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Program Delivery Leader, XTA Early Dev - 2406191520W

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.

Qualifications

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.

Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Other Locations Asia Pacific-Japan, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Switzerland-Basel-City-Basel, NA-US-Pennsylvania-Horsham, Asia Pacific-China, Europe/Middle East/Africa-Ireland, NA-US-Pennsylvania-Spring House, NA-US-California-La Jolla, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, NA-US-Florida-Titusville, Asia Pacific-Singapore, NA-US-New Jersey-Raritan

Organization Janssen Pharmaceutica N.V. (7555)

Job Function Clinical Trial Project Management

Req ID: 2406191520W