Lead, Clinical Supply Chain
The Lead, Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical programs. Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. Represents Clinical Supply Chain to internal stakeholders and manages relationships with external supply partners. Has a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment. Works with management to develop and implement process improvements to build the organization for the future.
- Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC).
- Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines.
- Create supply and inventory plans and develop production schedules for clinical trial materials.
- Monitor schedule adherence of production schedules and make course corrections if needed.
- Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability.
- Manage the relationship and oversee daily activities for FG label & pack CMOs and distribution vendors.
- Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure.
- Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s).
- Coordinate review and approval of labels with stakeholders (e.g. Regulatory, Clinical Operations, CRO) and CMOs.
- Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system.
- Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses.
- Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans.
- Lead cross functional projects and process improvements related to drug supply.
- Assist in the creation of Standard Operating Procedures.
Partner with senior leadership and staff in Technical Operations to drive effective engagement, planning, decision making, and value thinking.
Lead financial planning and analysis for commercial drug substance, drug product, and finished goods manufacturing, and product distribution
Member of the Launch Readiness Team - Drive pre-commercial planning and setup of order-to-cash processes and systems to support successful product launch
Collaborate directly with Third Party Logistics provider (3PL) partner to create and manage the following processes: accounts payable, invoicing, reconciliation, month/quarter/year end closing accounting, and chargeback
Lead financial planning and analysis for R&D drug substance and drug product to support advancement of clinical and discovery programs
Partner with others in Finance & Accounting to ensure effective utilization of systems, application of excel models/tools, reporting and information sharing
Support broader organization through ad hoc projects and analysis
- Bachelor's degree and 5+ years of experience
- 3PL & Cost Accounting experience required
- Demonstrated strong collaborative and leadership skills and effective in working with cross-functional team members
- Excellent written and oral communication skills and ability to develop and present analyses to senior members of supply chain, tech ops, finance, accounting, and tax
- Ability to work external customers including CMOs, materials providers, and external auditors
- Experience in developing standard cost analysis to aid in contract negotiations with suppliers of materials, capital equipment, and services.
- Experience developing robust analyses in support of inventory reserves, including the identification of required reserves and the monitoring of reserves
- Experience with import/export duties and taxes associated with pharmaceutical products
- Related industry experience with commercial and research and development programs
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.