Associate Director, Clinical Supply Integrator
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Beerse • Belgium
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Job Level
Tech Stack
About the role
- Serving as the CSC project and team leader for assigned compounds
- Driving global teams to define and manage change, challenge the status quo, and implement solutions
- Providing mentorship and guidance to team members
- Leading the monthly Clinical Supply & Operations Planning (cS&OP) cycle for each compound
- Developing and maintaining an integrated demand and supply plan from API to clinical kits
- Handling partner concerns and resolution of critical risks and issues with minimal supervision
- Representing CSC on Chemistry, Manufacturing and Controls (CMC) and Clinical teams (CT), ensuring alignment with product strategy
- Communicating and implementing strategy and development plans with high autonomy and accountability
- Building strong collaborations with Therapeutic Areas (TAs), Global Development (GD), and Therapeutics Development & Supply (TDS)
- Acting as Single Point of Contact (SPOC) for TAs and GD as needed, supporting due diligence, partnerships, and early access programs
- Ensuring uninterrupted clinical supply through effective planning, budgeting, and coordination
- Influencing trial design and operational aspects to optimize cost efficiency and customer experience
- Managing compound activities to meet key CSC/CMC/CT deliverables, including long-range demand forecasting, formulation selection, and comparator sourcing
- Participating in Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) health authority inspections
- Contributing to functional strategy development and process improvements (quality, cost, time, asset utilization)
- Supporting recruitment strategy, team structure, and promotional decisions as needed
Requirements
- A minimum of a Bachelor's degree is required
- 8+ years of relevant experience is required
- Strong knowledge of GCP/GMP regulations and clinical trial operations is required
- Ability to manage complex projects with accelerated timelines is required
- Problem Solving/Decision Making - Creates a culture that empowers others in the analysis of strategic issues; independently identifies and manages the impact across the business with no supervision required
- Project Management - Leads multi-dimensional projects across the business; manages the inter-relationships among projects to drive optimal outcomes, processes, and people
- CMC Drug Product Development - Demonstrates in-depth knowledge of end-to-end (E2E) CSC activities and the broader development process/organization to support the G&O development with impact on departmental strategy
- E2E CSC Accountability - Accountable for portfolio projects across CMC and clinical teams'; manages internal and external partners; understands and helps shape strategic objectives and translates them into day-to-day execution
- Matrix Team Leadership – Leads the CSC sub-team applying innovative approaches and out of the box thinking; provides coaching to help develop the team members
- Quality – Ensures project activities which is safe, effective and otherwise aligned with global health authority expectations
- Communication - Develops forums, systems, and processes that result in information sharing internally and externally; confidently presents controversial and/or complex information to all levels of the organization
- Critical Thinking - Understands and shapes strategic objectives of the TDS organization and implements these strategies in daily activities;; helps others understand and apply organizational objectives
- Cross-Functional Coordination - Viewed as a trusted partner across the business and with internal/external therapeutic area experts; anticipates relationship needs, proactively builds alliances, and leverages partnerships strategically
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GCPGMPproject managementclinical trial operationsCMC drug product developmentdemand forecastingformulation selectioncomparator sourcingprocess improvementsbudgeting
Soft Skills
problem solvingdecision makingmatrix team leadershipcommunicationcritical thinkingcross-functional coordinationmentorshipcollaborationinfluencingautonomy
Certifications
Bachelor's degree