Senior Manager, Trial Delivery Leader

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Spring House, Pennsylvania, United States of America

Job Description:

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 https://www.jnj.com/innovative-medicine

We are searching for the best talent for Senior Manager, Trial Delivery Leader.

Please 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):

US: Requisition Number: R-1002001

EMEA- Requisition Number: R-103345

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

This is a remote role available in all cities within the USA While specific

cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Position Summary:

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 trial team to build and deliver the trial operational plan, identifying and mitigating risks to effectively deliver assigned trials on time, on budget and in a compliant manner.

Principal Responsibilities:

• Responsible for leading the Cross Functional Trial Team (CFTT) to influence and execute delivery of the operational plan and for end-to-end trial execution.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL / CSR / TLR planning and scope, define protocol deviations and resolution pathways).
• Proactively ensure that trial deliverables and milestones are met.
• Identify risks and ensure mitigation and contingencies are being initiated and followed through. • Ensure trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
• Accountable for identifying risks in study conduct, developing mitigation plans and escalating concerns to the CT or CDT.
• Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits.
• Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight.
• Participate in process improvement activities at a trial, compound & 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 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.
• Foster employee engagement, inclusion, and Credo Behaviors.

Principal Relationships:

Internal: DAS Leaders, Trial Management Directors, Clinical Trial Managers, Clinical Trial Assistants, representatives of Delivery Operations, representatives of other GD Functions and Clinical Teams

External: Investigators Education and Experience Requirements: Required Minimum

Education:

BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)

Required Years of Related Experience:

Minimum of 8 years in Pharmeceutical, Healthcare or related industries

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. • 2-3 years' experience leading multiple aspects of a global clinical trial
• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
• Experience of 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, communication and presentation skills are required.
• Travel up to 15-20% of the time, defined by business needs.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check

Required Skills:

Preferred Skills: