The AD of Clinical Drug Supply Operations will be responsible for driving the strategy, optimization and execution of operational business processes for the Clinical Drug Supply & Logistics department. This position will play a key role in translating planning excellence into operational outcomes, while leveraging data driven insights, and driving a culture of continual improvement and responsiveness. The incumbent will be responsible for ensuring strategic alignment of operational activity in the CDSL organization while providing value-added analytical insights and business-critical reporting to meet the needs, and support the goals, of the CDSL team.
Job duties and responsibilities:
- Manage and oversee Clinical Logistics Vendors in the strategic and operational execution of Clinical Supply Distribution. Includes monitoring performance, driving improvements, issue resolution, and escalation management.
- Manage and oversee strategic and operational Clinical Supply Operations activities, driving standardization, analytics, and continuous improvement.
- Lead a team providing support for Global Clinical Logistics planning & execution, ensuring compliant and timely shipment and delivery between depots and to investigator sites, working with our Logistics Providers.
- Ensure seamless regional execution through global Inventory visibility including management of material movements, expiry, returns, reconciliation & destruction processes, leveraging IRT and related systems and processes.
- Ensure appropriate visibility to priorities for optimization of QP release, Regulatory Release processes and CDSL support for Logistics Vendor and Industrial Operations activities (e.g. packaging campaign documentation), including co-ordination of expedited shipments.
- Define needs for data analytics capabilities to enable data driven insights on the worldwide clinical supply chain, collaborating with partner Clinical Drug Supply & Logistics Teams and the wider Regeneron Supply Organization (e.g. Industrial Operations).
- Develop reporting that drives continuous improvement against key performance measures both internally and with our logistics vendors. This will be accomplished by analyzing operational data to inform performance improvement opportunities with an emphasis on understanding key operational performance indicators and the impact they have on supply delivery.
- In collaboration with Business Operations, create and manage reporting metrics and determine how best to provide visibility to operations performance via report creation, insights and analyzing system dashboards
- Ensure team is in continual state of inspection readiness with robust documentation workflow and archival.
- Ensure appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
- Ensure integrity and accuracy of data within the CDSL team and flow through from our business partners.
- Lead processes to identify and define process improvement and simplification opportunities that enable more agile operations enhanced strategic insights and analytics.
- As a regional CDSL Lead the incumbent may coach junior staff co-located in region and act as escalation point for time dependent triaging of activities.
- Job duties may change at any time due to business needs.
Knowledge, skills and abilities required:
- Must be able to effectively communicate to all levels of the organization, including senior management.
- Experience working with and/or managing external vendors.
- Must be able to develop and present varied and unique ideas.
- Effective stakeholder management, influence and negotiation skills.
- Proven Functional and Line Management skills.
- Financial acumen in creating and managing budgets.
- Must have broad knowledge and cross-functional understanding of clinical trial methodology.
- Working knowledge of GCP and ICH.
To be considered for this opportunity, you should have a BSc and at least 10 years of relevant experience in the biotechnology/pharmaceutical industry, with 5 years line management experience.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.