Executive Director, Clinical Trial Supply and Logistics
United States - RemoteUnited States of America, Remote Job ID R0000031435 Category Clinical Logistics
About this Role
The Executive Director, Clinical Trial Supplies and Logistics, Worldwide Production, Labeling & Depot (PLD) is a senior business professional who provides global leadership, clinical trial supply solutions and strategies, directs all global Operational PLD aspects of the Clinical Trial Supply Management, including execution of Clinical Trial Supply Packaging, Labeling and Distribution “(PLD”), ensuring that projects are conducted in compliance with client and regulatory requirements, client relationship management, commercial growth of the overall business unit and financial accountability ensuring cost effective and profitable projects.
Key Accountabilities:
Team Leadership
- Meet and aim to exceed client expectations by recruiting, retaining and developing a skilled, experienced and motivated team.
- Lead the performance, development and growth of Global PLD team.
- Work with the global management team within PLD worldwide to ensure consistent work practices, mentorship and support to enable team members to deliver key objectives and to ensure team members grow and develop essential skills to progress.
- Line management of assigned team
Business/ Operational Leadership
- Drive business and projects growth; increasing NBA, revenues and profits.
- Oversees profit and loss of global PLD – Supply Chain Services.
- Act as executive oversight of selected large projects and its supply chain where applicable.
- Identify, drive and implement operational excellence process improvements, including Clinical Trial Packaging initiatives (i.e., JIT) in conjunction with the Management team and Trainers, in response to client and team feedback and quality audits.
- Implement lean management approach and process improvements, in conjunction with the Management team, in response to corporate, quality, client and team feedback and quality audits.
- Oversee the development Packaging Labeling and Distribution (“PLD”) expertise, including Packaging, Distribution and Returns Protocols
- Establish, monitor and report KPI/metrics
- Construct and manage departmental annual budget and monthly resource and -forecast processes
- Plans strategically to anticipate and meet all customer requirements.
- Ensure cGxP readiness and compliance with operation (cGMP, SOPs, etc.) and adherence to practices for all employees.
- Drive Value proposition integrated PI service offerings; CTS&L included in CRS Bids; Concrete sales standalone approach; pricing tools improvement; tailored marketing around integrated service offerings
- Contribute as needed Solutions & Business lead with Strategic Account leaders CRS,
- Align with Global Head Clinical Trial Supply on optimal CTS operations to ensure high quality, regulatory compliant, on time packaging, labeling, warehousing, and distribution of clinical supplies for Phase I through IV clinical protocols conducted globally and or locally.
- Works closely with colleagues from other CTS&L departments and sites worldwide to ensure that work practices and interfaces with global customers are optimized.
- Participate in and contribute to project/program bids, including client presentations.
Quality Control/Quality Management/Technical Support
- Leadership and direct alignment with Quality of required elements of cGxP across CTS&L.
- Develop management team expertise in PLD processes and execution
- Strategic improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, client feedback, audit results and QC measures.
- Provide technical support to management team members to ensure that they have the required knowledge to fulfill their duties.
- Ensure quality management in conjunction with QMs of PLD and technical processes and Central File documentation taking appropriate remedial action.
- Advice or request training from QMs of individual and departmental training needs.
- Organize in cooperation with QMs technical trainings by assigned technical trainers of functional groups.
- Recognize individual and departmental training needs, request training from QMs as needs are identified.
- Revise, approve, implement and monitor departmental compliance with SOPs.
- Manage Quality Incidents, ensure Root Cause Analysis, related Corrective and preventive action (CAPA, also called Corrective Action / Preventive Action, or simply Corrective Action) acceptable and actioned.
Financial Oversight
- Provide accurate planning & resource projections, proposing global workload balancing as necessary
Skills/Competencies:
- Strategic Planning development
- Merger and Acquisition understanding and execution
- Strong leadership presence in regional department and in front of clients, industry experts and executives.
- Outstanding written and verbal communication skills across multiple Global regions and cultures, including experience with making presentations at conferences, meetings and in front of clients.
- Ability to provide leadership to global management team, work in matrix environment, identify and nurture key talent, motivate and integrate teams
- Self-motivated and able to work both independently and collaboratively in a dynamic and fluid business environment.
- Support and provide input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, and cGxP.
- Define and develop governance standards specifically for conducting clinical trials including; Project Planning/Tracking; Status Reporting; Issues Management/Escalation/Resolution; Risk Management; Vendor Management; Financial Management and Resource Management.
- Conduct due diligence and evaluation of new service lines for development.
- Support client acquisition initiative to significant change in Market segment
- Ability to design, present and implement specific plans to ensure high quality products and services and to ensure that all tasks maintain defined timelines to meet the goals of the study
- Strong financial management (growing or maintaining margins) and line management experience.
- Study and Operational Planning, ability to schedule and ensure project execution skills required
- Subject Matter Expert in Global Clinical Trial Supplies PLD
- Directs processes for forecasting, scheduling and executing the activities supporting CTS.
- Knowledge and or leader of all aspects of the PLD of Clinical Trial Supplies (CTS), including Project Management.
- Responsible for assuring compliance to regulations and procedures regarding the handling, packaging, labeling and distribution of clinical material according to company as well as cGMP regulation as defined by the FDA and international regulatory agencies.
- Ability and experience in evaluating CTS technologies, to determine their impact on the operation, and facilitates their implementation.
- Must possess strong problem-solving skills using creative and innovative thought.
- Proven consultative commercial selling and negotiation, communication and customer management skills
- Willingness and ability to travel
- Ability to think strategically in regard to the development of the department and cross- departmental relations
- Affinity, willingness and ability to initiate and complete business development tasks, such as strategic development of project proposal generation & presentation
- Demonstrable experience of stakeholder/relationship management with a client focused approach to work. Strong ability to understand the business implications of decisions and impact on client.
- Strong analytical skills and ability to identify and address issues proactively in a timely manner
- Affinity, willingness and ability to understand and conduct financial tasks such as budgeting, cost control and negotiations
- Ability to strategically develop department and cross-departmental relations work effectively in a matrix environment.
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Very good knowledge of Microsoft office programs
- Optional: Training skills for operational processes and/or systems
Knowledge and Experience:
- Minimum of 20 + years clinical trial supplies project management, packaging, labeling and distribution, and/or manufacturing investigational product working for a CMO or Pharmaceutical Company.
- Of which 15 + years leadership experience direct in clinical trial supplies clinical supplies organizations Strategic planning development and execution
- Developed strategic alliances, pricing models, and client relationships
- Developed and implemented Key Performance Indicators metrics and Balanced Scorecards
- Established Global Quality Management systems
- Led Operational Excellence programs
- Developed Clinical Supply Project Management and xSBU teams within CMO and or Pharmaceutical Company.
- Development and implementation of global Clinical Supply Operations PLD processes direct experience with clinical supplies operations including:
- Packaging Labeling Distribution planning, design and storage
- Study and Operational Planning
- Identifying, hiring and maintaining staff
- Track record in successfully leading teams in a high growth volume global Clinical Trial Supply service environment
- Prior P&L responsibility, and budget management
- Building retaining client relationship in the biopharmaceutical industry Involvement in change management
Education:
- Bachelor’s degree, in Finance, Pharmaceutical Sciences, Engineering, Logistics or scientific discipline or business administration. MBA or Professional designation preferred
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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