Global Trial Leader

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.
The Global Trial Leader (GTL) will have primary global accountability at the trial level within the Global Development (GD) organization. The GTL will provide 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 Standard Operating Procedures (SOPs) and regulatory requirements.
**Principal Responsibilities**
- Oversight of external service providers (ESP), including ESP contracts and budgets. In addition, this individual 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.
- Lead the cross-functional Trial Team (including GD and non-GD members) and collaborate with all trial team members, building the trial operational plan, in alignment with the organizational and the Therapeutic Area (TA) Clinical Team's objectives. Define risk mitigation strategies and ensure implementation thereof.
- Maintain oversight of the trial by taking an operational leadership role in a matrix organization, which 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.
- Identify risks and ensure 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 and approval of ESP contracts, change orders and ensure 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.
- Contract Research Organization (CRO) management, including initiation of selection process, Statement of Work (SOW) development, budget and change orders and oversight of all deliverables outsourced to the CRO.
- Build and update 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, ESP Oversight Plan, Filing and Archiving Plan.
- Participate in preparation for, Health Authority inspections and internal QA audits.
- Drive lessons learned initiatives at trial level during and after trial achievement completion. Develop subsequent issue resolution and process improvements as required.
- Strong interaction with the Therapeutic Area, other GD 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.
**Qualifications**
- A minimum of a Bachelor's or equivalent University degree is required, preferably in a scientific discipline (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- A minimum of 8 years of clinical trial experience within the Pharmaceutical industry or Contract Research Organization (CRO) is required.
- Experience in the Oncology Therapeutic Area is preferred.
- Clinical trial experience in Early Development and Late Development is preferred.
- An exploratory scientific mindset with focus on disease area and Pharmacokinetics/biomarkers is preferred.
- Experience with vendor management is required.
- Must have strong communication skills.
- Must have strong people leadership skills.
- The ability to lead all aspects of execution of a clinical trial is required.
- The ability to collaborate with all levels and influencing decision-making in a global, matrix environment is required.
- This position will require up to 20% domestic and international travel.
**Primary Location**
Brazil-São Paulo-São Paulo
- **Organization**
Janssen Cilag Farmaceutica Ltda. (7585)
**Job Function**
R&D
**Requisition ID**
W

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