Director Clinical Innovation, Strategy and Operations
Locations: Beerse, Belgium
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Requisition ID: 1805699024W
Director Clinical Innovation, Strategy and Operations - Translational Medicine / Infectious Diseases Therapeutic Area
By optimizing the time of intervention Janssen Infectious Diseases (ID) is intent on finding the best patient value for new antiviral treatments in early childhood respiratory infections such as respiratory syncytial virus (RSV).
The strategy will allow early patient engagement and assessment by harnessing digital tools and other innovation in diagnostic technologies and social science tools. To evaluate the benefit of such patient path of early intervention and provide a proof-of-relevance during clinical development, Janssen ID Translational Medicine has developed new clinical designs focusing on effective recruitment before disease in combination with digital tools for information gathering and caregiver mobilization.
Janssen ID Clinical Development will perform dedicated studies where it will combine novel patient recruitment clinical designs with a phase II evaluation of lead antiviral compounds for RSV disease. In this study the experience gained by Janssen ID Translational Medicine on newly defined operational, regulatory and cost-efficiency evaluation elements will be integrated in a study setting with therapeutic intent.
There is an urgent need to identify an individual to co-lead these studies together with the medical leader and be accountable for overall budget and project plan deliverables.
Beyond co-leading these studies he/she is also expected to provide expert support to the Clinical Development group and the ID therapeutic area on the operational and cost value levers of investments in exploratory, pilot and proof-of-relevance studies for early intervention and the integration of new tools through various business interfaces with new technology providers.
Finally, he/she will lead the Translational Research Program Management Team which ensures - through interactions with relevant stakeholders - operational effectiveness within budget and resources constraints to deliver on the Translational Medicine / Translational Biomarkers portfolio.
Experience and competencies required:
* Advanced degree in life sciences or business (M.A., M.S., Ph.D., M.D., MBA) with at least 15 years of experience in a research-driven pharmaceutical company or clinical research organization.
* Evidence of having led the successful implementation of multi-site interventional studies within a cross-functional matrix involving global clinical operations and allied support functions.
* Experience in the active design, implementation, conduct and the business impact management of innovative exploratory clinical designs using digital tools for patient assessment.
* Experience in driving tactical delivery of new healthcare/health industry initiatives and collaborations with a focus on new digital tools for patient recruitment and assessment.
* Strong business orientation driving multi-year experience in resource and budget management.
* Proven project planning and tracking skills with a clear demonstrated ability for strategic thinking and contingency planning.
* A solution-focused mindset to enable application of innovative clinical approaches while managing compliance with essential company and regulatory processes and policies.
* Demonstrated ability to distill complex matters to their essence and translate into clear decisions combined with solid influencing, negotiation and conflict resolution skills to
* drive collaboration and transparency across all functions.
* facilitate lessons learned for reaching optimal implementation in subsequent iterations of the adopted development innovations.
Janssen Pharmaceutica N.V. (7555)