Sr. Manager, Trial Deliver Leader
Johnson & Johnson
5 hours ago
On-site
San Diego, CA
Clinical Research and Development
Purpose
- Accountable for clinical trial delivery and operational oversight of cross-functional deliverables.
- Leads a cross-functional trial team to build and deliver the trial operational plan, identifying and mitigating risks to deliver assigned trials on time, on budget, and in a compliant manner.
You Will Be Responsible For
- Lead the Cross Functional Trial Team (CFTT) to influence and execute delivery of the operational plan and end-to-end trial execution.
- Own overall trial delivery, budget, timelines, quality, and milestones (including DBL/CSR/TLR planning and scope; define protocol deviations and resolution pathways).
- Proactively ensure trial deliverables and milestones are met.
- Identify risks and ensure mitigation/contingencies are initiated and followed through.
- Ensure trials are operationalized in compliance with global health authority regulations, guidelines, and internal operating procedures/processes.
- Identify risks in study conduct, develop mitigation plans, and escalate concerns to CT/CDT.
- Participate in Health Authority inspections and internal QA audits.
- Maintain inspection-readiness and collaborate with R&D Quality for quality oversight.
- Participate in process improvement activities at trial, compound, and cross-DU level as needed.
Additional Responsibilities May Include
- Lead and ensure inspection readiness for program through risk identification and readiness review.
- Provide leadership during Health Authority inspections and program-level risk/mitigation planning.
- Mentor and support onboarding of new team members (especially those in Trial Management).
- Foster employee engagement, inclusion, and Credo behaviors.
Qualifications/Requirements
- Education: Bachelor’s degree (Life Sciences preferred: Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum 8 years in Pharmaceutical, Healthcare, or related industries.
- Minimum 2 years’ experience leading multiple aspects of a global clinical trial.
- Knowledge of the pharmaceutical development process.
- Clinical research operational knowledge across Phase I–IV; able to manage all aspects of clinical trial execution.
- Excellent leadership skills; ability to foster team productivity and cohesiveness.
- Experience leading without authority in multi-functional, matrixed, global environments.
- Strong decision-making, analytical, and financial management skills.
- Able to operate with limited supervision.
- Experience mentoring/coaching others.
- Strong project planning/management, communication, and presentation skills.
- Travel up to 15–20% based on business needs.
Preferred Skills
- Budgeting; Clinical Trial Designs; Clinical Trials; Compliance Management; Consulting; Contract Management; Execution Focus; Fact-Based Decision Making; Give Feedback; Industry Analysis; Laboratory Operations; Organizing; Process Improvements; Project Integration Management; Research and Development; Research Ethics; Technical Credibility.
- Accountable for clinical trial delivery and operational oversight of cross-functional deliverables.
- Leads a cross-functional trial team to build and deliver the trial operational plan, identifying and mitigating risks to deliver assigned trials on time, on budget, and in a compliant manner.
You Will Be Responsible For
- Lead the Cross Functional Trial Team (CFTT) to influence and execute delivery of the operational plan and end-to-end trial execution.
- Own overall trial delivery, budget, timelines, quality, and milestones (including DBL/CSR/TLR planning and scope; define protocol deviations and resolution pathways).
- Proactively ensure trial deliverables and milestones are met.
- Identify risks and ensure mitigation/contingencies are initiated and followed through.
- Ensure trials are operationalized in compliance with global health authority regulations, guidelines, and internal operating procedures/processes.
- Identify risks in study conduct, develop mitigation plans, and escalate concerns to CT/CDT.
- Participate in Health Authority inspections and internal QA audits.
- Maintain inspection-readiness and collaborate with R&D Quality for quality oversight.
- Participate in process improvement activities at trial, compound, and cross-DU level as needed.
Additional Responsibilities May Include
- Lead and ensure inspection readiness for program through risk identification and readiness review.
- Provide leadership during Health Authority inspections and program-level risk/mitigation planning.
- Mentor and support onboarding of new team members (especially those in Trial Management).
- Foster employee engagement, inclusion, and Credo behaviors.
Qualifications/Requirements
- Education: Bachelor’s degree (Life Sciences preferred: Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum 8 years in Pharmaceutical, Healthcare, or related industries.
- Minimum 2 years’ experience leading multiple aspects of a global clinical trial.
- Knowledge of the pharmaceutical development process.
- Clinical research operational knowledge across Phase I–IV; able to manage all aspects of clinical trial execution.
- Excellent leadership skills; ability to foster team productivity and cohesiveness.
- Experience leading without authority in multi-functional, matrixed, global environments.
- Strong decision-making, analytical, and financial management skills.
- Able to operate with limited supervision.
- Experience mentoring/coaching others.
- Strong project planning/management, communication, and presentation skills.
- Travel up to 15–20% based on business needs.
Preferred Skills
- Budgeting; Clinical Trial Designs; Clinical Trials; Compliance Management; Consulting; Contract Management; Execution Focus; Fact-Based Decision Making; Give Feedback; Industry Analysis; Laboratory Operations; Organizing; Process Improvements; Project Integration Management; Research and Development; Research Ethics; Technical Credibility.