Associate Director Clinical Drug Supply 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 direct line management of CDSL Operations staff.

In this role, a typical day might include:

• Leading distribution vendor oversight activities by acting as point of escalation for CDSL; monitoring their performance against expectations and according to established policies and procedures.
• Using logistics performance metrics, identifying risks and implementing remediation steps in partnership with our Vendors to ensure CDSL's concerns are addressed.
• IP planning/management for clinical studies per business needs.
• Leading, guiding, and mentoring CDSL Associate Managers and/or Associates 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.
• Ensuring CDSL is in a continual state of readiness with robust documentation workflow and archival.
• Leading strategic and operational standardization, analytics and continuous improvement.
• Facilitating root cause analysis and appropriate continual improvement methodologies such as process mapping and kaizen events to achieve strategic imperatives set forth by CDSL
• Leading initiatives across the CDSL organization to identify data, process and system limitations. Liaises with IT regarding system current and future systems capabilities.
• Defining needs and developing 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, building and managing reporting metrics; Determining how best to provide visibility to operational performance via report creation, insights and analyzing system dashboards.
• Developing reporting that drives continuous improvement against key performance indicators by analyzing operational data to advise performance improvement opportunities with an emphasis on understanding key indicators and the impact they have on supply delivery.
• Ability to travel up to 25%

This role may be for you if:
You can effectively communicate across all levels of an organization, including senior management
You are adept at developing and presenting multifaceted and unique ideas
You have solid financial acuity with experience creating and managing budgets
You have proven ability to build successful collaborations with internal and external partners;
You have broad knowledge and cross-functional understanding of clinical trial methodology;
You have working knowledge of GCP and ICH

To be considered, you'll need a Bachelor's degree and at least10 years of relevant experience in the biotechnology/pharmaceutical industry. A minimum of 5 years of direct line management experience is also necessary.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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