Senior Manager, Trial Delivery Leader (Immunology)

Johnson & Johnson•Ambler, PA

1d•$137,000 - $235,000•Remote

About The Position

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 https://www.jnj.com Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, 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 a Senior Manager, Trial Delivery Leader (Immunology). This is a remote role available in Spring House, PA; Titusville, NJ; or Raritan, NJ. Remote work options may be considered on a case-by-case basis and if approved by the Company. Please note that this role is also 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 postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Beerse, Belgium; Leiden, Netherlands; Warsaw, Poland - Requisition Number: R-052528 High Wycombe, UK - Requisition Number: R-052531 Allschwil, Switzerland - Requisition Number: R-052532 United States - Requisition Number: R-050341 Remember, whether you apply to one or all requisition numbers, your applications will be considered as a single submission. Purpose: The Senior Manager, Trial Delivery Leader (TDL) in Immunology is accountable for end-to-end clinical trial delivery, providing operational oversight of cross-functional deliverables for the Late Development or Early Development portfolio. 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 according to guidelines.

Requirements

Minimum of bachelor’s degree is required
Preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 8 years in Pharmaceutical, Healthcare or related industries.
2-3 years’ experience leading multiple aspects of a global clinical trial.
Experience in and knowledge of the pharmaceutical development process.
Clinical research operational knowledge and experience across multiple phases of studies; must have the ability to lead all aspects of execution of a clinical trial.
Must possess excellent leadership skills and proven track record to cultivate 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.
Strong project planning/management, communication and presentation skills
Travel up to 15% of the time, defined by business needs.

Nice To Haves

Immunology experience
Experience in early development clinical trials

Responsibilities

Responsible for leading the Cross Functional Trial Team (CFTT) to develop the trial level operational plan and for end-to-end trial coordination.
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).
Identifying 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.
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.
Mentor & support onboarding of new team members, particularly those in Trial Management.

Benefits

Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year