Sr. Manager, Trial Deliver Leader
Johnson & Johnson
5 hours ago
Remote friendly (Spring House, PA)
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 DBL/CSR/TLR planning and scope; define protocol deviations and resolution pathways).
- Ensure trial deliverables and milestones are met.
- Identify risks; ensure mitigation and contingencies are initiated and followed through.
- Ensure trial is operationalized in compliance 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 and collaborate with R&D Quality for quality oversight.
- Participate in process improvement activities at a trial, compound, and cross-DU level as needed.
Additional Responsibilities May Include
- Lead and ensure inspection readiness for the program through risk identification and readiness review.
- Provide leadership during Health Authority inspections and at the program level for identified risks and mitigation plans.
- 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 (preferred: Life Sciences such as 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.
- Experience and knowledge of the pharmaceutical development process.
- Clinical research operational knowledge across multiple phases (Phase I–IV) and ability to manage all aspects of execution of a clinical trial.
- Excellent leadership skills; proven 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.
- Ability to operate and execute with limited supervision.
- Experience mentoring/coaching others.
- Strong project planning/management, communication, and presentation skills.
- Travel up to 15–20% as defined by 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 in the posting)
- Annual performance bonus (cash) based on targeted results.
- Eligible for medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Eligible to participate in pension and 401(k) savings plan.
- Time off: Vacation up to 120 hours/year; Sick time up to 40 hours/year (up to 56 hours/year for WA residents); Holiday pay up to 13 days/year; Work, Personal and Family Time up to 40 hours/year.
- Anticipated base pay range (US): $137,000 - $235,750.
Application / Posting Instructions
- This role may be posted under multiple requisition numbers by country; applications submitted under different requisitions will be considered as a single submission. (US: R-067822; UK: R-070509)
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 DBL/CSR/TLR planning and scope; define protocol deviations and resolution pathways).
- Ensure trial deliverables and milestones are met.
- Identify risks; ensure mitigation and contingencies are initiated and followed through.
- Ensure trial is operationalized in compliance 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 and collaborate with R&D Quality for quality oversight.
- Participate in process improvement activities at a trial, compound, and cross-DU level as needed.
Additional Responsibilities May Include
- Lead and ensure inspection readiness for the program through risk identification and readiness review.
- Provide leadership during Health Authority inspections and at the program level for identified risks and mitigation plans.
- 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 (preferred: Life Sciences such as 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.
- Experience and knowledge of the pharmaceutical development process.
- Clinical research operational knowledge across multiple phases (Phase I–IV) and ability to manage all aspects of execution of a clinical trial.
- Excellent leadership skills; proven 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.
- Ability to operate and execute with limited supervision.
- Experience mentoring/coaching others.
- Strong project planning/management, communication, and presentation skills.
- Travel up to 15–20% as defined by 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 in the posting)
- Annual performance bonus (cash) based on targeted results.
- Eligible for medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Eligible to participate in pension and 401(k) savings plan.
- Time off: Vacation up to 120 hours/year; Sick time up to 40 hours/year (up to 56 hours/year for WA residents); Holiday pay up to 13 days/year; Work, Personal and Family Time up to 40 hours/year.
- Anticipated base pay range (US): $137,000 - $235,750.
Application / Posting Instructions
- This role may be posted under multiple requisition numbers by country; applications submitted under different requisitions will be considered as a single submission. (US: R-067822; UK: R-070509)