Sr. Manager, Trial Deliver Leader
Johnson & Johnson
5 hours ago
Remote friendly (Titusville, NJ)
United States
Clinical Research and Development
Purpose
The Sr. Manager, Trial Delivery Leader (TDL) is accountable for clinical trial delivery, providing operational oversight of cross-functional deliverables. The TDL leads a cross-functional 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 support for DBL/CSR/TLR planning and scope; define protocol deviations and resolution pathways).
- Proactively ensure trial deliverables and milestones are met.
- Identify risks; ensure mitigation and contingencies are initiated and followed through.
- Ensure trial operationalization complies with global health authority regulations, internal operating procedures, and processes.
- Identify risks in study conduct, develop mitigation plans, and escalate concerns to CT or CDT.
- Participate in preparation for and conduct of Health Authority inspections and internal QA audits.
- Maintain inspection-readiness in collaboration 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 program inspection readiness via risk identification and readiness review.
- Provide leadership during Health Authority inspections and at the program level for risks and mitigation plans.
- Mentor and support onboarding of new team members (particularly those in Trial Management).
- Foster employee engagement, inclusion, and Credo Behaviors.
Qualifications / Requirements
- Education: Bachelor’s degree (preferred Life Sciences: 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; ability to manage all aspects of clinical trial execution.
- Excellent leadership; proven ability to foster team productivity and cohesiveness.
- Experience leading without authority in multi-functional matrixed and global environments.
- Strong decision-making, analytical, and financial management skills.
- Ability 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.
Benefits / Compensation (as stated)
- Anticipated base pay range (US): $137,000 – $235,750.
- Annual performance bonus eligible (cash bonus; at company discretion).
- Company sponsored benefits may include medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Retirement/savings plan eligibility: pension and 401(k).
- Time off benefits: Vacation up to 120 hours/year; Sick time up to 40 hours/year (up to 56 hours/year for Washington residents); Holiday pay up to 13 days/year; Work/Personal/Family Time up to 40 hours/year.
Application instructions
- This role may be posted under multiple requisition numbers; applications are considered as a single submission when applying to one or more postings.
The Sr. Manager, Trial Delivery Leader (TDL) is accountable for clinical trial delivery, providing operational oversight of cross-functional deliverables. The TDL leads a cross-functional 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 support for DBL/CSR/TLR planning and scope; define protocol deviations and resolution pathways).
- Proactively ensure trial deliverables and milestones are met.
- Identify risks; ensure mitigation and contingencies are initiated and followed through.
- Ensure trial operationalization complies with global health authority regulations, internal operating procedures, and processes.
- Identify risks in study conduct, develop mitigation plans, and escalate concerns to CT or CDT.
- Participate in preparation for and conduct of Health Authority inspections and internal QA audits.
- Maintain inspection-readiness in collaboration 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 program inspection readiness via risk identification and readiness review.
- Provide leadership during Health Authority inspections and at the program level for risks and mitigation plans.
- Mentor and support onboarding of new team members (particularly those in Trial Management).
- Foster employee engagement, inclusion, and Credo Behaviors.
Qualifications / Requirements
- Education: Bachelor’s degree (preferred Life Sciences: 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; ability to manage all aspects of clinical trial execution.
- Excellent leadership; proven ability to foster team productivity and cohesiveness.
- Experience leading without authority in multi-functional matrixed and global environments.
- Strong decision-making, analytical, and financial management skills.
- Ability 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.
Benefits / Compensation (as stated)
- Anticipated base pay range (US): $137,000 – $235,750.
- Annual performance bonus eligible (cash bonus; at company discretion).
- Company sponsored benefits may include medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Retirement/savings plan eligibility: pension and 401(k).
- Time off benefits: Vacation up to 120 hours/year; Sick time up to 40 hours/year (up to 56 hours/year for Washington residents); Holiday pay up to 13 days/year; Work/Personal/Family Time up to 40 hours/year.
Application instructions
- This role may be posted under multiple requisition numbers; applications are considered as a single submission when applying to one or more postings.