Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director Clinical Research located preferably in Spring House, PA, Raritan, NJ, Titusville, NJ, Leiden Netherlands South Holland, and/or Beerse, Belgium.
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.
- The GCDO Trial Leader (GTL) has primary global accountability at the trial level within the GCDO organization. The GTL is accountable and provides operational expertise for the successful cross-functional delivery of assigned global clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements.
- The GTL is accountable for oversight of external service providers, planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document (PED) to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results.
- The GTL is responsible for leading the cross-functional Trial Team (including GCDO and non-GCDO members) and interfaces with all trial team members, building the trial operational plan, is responsible for ESP contracts and budget, in alignment with the organizational and the Therapeutic Area (TA) Clinical Team (CT)’s objectives.
- The GTL provides global operational leadership to the execution to plan and defines risk mitigation strategies and ensures implementation thereof.
- The GTL maintains oversight of the trial by taking an operational leadership role in a matrix organization, while scientific leadership is provided by the Study Responsible Physician.
- This includes coordinating activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning, and decision-making.
- The GTL leads the cross-functional Trial Team; Tracking of Project Deliverables & Timelines using Functional Planning tools and support.
- Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs).
- Accountable for delivery of global trials within agreed/projected life of trial budget
- The GTL ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs.
- Is responsible for overall contract management, including review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered per contract.
- Ensures that environmental analysis, protocol feasibility and country & site selection process is conducted within timelines.
- Responsible to drive the final study placement, and ensure alignment with and communication to the involved stakeholders, including TA and RTAEs
- Develop the trial ESP strategy for his/her assigned trial in line with the overall program ESP strategy. Is accountable for oversight of all external service providers used for the trial for both in house and outsourced studies. Is responsible to ensure selection, and set up, including scope of work (SOW) and specifications are in line with protocol requirements, budget and timelines. During execution, the GTL will ensure escalated issues are appropriately resolved.
- For outsourced trials is responsible for CRO management, including initiation of selection process, SOW development, budget and change orders and oversight of all deliverables outsourced to the CRO.
- Ensures Trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
- Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits
- Ensures that the Trial Team operates in a constant state of inspection-readiness
- Ensures Trial Team members have received the appropriate trial-specific training needed for their function; in collaboration with the Study Responsible Physician (SRP), the GTL ensures appropriate trial-specific training is given to Trial Team members or to the CRO.
- Oversee the Clinical Trial Manager (CTM) in the set-up and coordination of Investigator Meetings, if applicable.
- Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the Trial Team and if they cannot be resolved within the function and/or Trial Team they are escalated to the GCDO Program Leader (GPL) and Clinical Team level, as necessary.
- Accountable to drive lessons learned initiatives at trial level during and after trial milestone completion; accountable for developing subsequent issue resolution and process improvements as required.
- Strong interaction with the Therapeutic Area, other GCDO functions, Clinical Supply Chain, Bioresearch Quality and Compliance Group, Clinical Business Operations, Finance, Project Management Organization, Regulatory and external partners to influence alignment on issues and decisions affecting trial management, enabling successful trial outcome.
- This position reports to the GPL. The GTL leads a matrixed cross-functional trial team, with minimal guidance from the GPL and provides feedback into performance of matrix team members.
- The GTL may be involved in coaching/mentoring of other GTLs and Trial Team members, as well as interviewing/selection process.
- The GTL does not have any direct reports.
- Cross-functional trial team members have a dotted line reporting project deliverables into GTL. GTL will assign trial related deliverables to trial team members
- You possess a Bachelor’s or higher degree, preferably in Life Sciences (e.g., Biology, Chemistry, Nursing, and Pharmacy)
- You have 8 or more year’s clinical trial experience in the pharmaceutical/ medical device industry and or CRO.
- You are able to lead all aspects of execution of a clinical trial and you demonstrate expertise in vendor management.
- You excel in organizing and motivating global or regional teams in a virtual environment.
- You are a coach and a mentor.
- Able to travel up to 20% of the time, (as defined by business need).
- Experience executing Phase II & III clinical trials
- Relevant experience in Pediatrics