Program Delivery Leader, Xta Early Dev

il y a 6 jours

Antwerpen, Belgique Johnson & Johnson Temps plein

**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.

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