Associate Director, Clinical Drug Supply & Logistics - Operations
The Associate Director of Clinical Drug Supply & Logistics (CDSL) - Operations is responsible for driving the strategy, optimization and execution of business processes and analytic capabilities for the CDSL organization. This position plays a key role in translating planning excellence into operational outcomes, while using data driven insights, and driving a culture of continual improvement and responsiveness. Incumbent will be responsible for ensuring strategic alignment of operational and improvement activities in CDSL and external vendors while providing valuable analytical insights and business-critical reporting to meet the needs and support CDSL’s goals. The AD is also responsible for leading CDSL Operations staff.
- Manages distribution vendor oversight activities by acting as point of escalation for CDSL and supervises their performance against expectations and according to established policies and procedures.
- Leverage logistics performance metrics, identifies risks and implements remediation steps in partnership with our Vendors to ensure CDSL’s concerns are addressed.
- IP planning/management for clinical studies per business needs.
- Leads, guides, and mentors CDSL Associates Manager/ Associate in the execution of IP activities (i.e. release, shipment, temperature excursion management, returns, reconciliation, and destruction) and maintenance of TMF documentation to support clinical studies.
- Ensures CDSL is in a continual state of readiness with robust documentation workflow and archival.
- Manages and leads strategic and operational standardization, analytics and continuous improvement.
- Facilitates root cause analysis and appropriate continual improvement methodologies such as process mapping and kaizen events to achieve strategic imperatives set forth by CDSL
- Leads initiatives across the CDSL organization to identify data, process and system limitations.
- Liaises with IT regarding system current and future systems capabilities.
- Defines needs and develops data analytics and capabilities to enable data driven insights on the global clinical supply chain, collaborating with functional area partners, the broader GMP drug supply organization (Industrial Operations & Product Supply) and distribution vendors.
- In collaboration with Business Operations, create and run reporting metrics and determine how best to provide transparency to operational performance via report creation, insights and analyzing system dashboards.
- Develops reporting that drives continuous improvement against key performance indicators (KPIs). This will be accomplished by analyzing operational data to advise performance improvement opportunities with an emphasis on understanding key operational performance indicators and the impact they have on supply delivery.
- May require up to 25% travel
Bachelor’s degree (advanced degree preferred) and at least 10 years of relevant experience in the biotechnology/pharmaceutical industry, with 5 years line management experience.
- Strong Leadership Skills
- Ability to effectively communicate to all levels of the organization, including senior management
- Analytical, problem solving experience; Ability to develop and present varied and unique ideas
- Effective partner management, influence and negotiation skills
- Proven Functional and Line Management skills
- Financial acumen in creating and managing budgets
- Ability to build successful collaborations with internal and external partners
- Must possess strong interpersonal skills; verbal, written, and presentation
- Must have broad knowledge and cross-functional understanding of clinical trial methodology. Working knowledge of GCP and ICH