Associate Director, Clinical Supplies Project Manager

The RoleAssociate Director, Clinical Supplies Project Management is responsible for oversight and leadership of clinical supply activities for a program and/or a clinical study.  The scope includes the operational planning and strategy required to execute end-to-end supply management, including demand planning, label development, packaging/labeling, distribution, IRT UAT/supply management, temperature excursions, and site activations. This position works collaboratively across several therapeutic area teams and cross functionally to support study needs.  May be an individual contributor or lead a team of direct reports, including Clinical Supply Project Managers or Specialists.  The role requires skill at understanding the needs of critical programs with attention to detail, with a collaborative outlook, and with the ability to manage workload and meet project timelines.Here’s What You’ll DoAssists in identifying resources required to manage programs and their associated clinical studies. Provides leadership to more junior colleagues by supporting their development through coaching and identifying key opportunities for development.Accountable for planning, strategies and budget management for programsDrives best practice for supply logistics and for the processes surrounding clinical suppliesOversee process for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical suppliesResponsible for logistics as required to support the labeling, packaging and shipment of clinical drug supplies to depots/investigative sites as well as other clinical supplies as necessaryMay contribute to business review meetings with third party drug supply vendorsWith Clinical Study Team inputs and IRT PM, responsible to contribute to the development of IRT requirements, user acceptance testing, and supply management after IRT go-live.Responsible for Clinical Supplies Planning and Forecasting as required to meet program objectivesDevelop and compile KPI (metrics)Primary interface with CMC for Production Planning & Distribution; develops best practice for forecast of all drug supply needsManages work with Clinical Packaging Organizations, IRT vendors, and CROsDrives the creation/develop of processes that drive best practice for clinical supplies.  Implements industry best practices for clinical drug supply activitiesCollaborates with CMC, clinical, and project management on production schedules so timing of clinical trial drug needs are metMaintains collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirementsResponsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical, regulatory departments; and coordinating the work schedule of clinical supplies project managersOversee vendor activities including procurement, labeling performance, on-time delivery, quality, improvement initiatives and issue resolutionDevelop pharmacy manuals in conjunction with relevant cross functional leadsDevelop drug and clinical supply training materials for investigational sitesHere’s What You’ll Need (Basic Qualifications)At least 8 years of clinical supply management experience in a clinical research environmentBachelor’s degree in a science-based subject (advanced degree preferred)Prior Cold Chain distribution experience requiredIRT implementation, design, and management experience requiredPrior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferredCreative, capable problem-solverExperience in establishing and maintaining relationships with vendors and attending business review meetings (Vendor oversight)Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirementsDemonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomesPay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needsA holistic approach to well-being, with access to fitness, mindfulness, and mental health supportFamily planning benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investment opportunities to help you plan for the futureLocation-specific perks and extrasThe salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a pla