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Clinical Supply Logistics Lead
3 months ago
"We are focused on results. Those that can be measured. And those measured in ways beyond numbers. We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcomes. Our innovation means trying new things, learning from our mistakes, and consistently refining our approach. Our strategies help us define our path to success, but our effectiveness is based in the aggregate power of our initiatives to impact holistic change."
-Bill Gates and Melinda French-Gates
The Bill & Melinda Gates Medical Research Institute (Gates MRI) is a non-profit biopharmaceutical development organization primarily dedicated to the development of impactful biopharmaceutical interventions for diseases that disproportionately affect the world's poorest populations, diseases that combined cause five deaths every minute. Headquartered in Cambridge MA, the Institute is designed to advance novel drug, biologics, and vaccine candidates through late-stage development and registration. The Institute encompasses experienced biopharmaceutical development professionals across regulatory, CMC, and clinical functions as well as comprehensive operational support functions. The Institute's programs are managed by its internal teams and functional areas in collaboration, working with partners across the global health ecosystem.
The Institute is based on five core "mantras" that are embedded within the organization and its people:
- Urgency: Execute with excellence to maximize impact.
- Collaboration: Establish empowered teams to drive our bottom line: lives saved.
- Innovation: Build on the known, uncover the new, achieve the unprecedented.
- Rigor: Drive the science, focus on the details, and execute with the highest quality.
- Courage: Dare to confront the world's most significant global health challenges.
As a wholly owned subsidiary and separate legal entity of the Bill & Melinda Gates Foundation, the Institute partners scientifically, operationally, and financially with the foundation to leverage the foundation's ongoing support and contributions toward the achievement of global health equity.
The Institute is currently composed of 160 employees and leverages dedicated vendor partnerships and consultant staff to assure the right skills are in place at the right time while retaining the flexibility to adapt as required by the development program portfolio.
The Gates MRI offers hybrid work arrangements, a 50% mix of on-site and work-from-home, and a competitive relocation package for those looking to move to the Cambridge, MA area. Remote employment is not offered for this role at this time.
THE POSITION
Reporting to the Head of Clinical Supply, the Clinical Supply Logistics Lead will be responsible for overseeing the planning, transfer, and distribution of research products and clinical supplies used in Gates Medical Research Institute clinical studies.
- Work with Chemistry Manufacturing & Controls (CMC) and Clinical Supply (CS) team to manage the movement of Investigational Product (IP) and other finished goods between vendors, depots, and clinical sites.
- Work with Inventory Manager to oversee movement of raw materials, excipients, API, Drug Substance (DS), Drug Product (DP), ancillaries, GMP & non-GMP material, and other products between vendors, partners, depots, and storage locations.
- Work with internal and external partners to develop & maintain shipping playbook(s) or database(s) for shipping lanes between vendors and between distribution depots and clinical site countries, including requirements and timelines related to import licenses, importation, and shipment documentation.
- Develop and maintain appropriate templates and planning tools associated with country requirements.
- Develop and maintain procedures/work instructions related to distribution planning activities.
- Serve as a distribution and logistics Subject Matter Expert for the Clinical Supply team, covering topics such as valuation development HTS code assignment, Import for Export set up.
- Train and coach team members on all areas of distribution and logistics referenced in this role.
- Serve as the point of escalation and support for clinical supply matters related to import/export challenges.
- Work with Strategic Sourcing and Procurement (SS&P) and Quality Assurance (QA) to establish active depot networks.
- Work with CS, CMC, QA and Clinical Operations to assess and resolve shipment related quality events.
- Work with SS&P to ensure appropriate logistics service providers (e.g. couriers, brokers) are in place.
- Lead strategic import/export initiatives and process improvements.
- Triage, resolve, communicate and escalate distribution issues that may impact the timeliness or quality of the supply chain materials.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree, Master's degree preferred.
- Minimum of 10 years related experience in pharmaceutical or clinical material movement.
- Experience managing logistics for studies in challenging geographies including Africa, Southeast Asia, and Latin America preferred.
- Experience managing temperature-controlled material in extreme climates.
- Experience developing and maintaining shipping lane information, processes and documentation.
- Experience of managing strategic relationships associated with distribution and logistics.
- Excellent communication skills.
In recognition of high-wage market differences such as the Cambridge, MA area where this position is located, the salary range for this role is $TBD-$TBD USD. As a mission-driven organization, we strive to balance competitive pay with our mission. New hires salaries are typically between the range minimum and the salary range midpoint. Actual placement in the range will depend on a candidate's job-related skills, experience, and expertise, as evaluated during the interview process.
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Hiring Requirements
As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.
Candidate Accommodations
If you require assistance due to a disability in the application or recruitment process, please submit a request here.
Inclusion Statement
We are dedicated to the belief that all lives have equal value. We're committed to creating a workplace where employees thrive both personally and professionally. We also believe our employees should reflect the rich diversity of the global populations we aim to serve-in race, gender, age, cultures and beliefs-and we support this diversity through all of our employment practices.
All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.
