Clinical Research Director
Il y a 2 mois
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we, in France, are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”
**Janssen France is currently recruiting a Clinical Research Director (M/F) - Onco/Hemato.**
**Role based in Issy-les-Moulineaux (France - Paris area) on a permanent contract.**
**Position Summary**:
The Clinical Research Director is accountable for successful country execution of all phases of clinical trials within assigned therapeutic areas, including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. Supports Local R&D Head in shaping and managing local organizational structure to ensure its optimal efficiency. This individual is responsible for line management of Functional Managers, and/or other GCO staff, as required. Oversees staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the assigned therapeutic areas, country and GCO/ Global Development (GD) overall.
**Principal Responsibilities**:
- Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development / Interview, hire, develop and train staff / Provide coaching and mentorship as needed.
- Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
- Support the flexible resourcing model and collaborate with Flex Resource managers to get qualified staff in a timely manner, provide feedback on flex staff performance and support their on-boarding and off-boarding.
- Ensure understanding of relevant processes and procedural documents supported by documentation of direct reports’ training compliance, as required.
- Support direct reports in issue resolution and communication with involved stakeholders.
- Support local implementation of organizational changes and effectively communicate on priority shifts.
- Review and approve expenses in compliance with the company policies.
- Demonstrate leadership behaviors in alignment with J&J Leadership Imperatives / Foster an environment that encourages sharing of ideas, information, and best practices (internal and external to the organization).
- Define, execute or support of long-term strategy in alignment with GCO, GD and Janssen R&D strategies to position the local and global GCO organization for success.
- Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.
- Ensure relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
- Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct, and health care compliance breach. May contribute to CAPA and issue resolution in accordance with required timelines.
- Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs).
- Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other area of responsibility, as required.
- Oversight of robust feasibility process and site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals / Support regular metrics review and drive necessary follow-up actions.
- Contribute to development, evaluation and implementation of new processes and systems to improve study management.
- Ensure adequate quality oversight within assigned therapeutic area(s) and/or other area of responsibility, as required.
- Foster a culture of continuous improvement and innovation within the local GCO team. Model Credo based culture within the local GCO team.
**Qualifications**:
**EDUCATION & EXPERIENCE**:
Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Ch
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