Lead, Trial Delivery Manager Oncology

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at Oncology:

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-052335

United Kingdom - Requisition Number: R-053621

Belgium Netherlands Poland Spain Portugal Italy - Requisition Number: R-053618

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

We are searching for the best talent for Lead Trial Delivery Manager Oncology to be located in Lead Trial Delivery Manager to be located in High Wycombe United Kingdom.

Purpose:

The Lead Trial Delivery Management (TDM) is responsible for the execution of study-level activities creating and updating trial-specific documents vendor oversight & delivery compound training and other activities. The TDM is responsible for country and regional oversight of local operational delivery

including the alignment of the feasibility strategy and target setting risk reviews and local challenges that could impact overall study delivery.

Primary Responsibilities:

• Create and update critical trial-specific documents (e.g. Monitoring Guidelines Informed Consent Form Investigational Medicinal Product IMP related documentation).
• Manage vendor set up and management of day-to-day study vendor activities including set-up SOW creation and budget oversight.
• Responsible for country / regional coordination of trial management activities and oversight (e.g. aligns feasibility strategy with local teams perform country-level risk reviews aware of all projects conducted across countries).
• Support development of program-level compound training collaborating with Clinical / CTL&T / Medical writing.
• Provide input into trial level operational strategies.
• Resolve trial-related issues and mitigate trial-related risks.
• Participate in process improvement activities at a trial compound & cross-DU level as needed.
• Provide support during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
• Mentor & support onboarding of new team members particularly those in Trial Management.

Principal Relationships:

Internal: Trial Management Directors Clinical Trial Leaders Clinical Trial Assistants Representatives of Delivery Operations representatives of other GD Functions and Clinical Teams representatives of Procurement

External: Vendors

Qualifications / Requirements:

• BS degree or equivalent preferred areas of study include Life Sciences (Life Sciences (e.g. Biology Chemistry Biochemistry Nursing Pharmacy).
• Minimum of 4 years clinical trial experience in Pharmaceutical Healthcare or related industries.
• Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage multiple aspects of execution of a clinical trial.
• 2-3 years experience supporting multiple aspects of a global clinical trial.
• Minimum of 2 years of oncology clinical trial experience.
• CAR-T experience would be a plus
• 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.
• Operate and execute with limited supervision.
• Experience mentoring/coaching others.
• Strong project planning/management (e.g. organization problem-solving and adaptability) communication (e.g. effective communication with and managing expectations of stakeholders) and presentation skills are required.
• Ability to think strategically and work through ambiguous situations.
• Ability and experience to lead the Study Management Meetings.
• Experience and skills utilizing technology (e.g. tools systems with GenAI enabled capabilities) to obtain reports for efficient metric oversight.
• Travel up to 15-20% of the time defined by business needs.

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