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Associate Director
4 months ago
About the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a difference?
The Position
The Assoc Director OED - Supplies, is responsible for US and CA supply operations including country oversight of Planning, Purchasing, Logistics and Customer Service with the function to improve the core processes that result in improved supply availability, reduced inventory turns, and lower cost. The role will ensure that performance metrics are met by focusing on demand planning, supply planning, and distribution requirements planning and Trial deliverables across NACD. This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that will translate into capacity and inventory strategies to decrease costs and create efficiencies. Manage end to end supply, order management, placement and delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution and spend of ancillary supplies for NACD.
Ensure business needs are met through alignment of business plans and operational need within the Therapy Area and OED to regarding continuous efficiencies and optimization of organization resource allocation. Responsible for managing internal and external strategic collaborations to optimize Operational Excellence and Delivery (OED) performance by building relationships, developing and maintaining strong communication channels. Leads successful investigator and strategic partnership negotiations in accordance with all relevant regulations and policies; (Good Clinical Practice (GCP), ICH guidelines, federal regulations (Sunshine/Open Payments Act), and within defined budgeting guidance).
Relationships
Reports to the Executive Director OED. Accountable for managing relationships with external partners relevant to the planning and execution of CMR initiatives; actively participating in multiple internal cross-functional teams to ensure the effective delivery of all functional and departmental milestones.
Establish and manage relationships with external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACD & Novo Nordisk (e.g. Investigators and site staff, vendors etc.). Establish and manage senior level relationships positively with multiple internal stakeholders relevant to the design & implementation of clinical trials improvement/innovation projects for NACD & Novo Nordisk (e.g., across NACD, CMR, International Operations (IO), HQ CDD, & Commercial). Supervisory responsibilities including both direct and indirect reports, as well as supporting contingent workers.
Essential Functions
Planning and strategy:Develops and drives goal setting, prioritization, and operational implementation plan for supplies in partnership with NACD and protocol timelines; considers relevant input and guidance to other areas within NACD including Operations Director and TA HeadsEnd to End Supply Operations across TasRemove bottlenecks and accelerate the expansion of operational capacity for suppliesPeople management:Provides daily people management individual contributors to ensure effective performance management, team collaboration, training and development, employee engagement, and recognitionChange management:Identifying areas for improvement in operational processes, analyze portfolio internal processes and implementing changes to enhance efficiency, productivity, and quality. Encouraging a culture of continuous improvement, promoting innovation, and seeking ways to optimize operations through new technologies or practicesFinance & resource management:Track and forecast resource capacity in collaboration with NACD, utilization, and allocation to optimize productivity and ensure alignment with TA Head. Collaborate with OED, CMR Strategic Operations, and Finance to develop and ensure alignment managing resources such as personnel, equipment, and materials to ensure optimal utilization and allocation, and operational budgets, monitoring expenses, and implementing cost-saving measuresManage and negotiate contracts with critical North America vendors and depots to reduce costs and achieve maximum efficiencyThinks strategically and initiates strong and persuasive contractual arguments to support business policies and objectivesPerformance monitoring:Tracking key performance indicators (KPIs) to measure operational performance, identifying trends, and implementing corrective actions when necessary. Monitor and manage performance of external service providers, escalate issues where appropriate, and make the appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standardsRisk management:Assessing and mitigating risks associated with operations, implementing measures and staying current with regulations/practices/industry trends. Ensure staff is adequately trained in ICH, GCP, regulatory guidelines and internal processes/SOPsCross-ta collaboration:Responsible for implementation of best practices and standards for clinical operations, including sharing lessons learned. Partner closely with other departments and teams to coordinate operational activities, facilitate communication, and foster a collaborative work culture, including direct partnership with the Operations Director(s)Stakeholder management:Build strong internal and external relationships with key stakeholders across CMR, NNI, NNCI, and HQ-CDDMaintains a deep understanding of CMR strategy and industry trends to drive informed decision-making with management buy-in and timely action for optimal customer serviceEnd to End Supply Operations:Deep understanding of Distributor, Logistics and Demand Planning Operations (shipping, receiving, inventory control, customs clearance, supply / device management)Responsible to ensure timely availability of clinical study materials and ancillary supplies to North America distribution depots, and/or investigator sites across North America. This includes collaborating with customers and internal resources to define requirements, develop plans and timelines, and coordinating and executing project activitiesUnderstands high level import/export requirements for global distribution of clinical ancillary materials and ensures the appropriate distribution personnel are involved to provide guidance and detail import/export requirements, to generate required documentation and to ensure appropriate procedures are in placePoint of contact for Clinical Trial Call Center and coordinates with Patient Support ProgramsInfluences, leads, and effectively interfaces within a matrixed environment and with varying professional levelsLeads Clinical Ancillary Management project teams to ensure Clinical Ancillary Management services are defined and executed Physical Requirements 0-10% overnight travel required. Development of People Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way. QualificationsBachelor's degree required; science related discipline preferred. Advanced degree preferredA minimum of 10 years' progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting, with at least 5 of those most recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO)3 years supervisory experience or proven competency in coaching and training of staff/project team Experience in budget and contract negotiations with clear understanding/impact of contract and financial schedules, (i.e. cost benefit analysis, ROI, KPI, financial milestones and related payment schedules)Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP Principles and the application of those principles to trial design, planning & conduct of clinical trialsDeep understanding of Distributor, Logistics and Demand Planning Operations, Global Supply Chain, Cost Reduction and Supply Chain Trouble shooting/Problem Solving experience desiredAdvanced capability in MS Excel, MS PowerPoint and MS Word requiredExcellent and demonstrated negotiation skills with the ability to understand, identify, and explain contractual riskDemonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions and ability to apply related strategy to realityExcellent written and verbal communication skills and the ability to be clear and concise in a variety of communication settingsDemonstrated ability to collaborate with local and global stakeholders to design and execute analyses to support decision-making and planningExcellent skills in designing and implementing innovation/improvement initiatives, including the required change managementProject Management experience including demonstrated problem-solving skills, root cause analysis, financial return on investment analysis We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.