Associate Director, Clinical Drug Supply Operations

Company: Moderna Therapeutics
Location: Somerville
Posted on: January 12, 2021

Job Description:

The Role:Moderna is seeking an Associate Director, Clinical Drug Supply Operations to manage the clinical drug supply needs across its clinical projects as well as to work with Clinical Packaging Organizations, IRT vendors and CROs. This position will work collaboratively across several therapeutic area teams as well as cross functionally to support study needs. This position will drive process and best practice for clinical supplies. The successful candidate will be skilled at understanding the needs of programs, with attention to detail, with a collaborative outlook, and with the ability to manage workload to meet project timelines. This position will have direct reports.Here---s What You---ll Do:Drive 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 necessaryManages business review meetings with third party drug supply vendorsResponsible for IRT requirements, user acceptance testing, and managementResponsible 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 CROsGenerates, reviews, and implements processes as required and ensures compliance to relevant SOPsImplements 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 requirementsMonitors and tracks shipments to ensure smooth transit through the logistical path ---including international shippingResponsible 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 Bring to the Table: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 outcomesHere---s What We---ll Bring to the Table: On-site subsidized cafeteria or catered lunchesCompany-provided iPhoneFree parking, monthly subway pass or a subsidized commuter rail passFree annual corporate membership to BluebikesHighly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSPFlexible Spending Accounts for medical expenses and dependent care expenses16 weeks of 100% paid parental leave for all new parents 16 weeks 100% paid family caregiver leave20 weeks 100% paid medical leaveEligible for ---Moderna Month--- (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)Adoption assistance and discounts to local childcare centers, as well as access to care.com401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediatelyA suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disabilityVoluntary legal assistance plan15 days--- vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)About Moderna:Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body---s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company---s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and BARDA. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit .Our Mission:Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.Moderna is a smoke-free, alcohol-free and drug-free work environment.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. LI-MM1- Full time

Keywords: Moderna Therapeutics, Somerville , Associate Director, Clinical Drug Supply Operations, Executive , Somerville, Massachusetts