pmvpharma
Title/Position: Associate Director, Clinical Supply Management
pmvpharma, Princeton, New Jersey, us, 08543
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 labeling, and distribution strategies. Liaise with CMC on DP forecasting to ensure adequate long term bulk drug product availability. Operational Execution and Oversight
Manage 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 PMV. Proactively address the impact of regulatory and clinical updates during clinical trial conduct and adjust clinical supplies forecast and plans accordingly. Contribute 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 issues. Develop 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 documents. Author and/or review site-facing materials such as Pharmacy Manuals, Dosing Instructions, and Drug Diaries. Contribute to clinical development documents and plans such as protocols, IBs, project plans, etc. Vendor and Stakeholder Management
Manage clinical supply activities outsourced to vendors such as Clinical Manufacturing Organizations and RTSM system vendors. Manage vendor selection activities, contract and budget negotiations, invoice reviews/approvals, and the evaluation of performance / metrics. Identify and work with applicable stakeholders to outline and implement risk management strategies to mitigate supply chain disruptions. Leadership
Lead Clinical Supply Sub-Team meetings and facilitate communications and decisions regarding clinical supply needs, risks, and issues. Identify, assess, and proactively communicate supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity. Propose solutions to clinical supply issues, and facilitate decision making. Collaboration
Collaborate 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 appropriate. Generate 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). Compliance
Ensure compliance with regulatory guidelines and Good Manufacturing Practice (GMP) standards. Author, review & contribute to SOPs as the business evolves. Attributes
Self-motivated. Detail oriented. Accountable. Strong written and oral communication skills. Qualifications
BS, 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 system. Experience managing clinical supply vendors and handling contracts and budgets. Commercial supply experience a plus. Skills and Abilities
Knowledge of GCP, GMP, and GDP regulations. Ability to work and collaborate in a fast-paced, matrixed, team environment and identify and manage stakeholders. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Oversee the continuous evaluation and improvement of our processes as the organization expands. Proficient in the use of MS Office suite. Excellent interpersonal skills. Benefits
PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.
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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 labeling, and distribution strategies. Liaise with CMC on DP forecasting to ensure adequate long term bulk drug product availability. Operational Execution and Oversight
Manage 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 PMV. Proactively address the impact of regulatory and clinical updates during clinical trial conduct and adjust clinical supplies forecast and plans accordingly. Contribute 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 issues. Develop 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 documents. Author and/or review site-facing materials such as Pharmacy Manuals, Dosing Instructions, and Drug Diaries. Contribute to clinical development documents and plans such as protocols, IBs, project plans, etc. Vendor and Stakeholder Management
Manage clinical supply activities outsourced to vendors such as Clinical Manufacturing Organizations and RTSM system vendors. Manage vendor selection activities, contract and budget negotiations, invoice reviews/approvals, and the evaluation of performance / metrics. Identify and work with applicable stakeholders to outline and implement risk management strategies to mitigate supply chain disruptions. Leadership
Lead Clinical Supply Sub-Team meetings and facilitate communications and decisions regarding clinical supply needs, risks, and issues. Identify, assess, and proactively communicate supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity. Propose solutions to clinical supply issues, and facilitate decision making. Collaboration
Collaborate 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 appropriate. Generate 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). Compliance
Ensure compliance with regulatory guidelines and Good Manufacturing Practice (GMP) standards. Author, review & contribute to SOPs as the business evolves. Attributes
Self-motivated. Detail oriented. Accountable. Strong written and oral communication skills. Qualifications
BS, 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 system. Experience managing clinical supply vendors and handling contracts and budgets. Commercial supply experience a plus. Skills and Abilities
Knowledge of GCP, GMP, and GDP regulations. Ability to work and collaborate in a fast-paced, matrixed, team environment and identify and manage stakeholders. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Oversee the continuous evaluation and improvement of our processes as the organization expands. Proficient in the use of MS Office suite. Excellent interpersonal skills. Benefits
PMV provides a competitive medical benefits package, a generous PTO policy, competitive salaries, Employee Stock Purchase Plan, Employee Referral Program, and much more.
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