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
Remote work options may be considered on a case-by-case basis and if approved by the Company.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for a
Program Delivery Manager - IP Admin.
The
Program Delivery Manager - IP Admin is responsible for the oversight, training strategy/delivery of Investigational Product (IP) across relevant GCO roles and sites. Activities include development of the strategy for engaging with investigational sites as it relates to IP and serving as the internal primary point of contact for GCO. Deliver strategic insights and constructive feedback to refine IP study-related documentation, drive protocol training initiatives, and oversee the resolution of IP-related issues at the site level.
Key Responsibilities:- Portfolio oversight within the assigned therapeutic area to ensure alignment and consistency across the portfolio.
- Support the development of high-quality training solutions leveraging a variety of techniques for knowledge transfer; this may include other protocol-related topics.
- Provide consultation as a Subject Matter Expert through the training strategy process to produce high-quality educational materials.
- Facilitate training needs assessments, as applicable, with various teams to define plans with clear learning objectives.
- Lead internal and sponsor training, providing intensive support depending on IP complexity. Act as the main point of contact for the resolution of any questions associated with IP.
- Demonstrate a strong presence and authority by leading discussions and ensuring the training strategy meets all quality, regulatory, and operational expectations.
- Exhibit effective leadership skills, including the ability to develop and implement strategies and to foster team productivity and cohesiveness.
- Support pharmacy/Investigational Product (IP)-related inspection readiness activities and provide input and follow up on audit CAPAs.
- Monitor key IP risk indicators, and escalate and mitigate issues as required.
- Demonstrate excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
- Communicate persuasively with relevant internal stakeholders. Confidently advocate for best practices, ensuring all stakeholders adhere to high-quality standards. Take decisive action to resolve inconsistencies, challenge unclear guidance, and escalate concerns when necessary.
Principal Relationships:The Program Delivery Manager-IP works closely with:
- CTL&T team members
- GCO business partners
- R&D Quality
- Global GCO Compliance
- Delivery Units
- Other groups responsible for authoring the IP instructions
Contacts Outside of the Organization:- Training Vendors
- External Subject Matter Experts
- External Industry Groups
Education Requirement:- Bachelor's degree in nursing, with an active license (if applicable). Advanced degree in a scientific discipline and/or master's degree are preferred.
Related Experience: - A minimum of 5 years of clinical research experience acquired in the pharmaceutical industry, CRO, or an investigational site is required. Early development/first-in-human clinical trial experience is required.
- Immunology experience is preferred.
- Strong knowledge of drug development, clinical research operations, and regulatory requirements, including ICH-GCP, GMP, and applicable regulations, is required.
- Familiarity with global site practices is required.
- Experience with training needs assessment, development, and facilitation of training programs with clear learning objectives is required.
- Experience in the preparation of novel pharmaceutical therapies.
- Experience in a leadership role, demonstrating the ability to develop and implement strategies and to foster team productivity and cohesiveness.
Other:- Proficiency with Microsoft Office tools (e.g., Excel, PowerPoint, One Note), Office 365 and SharePoint (or other similar collaboration tools), and graphical tools that enables you to organize complex ideas visually.
- Fluency in English required.
- Travel Percentage: 10-30%
#LI-Remote
Required Skills: Preferred Skills:Analytical Reasoning, Budgeting, Clinical Trial Management Systems (CTMS), Clinical Trials, Compliance Management, Contract Management, Execution Focus, Fact-Based Decision Making, Laboratory Operations, Mentorship, Process Improvements, Project Integration Management, Research and Development, Research Ethics, Standard Operating Procedure (SOP), Technical Credibility
