Associate Director, Clinical Drug Supply & Logistics
Location: Tarrytown New York United States
Summary: The Associate Director Clinical Drug Supply and Logistics is responsible for driving operational activities related to Investigational Product used in the conduct of clinical research projects in order to ensure deliverables and program objectives. Collaborates with IOPS manufacturing teams and Clinical Program and Study teams on forecasting and supply distribution aspects of the study(ies) or program(s). The AD interacts at a visible level with internal senior level management, external vendors, collaboration partners and clinical study and IOPS personnel to ensure compliance with business practices, and clinical research project objectives. The AD effectively mitigates risk across studies and programs. The AD may be responsible for managing clinical logistics drug supply staff.
Responsibilities: Operational Activities • Performs job duties with minimal guidance; Identifies program risks; proactively creates and implements mitigation strategies; Leverages operational expertise and communicates operational needs effectively to ensure goals are met; Drives decision-making and integrates operational facets for studies and/or programs to ensure goals are attainable prior to implementation.; Develops work plans, establishes clinical supply objectives, assigns tasks appropriately (aligns skill sets with assignments); Maintains schedules (timelines) for overseeing assigned clinical research studies and drives decision making to ensure adherence to timelines; Provides guidance to Clinical Logistics Team through setting goals aligned with department goals; Identifies and recommends changes to practices and policies; Resource Management • Directs activities of resources, internal, external and vendors; Recommends additional resources based on needs to meet goals and milestones; Acts as a point of escalation for internal and external team members; Plays a key role in outsourcing plans for clinical programs and ensures outsourced services are provided according to the study needs and within the budget; Communications • Interfaces with senior management to report on project and program milestones and to present project needs; Communicates operational aspects related to IP in each project throughout the organization; Contributes to clinical development planning and life cycle timelines; Acts as the point person for IP information on different projects in program; Attends appropriate development and management meetings; Provides timely and accurate information to Department Management and Clinical Trial Management for program level tracking; Supervising • Leads, guides and mentors Clinical Logistics staff. Assignments are given in the form of objectives with little or no process defined; Develops and provides challenging yet appropriate assignments and communicates progress toward development goals. Experience and Required Skills: Requirements: Bachelor’s degree and at least 10 years of relevant experience in the biotechnology/pharmaceutical industry, with 5 years minimum in clinical supply management. At least 3 years line management experience, if applicable.
Strong leadership skills; Must be able to effectively communicate to all levels of the organization, including senior management; Analytical problem solving experience; Must be able to develop and present varied and unique ideas; Effective influence and negotiation skills; Proven Management skills; Financial acumen in creating and managing clinical supply budgets; Ability to build successful collaborations with internal and external partners; Must possess strong communication skills; verbal, written, and presentation; Must have broad knowledge and cross-functional understanding of clinical trial methodology; Working knowledge of GCP and ICH.
Success factors: Integrity and Trust Negotiating Developing Direct Reports and Others Process Management Delegation Innovation Management Managerial Courage