Managed Access Associate Director GCDO Trial Leader
Multiple Locations: Beerse, Belgium; Leiden, Netherlands; Issy Les Moulineaux, France; Warsaw, Poland
Functions: Clinical Trial Coordination
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Requisition ID: 1905779172W
Janssen is recruiting for an Associate Director GCDO Trial Leader in Managed Access within Medical Affairs Operations, located in Belgium, The Netherlands, France or other central locations in Europe.
At Janssen, we believe it is our ethical obligation to provide access and care to patients in need. Managed Access is the provision of an investigational product, outside of a clinical trial, to treat patients with serious/life threatening diseases or conditions, where there exists no alternative treatments or where alternative treatments have been exhausted. The Managed Access team within GCDO Medical Affairs Operations (MAO) are responsible for the operational planning, management and execution of all Managed Access initiatives globally including Pre-Approval Access and Post-Trial Access programs. By flawlessly managing Managed Access requests and providing access to investigational treatment that are not yet approved for use by health authorities we give new hope to people in need.
* The Managed Access Associate Director GCDO Trial Leader (MAc AD GTL) MAO is accountable for the successful planning, execution and reporting of Managed Access initiatives in assigned therapeutic areas (TAs). This includes adequate resource planning and allocation, meeting deliverables within agreed timelines, budget, and with high quality per company procedures and regulatory requirements.
* For the assigned TAs, the MAc AD GTL MAO will manage relationships with Compound Development Team Leads, global, regional and local Medical Affairs teams and other internal and external groups, as applicable.
* The MAc AD GTL MAO is responsible for ensuring that global, regional and local projects have end-to-end MAc GTL oversight, that operational leadership is provided to the project teams and ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, prioritization, and decision-making.
* The MAc AD GTL MAO may act as a line manager, responsible for performance management, coaching and development planning
* Bachelor's degree or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Experience and Skills:
* 8 years of Managed Access or clinical trial experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.
* Clinical operations knowledge, project management and proficient communication skills are required.
* Effective leadership- and influencing skills and ability to build strong and trustful partnerships both internally and externally.
* Proven ability to foster team efficiency and cohesiveness. Flexibility and ability to manage global or regional teams in a virtual environment are needed.
* Excellent decision-making skills and ability to think out of the box
* Excellent knowledge of English
* International travel up to 10%
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-France-Haute-de-Seine-Issy Les Moulineaux, Europe/Middle East/Africa-Poland-Mazowieckie-Warsaw
Janssen Pharmaceutica N.V. (7555)
Clinical Trial Coordination