Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, Early Development Clinical Program Management Leader (ED-CPML), Oncology to be located in Raritan, NJ or Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Research & Development, L.L.C. thrives on a diverse company culture, celebrates the uniqueness of our employees and is committed to inclusion. We are proud to be an equal opportunity employer.
The ED-CPML will report to the Oncology Project Management Organization (PMO) Therapeutic Area Leader (TAL) or designated line manager and will work closely with the ED Clinical Leader (CL) who is generally a physician in the Oncology Therapeutic Area (TA).
The Associate Director, Early Development Clinical Program Management Leader (ED-CPML), Oncology will:
• Maintain end-to-end oversight of the clinical program and its processes by taking an operational leadership role in the integration of activities in a matrix organization.
o Responsibilities include planning, executing, controlling and reporting on clinical development plans as well as coordination of activities with the cross-functional Clinical Team (CT), risk identification & mitigation, issue identification & resolution, contingency planning and facilitation of team decision making.
• Co-lead the CT where the Clinical Leader (CL) drives strategy and the CPML leads the team to operationalize that strategy (including scenario planning and setting priorities) to ensure all activities are aligned with the Compound Development Team (CDT) goals and objectives.
• At direction of ED CL, chair meetings and represents the ED CT at interdepartmental meetings, governance meetings, co-development partnerships, and external meetings such as HA or advisory meetings.
• Ensure documentation of CT meetings, key decisions and action items.
• Partner with cross functional leads (Global Clinical Development Operations, Clinical Supplies, Global Medical Safety, Finance, Regulatory, Biostatistics, etc.) in working groups at the clinical program and individual trial level to assure end-to-end trial oversight and to identify and mitigate issues in order to maintain quality, timelines, resources and budget.
• In collaboration with the Program Coordinator (PC) and Program Management Leader (PML), manage CT cross-functional communication (i.e. SharePoint) and program planning (i.e. V6), provide input into resource needs vs. availability and budget (i.e. Continuous forecasting).
• Contribute to the Program Management Team (PMT) meetings to plan, execute, control, report and close-out all clinical related work across all functions (e.g. integrated program budget, risk, timeline, resource, and stakeholder management)
• Partner with the PML, Finance and functional leads to forecast and manage the overall clinical budget on an ongoing basis
• In co-development programs, manage and align cross company clinical research activities and objectives.
• In collaboration with the clinical and regulatory functions, drive the planning and preparation of clinical documents required for successful Health Authority submissions.
• Utilize Team Development best practices and facilitates lessons learned to ensure optimal performance of the CT.
• Program and Strategic Planning
• Operations Management and Leadership
• Trial and Submission Management and Oversight
• Program Information/Communication Management
• Program Timeline, Resource, and Cost ManagementQualifications
• A minimum of a Bachelor’s degree is required
• An advanced degree (e.g. Master’s, PhD, etc.) in life sciences or related field is preferred
• A minimum of 10 years of pharmaceutical industry experience is required
• A minimum of 5 years of experience in clinical development is required
• A minimum of 5 years of experience in project management, and/or functional line management is required
• Oncology experience is required
• The ability to work with cross-functional teams in a matrix environment is required
• Professional project management certification (e.g. PMP) is preferred
• Early Drug Development experience is preferred
• Demonstrated experience managing or leading global and/or virtual teams, especially if done within a matrix organization is preferred
• Record of successful stakeholder management is preferred
• Advanced SharePoint technical skills is preferred
• Face-to-face availability for teams in Raritan, NJ and/or Spring House, PA including up to 10% domestic and international travel is requiredPrimary Location
United States-Pennsylvania-Spring HouseOther Locations
North America-United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function