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Global Clinical Development Operations Trial Leader, Oncology (1 of 2)
Requisition ID: 00001CNU
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Global Clinical Development Operations (GCDO) Trial Leader, Oncology (GTL) located in Spring House, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium; High Wycombe, UK; Leiden, South Holland; or Breda, Netherlands.
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.
We discover and develop innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Bring your talents to our mission, visit http://www.janssenrnd.com/ to learn more.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Global Clinical Development Operations (GCDO) Trial Leader, Oncology (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 early development clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements.
- Accountable for oversight of external service providers (ESP), including ESP contracts and budgets. In addition, he/she will be involved in planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document to availability of the Clinical Study Report 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 collaborates with all trial team members, building the trial operational plan, in alignment with the organizational and the Therapeutic Area (TA) Clinical Team’s objectives. The GTL 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; 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.
- Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of Corrective and Preventive Action Plans).
- Overall trial budget and contract management, including updates for scope changes, review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered.
- Drive the final study placement, and ensure alignment with and communication to the involved partners, including TA and regional GCO TA experts.
- Develop the trial ESP strategy for the assigned trial in line with the overall program ESP strategy.
- Responsible for CRO management, including initiation of selection process, SOW development, budget and change orders and oversight of all deliverables outsourced to the CRO.
- Builds and updates study-specific documents such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents, Safety related documents, Protocol Deviations and Issue processes, External Service Provider Oversight Plan, Filing and Archiving Plan.
- Participates in preparation for, Health Authority inspections and internal QA audits.
- Accountable to drive lessons learned initiatives at trial level during and after trial achievement completion; accountable for developing subsequent issue resolution and process improvements as required.
- Strong interaction with the Therapeutic Area, other GCDO functions, Biomarker groups, Clinical Pharmacology, 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.
- Bachelor of Science or University equivalent is required; preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
- Minimum of 7 years of clinical trial experience in the pharmaceutical industry or CRO is required
- Strong knowledge in Early Development clinical trials is highly preferred
- An exploratory scientific mindset with focus on disease area and PK/PD/biomarkers is recommended
- Relevant experience in the Early Development of one of more of Janssen’s Therapeutic Areas and/or healthy volunteer studies is preferred
- Ability to lead all aspects of execution of a clinical trial and you demonstrate expertise in vendor management is required
- Excellent people leadership skills in a global, matrix environment is required; people management experience is strongly preferred
- Willingness and ability to travel up to 20% of the time, defined by business needs is required
United States-New Jersey-Raritan
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Netherlands-North Brabant-Breda, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
Clinical Trial Coordination