Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as a Director / Senior Director, Kit Production?
Position Summary:
The Director / Senior Director, Kit Production is responsible for Operational Planning, Strategy, Quality and Delivery of Clinical Trial Kits for distribution within the US and Abroad. Partner closely with Inventory Management and Global Shipping & Logistics Teams to ensure Client and Business Needs are achieved for U.S Labs.
Essential functions of the job include but are not limited to:
- Advise Project Managers and Proposal Writers on suggested kit components for intended use
- Work with Proposals and Finance Teams to ensure costs for Kitting activities are within / at / above margin
- Plan, Coordinate and Oversee all Kitting Activities; including Staff required to manage on-going Clinical Trials; ensuring Deliverables are met On-time and Error-Free
- Design and Redesign (as needed) Kitting Procedures and associated paperwork for an effective, streamlined process with impeccable quality
- Provide ongoing Kit Forecasting both short and long term for all Projects
- Determine future Kit Build Schedules by creating Projections with Project Management team, Scientific Team, etc.
- Ensure all supplies are ordered appropriately based upon a specified timeframe of Kit Needs
- Work with Project Managers to track Kit Usage against Schedules of Events and ensure kits nearing expiration dates are replaced
- Maximize Utilization of kit components across multiple projects
- Track expiration dates for supplies and implement mitigation for contents near or at expiry and execute corrective action where applicable
- Work with IT to fully utilize BSI and any future tools for Kitting and entire Supply Chain Management
- Identify and implement systems and tools consistent with current Best Practices for the Pharma Industry (Domestic and International)
- Provide and Support Strategic Direction for Global Kit Production
- Actively Participate and Support Process Improvement Initiatives
- Track Actionable Kit Production Performance Metrics for Production, Efficiency, Quality, etc.
- Secure required Licenses, Permits for product shipping Requirements for Studies and with Couriers, as necessary
- Serve as a Point of Escalation to provide guidance to staff and/or directly resolve issues with Partners and Stakeholders
- Participate in Internal and External Calls to support each Project as necessary
- Lead or Ensure thorough Investigation and Documentation of any Non-Compliance involving Kit Production
- Ensure Courier compliance to Business Review Meetings and other interactions that fosters Continuous Improvement between Parties
- Manage Kit Production Team for Growth and Development
- Identify areas for improved Efficiency, Effectiveness, and Cost Savings
- Ensure Kit Production area is compliant to Standard Operating Procedures, Regulated Standards, Quality, and Safety
- Carry out other Duties/Project, as assigned
Qualifications:
Minimum Required:
- Bachelor’s degree in Life Sciences or related field
- 8 years’ experience in Operations Management
- 2-3 prior Supervisory Experience
Other Required:
- Experience managing a facility that supports medical research
- Strong verbal and written communication abilities
- Effective Decision-Making skills
- A strong team leader with excellent interpersonal skills
- Demonstrated experience mentoring and developing team members
- Able to travel both domestically and internationally including overnight stays
- Must have and maintain a safe driving record and provide proof of such on an annual basis.
- Must be able to read, write, speak fluently and comprehend the English language
Preferred:
- MBA
- PMP Certification
- Clinical Trial Kit Production experience, to include Management of Production Processes and Staff
- Experience working in a Medical/Clinical Laboratory
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
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