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Program Delivery Leader, XTA Early Dev
Location:
Beerse
Description:
Position Summary The Program Development Leader (PDL) is accountable for the operational execution of the Clinical Development Plan (CDP). As a disease area thought partner, the PDL is responsible for the development of the program-level strategy and ensuring cross-functional alignment, identifying, and resolving program-level risks that may impact timelines or budgets. Major Duties & Responsibilities: * Responsible for the development of the program-level operational strategy and ensuring alignment across functions, Delivery Units and DAS areas / TA / portfolio (e.g., E2E connectivity from Global Development and non-Global Development partners, share lessons learned for program-level consistency, and monitor KPIs to track program-level success). * Accountable for the delivery of the operational strategy in alignment with the Clinical Development Plan, ensuring alignment with business goals and TA / clinical delivery and trial delivery objectives (including resourcing, budget, and change control, partnering with CDT sub-teams, timeline creation). Attend CDT and co-lead CT in collaboration with clinical leader. * Lead scenario planning and mitigate program-level risks that may impact timelines / budget, ensure appropriate quality oversight, and appropriately escalate issues on clinical teams and to CDT, Quality and functional leadership. * Ability to effectively communicate the operational strategy, and defend the operational plan and costs associated to CDT, TA leadership and at governance meetings (e.g TA governance, DC/IC) Other Duties * Leads and ensures inspection readiness for program through risk identification and readiness review. * Provides leadership during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues. * Support L&A activities when appropriate. * Mentor & support onboarding of new team members, particularly those in Trial Management. * Foster employee engagement, inclusion, and Credo Behaviors. Required Minimum Education: BS degree or equivalent Required Years of Related Experience: Minimum of 10 years' experience in the pharmaceutical industry. Required Knowledge, Skills and Abilities: * Experience in and knowledge of the pharmaceutical development process * Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage all aspects of execution of a clinical trial. * Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness. * Experience leading without authority and in muti-functional matrixed and global environments. * Excellent decision-making, analytical and strong financial management skills are essential to this position. * Operates and executes with limited supervision. Experience mentoring/coaching others. * Strong project planning/management, communication and presentation skills are required. Percentage Traveled: 15% - 20% (Domestic and International) People Management Experience: People management experience is highly preferred. Preferred Qualifications: Preferred Minimum Education: Advanced degree Preferred Area of Study: Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) Preferred Related Industry Experience: Pharmaceutical, Biopharmaceutical, Biotechnology Preferred Knowledge, Skills and Abilities: * Experience leading global clinical neurodegeneration programs/trials * Early clinical development experience Key Working Relationships: Internal: DAS Leaders, Trial Management Director, Clinical Trial Leaders, Clinical Trial Managers, Clinical Trial Assistants, Delivery Operations leaders, representatives of other GD Functions and Clinical Teams, GRA. External: Investigators, Patient Advocacy Groups, External Service Providers. Supervisory Responsibilities: Direct or Indirect Reports: None Decision Making Authority: * Recommends budget amounts. * Makes budget decisions.
Company:
Johnson And Johnson
Posted:
June 25 on Equest
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