Lead, Trial Delivery Manager - Oncology

Johnson & Johnson•Titusville, PA

2d•Hybrid

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: Professional 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 About Oncology: 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. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. 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 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): United States - Requisition Number: R-052335 United Kingdom - Requisition Number: R-053621 Belgium, Netherlands, Poland, Spain, Portugal, Italy - Requisition Number: R-053618 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Remote work options may be considered on a case-by-case basis and if approved by the Company. We are searching for the best talent for Lead, Trial Delivery Manager, Oncology to be located in Lead, Trial Delivery Manager to be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Purpose: The Lead, Trial Delivery Management (TDM) is responsible for the execution of study-level activities, creating and updating trial-specific documents, vendor oversight & delivery, compound training, and other activities. The TDM is responsible for country and regional oversight of local operational delivery, including the alignment of the feasibility strategy and target setting, risk reviews and local challenges that could impact overall study delivery.

Requirements

BS degree or equivalent, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
Minimum of 4 years clinical trial experience in Pharmaceutical, Healthcare or related industries.
Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage multiple aspects of execution of a clinical trial.
2-3 years’ experience supporting multiple aspects of a global clinical trial.
Minimum of 2 years of oncology clinical trial experience.
Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
Experience 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, (e.g. organization, problem-solving, and adaptability) communication (e.g. effective communication with and managing expectations of stakeholders) and presentation skills are required.
Ability to think strategically and work through ambiguous situations.
Ability and experience to lead the Study Management Meetings.
Experience and skills utilizing technology (e.g. tools, systems with GenAI enabled capabilities) to obtain reports for efficient metric oversight.
Travel up to 15-20% of the time, defined by business needs.

Nice To Haves

CAR-T experience would be a plus

Responsibilities

Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).
Manage vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight.
Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries).
Support development of program-level compound training, collaborating with Clinical / CTL&T / Medical writing.
Provide input into trial level operational strategies.
Resolve trial-related issues and mitigate trial-related risks.
Participate in process improvement activities at a trial, compound & cross-DU level, as needed.
Provide support 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.

Benefits

Employees and/or eligible dependents may be 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.
Employees may be 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.
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year

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