Associate Director, Temperature Strategy
5 days ago
Johnson & Johnson Innovative Medicine Research & Development (JJIM R&D) is seeking an Associate Director, Temperature Strategy & Execution to join our Clinical Supply Chain (CSC) team.
About the Role:The Associate Director, Temperature Strategy & Execution will be responsible for leading a team and setting the strategic direction for temperature-related matters in the worldwide distribution of clinical supplies. This includes developing and implementing new solutions, improving existing processes, and ensuring compliance with GxP guidelines.
Key Responsibilities:- Lead the Temperature Strategy & Execution (TS&E) team and model conscious inclusion and J&J Leadership Characteristics.
- Develop and recruit diverse talents.
- Accountable for TS&E processes, including Audits & Inspections, Temperature Excursion Assessment, and Temperature-related base business escalations.
- Oversee TS&E governance within Clinical Supply Chain (CSC) and within partner organizations.
- Ensure TS&E activities are consistent with all Standard Operating Procedures (SOP) and GxP, Quality, and Regulatory guidelines.
- Develop and lead future-state strategy for TS&E focused on enhanced processes, governance, and technology.
- Own requirements on how Clinical Supplies should be monitored and controlled during transit to and storage at Investigational Sites and Depots.
- Accountable for passive shipper and temperature monitoring device strategy in CSC, including requirements, performance standards, evolution, and day-to-day oversight.
- Conduct TS&E as a center of excellence, addressing temperature management requirements for storage and transit of study drug.
- Develop strong internal collaboration with and influence functional and cross-functional stakeholders to ensure base business execution and anticipate upcoming needs and drive synergies when developing new capabilities.
- Support changes to the portfolio including new trials, strategies, modalities, licensing & acquisitions, and business integrations.
- Proactively apply data and metrics to drive continuous improvement and sponsor continuous improvement initiatives across the end-to-end logistics' team.
- A minimum of a Bachelor's degree is required with a focus in engineering, business, supply chain, or technical sciences.
- A Master's degree as well as other certifications including APICS, Project Management (PMP, FPX), Six Sigma, or Lean are preferred.
- A minimum of 8 years of relevant professional experience in pharma/life sciences.
- Experience with minimum one of the following functions: clinical operations, logistics, distribution, operations, temperature management, temperature monitoring devices, quality assurance, supply chain planning, and/or analytical development.
- Demonstrated people leadership and talent development experience.
- Experience in defining a vision, strategy, and driving its execution.
- Demonstrated ability to improve processes end-to-end.
- Ability to work in a fast-paced global environment both independently and collaboratively at various levels across the organization and with external service providers.
- Strong interpersonal skills and demonstrated ability for strong collaboration.
- Ability to work in a highly regulated environment.
- Knowledge of Clinical Supply Distribution, Clinical Study Execution, and GxP principles.
- Solid understanding of ambient, cold, frozen, and/or deep frozen (cryo) distribution requirements.
- Experience with clinical supply management tools preferred.
- Experience with quality system tools preferred.
- Intermediate to advanced software skills preferred (e.g., Microsoft Excel, PowerPoint).
The anticipated compensation for this role is $135,000-$232,300. Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
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