Title/Position: Associate Director, Clinical Supply Management Reports to: VP, Clinical Operations Job Description: PMV Pharma is seeking a highly motivated AD, Clinical Supply Management is responsible for overseeing the end-to-end management of clinical supplies. The position involves strategic planning, coordination and execution of supply chain activities to ensure the timely and efficient delivery of clinical supplies. This includes all aspects of planning and oversight of vendors involved in the forecasting, design, production, and distribution of clinical supplies. The candidate will work closely with internal teams, external vendors, and stakeholders to support clinical trials and ensure compliance with regulatory standards. Responsibilities: CS Management Strategic Planning and Management Develop and implement clinical supply chain strategies including overall clinical supply plans, forecasts, packaging and labelling, and distribution strategiesLiaise with CMC on DP forecasting to ensure adequate long term bulk drug product availabilityOperational Execution and OversightManage and oversee activities, costs, and timelines related to packaging, labeling, distribution, and return or destruction of clinical supplies.Maintain plans, forecasts, and continuous inventory for PMV Investigational Product (IP), ensuring continuity of supply for all clinical studies conducted or supported by PMVProactively address the impact of regulatory and clinical updates during clinical trial conduct and adjust clinical supplies forecast and plans accordinglyContribute as an active core member in study teams such as the Clinical Trial Working Groups (CTWGs), to obtain and integrate trial information and country submission and approval timelines (including IND-IMPD amendments) to inform on clinical supply plans, activities, risks and issuesDevelop and manage clinical supply systems and tools (e.g. IXRS/RTSM) to assure proper supply module features, functionality, and usage Define clinical supply parameters in the RTSM system (as applicable) to optimize the distribution of material Monitor and manage clinical supply inventory levels to ensure continuous supply availability for patients/end users, and to prevent stockouts or overstocking Review and approve clinical supply documents such as packaging instructions and shipping documentsAuthor and/or review site-facing materials such as Pharmacy Manuals, Dosing Instructions, and Drug DiariesContribute to clinical development documents and plans such as protocols, IBs, project plans, etc.Vendor and Stakeholder ManagementManage clinical supply activities outsourced to vendors such as Clinical Manufacturing Organizations and RTSM system vendorsManage vendor selection activities, contract and budget negotiations, invoice reviews/approvals, and the evaluation of performance / metricsIdentify and work with applicable stakeholders to outline and implement risk management strategies to mitigate supply chain disruptionsLeadershipLead Clinical Supply Sub-Team meetings and facilitate communications and decisions regarding clinical supply needs, risks, and issuesIdentify, assess, and proactively communicate supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuityPropose solutions to clinical supply issues, and facilitate decision makingCollaborationCollaborate with key stakeholders (e.g. Program Management, Clinical Operations, Regulatory Affairs, Quality Assurance, and CMC/Manufacturing teams) on the establishment of clinical supply strategies, plans, and tools:Identify central and local depots and regional hubs Develop overall secondary packaging and labeling strategy and operation plan to support program needs including blinded kit packaging and randomization schemes, as appropriateGenerate global distribution plans, including depot inventory, site seeding, and re-supply strategy with appropriate lead-time, expiry dates, and replenishment quantities (via IRT or manually) ComplianceEnsure compliance with regulatory guidelines and Good Manufacturing Practice (GMP) standardsAuthor, review & contribute to SOPs as the business evolves AttributesSelf-motivated Detailed oriented AccountableStrong written and oral communication skills QualificationsBS, preferably in pharmacy, supply chain, or related science degree At least 5 years of experience in clinical supply planning, forecasting, packaging and labeling design, and inventory management using an RTSM systemExperience managing clinical supply vendors and handling contracts and budgetsCommercial supply experience a plus Skills and Abilities Knowledge of GCP, GMP, and GDP regulationsAbility to work and collaborate in a fast-paced, matrixed, team environment and identify and manage stakeholdersAnalytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlinesOversee the continuous evaluation and improvement of our processes as the organization expandsProficient in the use of MS Office suiteExcellent interpersonal skillsBenefits: PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.