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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical supply strategies, ensuring regulatory compliance, and optimizing drug distribution processes. Proven ability to lead cross-functional teams and develop demand forecasts while maintaining quality and cost-effectiveness.
Highest-signal resume keywords
Clinical Supply ManagementRegulatory ComplianceDemand ForecastingCross-Functional CollaborationInteractive Response Technology
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Drug Supply StrategyProject OversightSupply Chain PlanningRisk AssessmentCost AssessmentQuality ManagementInventory ManagementProtocol DesignProcess ImprovementCGMP Knowledge
Soft Skills
LeadershipProblem-SolvingCommunicationCollaborationStrategic Thinking
Tools & Technologies
Interactive Response TechnologySimulation ToolsAI-Enabled InsightsAutomation Tools
Industry Keywords
21 CFR Part 11Annex 13Investigational Medicinal ProductGxP AuditsClinical Trials
About the role
Key responsibilities & impact- Lead, represent, manage, and support the US Medical Affairs CSM team
- Develop drug supply strategy and tactical approaches for Sponsored, Investigator Initiated, Managed Access, and Research Collaboration trials
- Ensure complete project oversight and accountability for project deliverables
- Manage end-to-end supply strategy from high-level forecast to clinical sites
- Review planning assumptions in supply plans and forecasts
- Select appropriate supply models for packaging and distribution
- Ensure regulatory coverage and alignment with regulations and guidelines for FPFV readiness
- Manage Investigational Medicinal Product supply and bulk product inventory while maintaining quality and compliance
- Develop demand forecasts for long-term supply and capacity planning
- Provide clinical supply guidance in protocol design and clinical meetings
- Oversee execution of supply chain plans and resolve obstacles
- Solve complex issues to ensure patient supply without compromising quality, cost, or delivery
- Assess risks and define strategies for supply continuity and flexibility
- Lead cost assessments for labeling, packaging, distribution, and comparator activities
- Collaborate with Finance and Contracts teams on operational spend, third-party contracts, and cost controls
- Lead setup of Interactive Response Technology and Simulation Tool systems
- Use AI-enabled insights and automation to optimize clinical supply planning, execution, drug distribution, forecasting, inventory strategy, warehousing, depot-to-site distribution, risk detection, and decision-making
- Support vendor onboarding and GxP audits
- Lead externalization activities and manage CRO, vendor, supplier, distributor, depot, and IRT partnerships
- Establish working practices and SOPs and identify process improvements and standards across CSM
Requirements
What you’ll need- Bachelor’s degree is required with 10+ years of directly related working experience OR equivalent combination of education and work experience
- Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements
- Knowledge of drug development process
- Experience collaborating and working strategically with cross functional teams
- Up to 15% travel as defined by the business, domestic and/or international
- Local candidates only; relocation is not provided
- Knowledge of Interactive Response Technology and Simulation Tools set-up and management is preferred
Benefits
Comp & perks- Performance-based cash incentive
- Eligibility to be considered for annual equity awards, depending on role level
- Health benefits
- Life benefits
- Disability benefits
- 401(k) with company contribution and match
- Vacation
- Personal days
- Holidays
- Other leaves
- Reasonable accommodation for individuals with disabilities
