productivity and cohesiveness is required.
Excellent communication skills and the innate flexibility to work in a rapidly growing and highly matrixed organization is required.
Following skills to be considered further:
Trusted, inclusive, leader with demonstrated experience in managing/ mentoring global, cross functional matrix teams and a proven ability to foster team productivity and cohesiveness is strongly preferred.
Able to balance the customer needs and the business demands is required.
Ability to provide strategic leadership, proven decision-making skills, strong negotiating and conflict resolution skills is required
Excellent communication and influencing skills and ability to establish strong relationships in a global matrix environment as well as the innate flexibility to work in a rapidly growing and changing organization is required
In addition, the following competencies are required: collaboration and teaming, integrity and Credo based-actions, results and performance driven, sense of urgency, managing complexity, analytical skills, customer and external orientation is required.
Willingness and ability to travel up to 15-20% of the time, defined by business needs 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.
United States-New Jersey-Raritan-920 US Highway 202
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)