Associate Director, Clinical Supply Chain
About the role
thenwith that content. Then "Let’s talk about some of the key responsibilities of the role:" then a list of responsibilities. We'll extract bullet points. Responsibilities list: - Lead end-to-end clinical supply chain strategy and execution across multiple global development programs, providing operational and people leadership for employees and contingent staff supporting clinical supply activities. - Translate clinical development plans and study protocols into phase-appropriate supply strategies covering demand forecasting, manufacturing and release requirements, packaging and labeling, distribution, inventory, resupply, returns, reconciliation, and destruction. - Lead Clinical Supply Team meetings and serve as the primary clinical supply contact for cross-functional planning, issue resolution, risk escalation, and alignment on program and study supply plans. - Manage, coach, and develop clinical supply personnel; set clear objectives, allocate resources across programs, build functional capabilities, and foster a culture of accountability, collaboration, continuous improvement, and commitment to patients. - Develop and maintain scenario-based demand forecasts using enrollment assumptions, dosing regimens, randomization, dropout rates, country and site activation plans, shelf life, lead times, and appropriate supply overage; adjust plans as study assumptions evolve. - Partner with Pharmaceutical Sciences, Technical Operations, Quality, and external manufacturers to align drug-product manufacturing, testing, release, stability, retest and expiry dating, and resupply schedules with clinical demand. - Develop global packaging and labeling strategies, including kit design, blinding, comparator requirements, label content and translations, country-specific requirements, and relabeling or expiry-extension activities at depots and sites, as needed. - Define clinical supply requirements for IRT/RTSM systems, including supply algorithms, inventory parameters, user acceptance testing, system implementation, and ongoing oversight of investigational product throughout study execution. - Select and manage contract packaging organizations, depots, logistics providers, comparator suppliers, and other external partners; establish scopes, budgets, timelines, service expectations, governance, and performance metrics and hold partners accountable for quality, cost, and delivery. - Oversee global distribution and inventory management, including import and export coordination, cold-chain or temperature-controlled logistics, shipment tracking, depot and site inventory, and evaluation and disposition of temperature excursions. - Ensure complete and compliant investigational product accountability, returns, reconciliation, and destruction, with timely resolution of inventory discrepancies and maintenance of inspection-ready documentation. - Develop and maintain SOPs, work instructions, systems, forms, and governance processes for clinical supply management; own or support change controls, deviations, investigations, CAPAs, specifications, and other documentation within the quality management system. - Represent Clinical Supply on cross-functional program and study teams, collaborating closely with Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, Quality Assurance, CMC, Technical Operations, Medical Affairs, Program Management, Finance, Legal, and Procurement to deliver study milestones and resolve supply risks. - Own clinical supply budgets, vendor forecasts, purchase requirements, and operating plans; identify opportunities to improve processes, systems, service models, packaging configurations, and cost efficiency, and support new-asset planning and integration as required. - Perform other related duties as required or assigned. We'll put these in
- . Then "Factors for Success:" then list of qualifications/requirements. We need to separate Requirements, Qualifications, Skills maybe. The instruction: Use headings for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide what content goes where. We have "Factors for Success:" includes education, certifications, experience, expertise, knowledge, etc. This could go under Requirements or Qualifications. Typically Requirements = mandatory experience/education; Qualifications = preferred certifications; Skills = abilities. But we can split. Let's extract: - S./M.S. in Supply Chain, Operations, Pharmaceutical Sciences, Life Sciences, Engineering, or another relevant field. (Education) - APICS certification, formal project management training, and/or Lean Six Sigma certification preferred. (Preferred certification) - A minimum of twelve (12) years of progressively responsible experience in clinical supply chain, clinical supplies, pharmaceutical operations, or related logistics, including experience supporting multiple global clinical studies across early- and late-stage development. (Experience) - Demonstrated expertise in clinical supply planning and forecasting, packaging and labeling, inventory management, global distribution, returns, reconciliation, destruction, and investigational product accountability. (Expertise) - Strong working knowledge of applicable cGMP, GDP, GCP, and global clinical-trial supply requirements, including relevant FDA, ICH, EU, and country-specific expectations. (Knowledge) - Proven experience implementing and managing IRT/RTSM supply functionality and using ERP, inventory-management, forecasting, or supply-planning systems; Oracle NetSuite experience is a plus. (Experience) - Experience managing external packaging, labeling, depot, logistics, comparator-sourcing, and distribution partners, with a track record of establishing effective governance and meeting quality, cost, and schedule commitments. (Experience) - Experience with global temperature-controlled distribution, import/export activities, temperature excursions, shelf-life management, expiry extensions, and relabeling activities. (Experience) - Demonstrated ability to build scenario-based forecasts, interpret complex study assumptions and inventory data, and translate findings into clear supply decisions, contingency plans, and risk-based recommendations. (Ability) - Strong vendor-management, project-planning, budget-management, contracting, and negotiation skills, with the ability to manage multiple programs and studies in a fast-moving matrix organization. (Skills) - Excellent written and verbal communication skills and the ability to influence, align, and make decisions across clinical, scientific, quality, regulatory, supply, finance, and business stakeholders. (Skills) - A pragmatic, hands-on leadership style, exceptional attention to detail, sound judgment, and the ability to move between strategic planning, people leadership, issue resolution, and operational execution. (Leadership style) - Then a list of competencies: Empowering Others, Emotional Intelligence, Grows Capacity, Business Acumen, Innovative Mindset and Action. These are likely leadership competencies; could be under Skills or Qualifications. We'll treat as Skills. Now "A Few Other Details Worth Mentioning:" includes location, hybrid work, remote option, culture, travel up to 15%, benefits, pay range, benefits details. We need Benefits, Pay, Schedule sections. Benefits: health, dental and vision insurance, generous paid time off (vacation, holidays, personal days), onsite gym, pool, snacks, drinks, occasional catered meals. Also link to benefits snapshot (but we should not include application instructions; the link is for benefits details, maybe okay to keep as part of benefits? It's not application instruction; it's a reference. We can keep as part of benefits description. Pay: expected base pay range $150,000 - $210,000 plus bonus, stock equity, and comprehensive benefits. Also note individual pay determined by factors. Schedule: hybrid work environment, remote work option, based in Irvine office, some travel up to 15%. Could be schedule. We should not include boilerplate like EEO, legal, etc. Now we need to output only HTML fragment, no /, no markdown. We'll produce sections in order: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide what goes into Requirements vs Qualifications vs Skills. We can put: Requirements: mandatory education and experience (minimum 12 years, degree). Possibly also "Demonstrated expertise in ..."? Might be better as Qualifications. Qualifications: preferred certifications (APICS, PMP, Lean Six Sigma), Oracle NetSuite experience plus, etc. Skills: vendor management, project planning, budget management, contracting, negotiation, communication, leadership competencies (Empowering Others, Emotional Intelligence, Grows Capacity, Business Acumen, Innovative Mindset and Action), plus ability to build scenario-based forecasts, etc. But we must not invent content; we must preserve all substantive info. So we need to allocate each piece to a section without losing any. Let's list all substantive items from "Factors for Success:" and the competencies. I'll create bullet lists for each. First, Requirements (mandatory): - Minimum of twelve (12) years of progressively responsible experience in clinical supply chain, clinical supplies, pharmaceutical operations, or related logistics, including experience supporting multiple global clinical studies across early- and late-stage development. - S./M.S. in Supply Chain, Operations, Pharmaceutical Sciences, Life Sciences, Engineering, or another relevant field. Maybe also "Demonstrated expertise in clinical supply planning and forecasting, packaging and labeling, inventory management, global distribution, returns, reconciliation, destruction, and investigational product accountability." This is more like a qualification/expertise; could be under Qualifications. But we need to avoid duplication. Let's think: The instruction says "Prefer a few substantive sections over many thin ones." So we could combine Requirements and Qualifications into one? But they ask to use those headings if content exists. We'll try to fill each. We'll assign: Requirements: Education + minimum experience. Qualifications: Preferred certifications (APICS, formal project management training, Lean Six Sigma), Oracle NetSuite experience a plus, demonstrated expertise in the listed areas, strong working knowledge of cGMP/GDP/GCP etc., proven experience implementing and managing IRT/RTSM supply functionality and using ERP etc., experience managing external partners, experience with global temperature-controlled distribution etc., demonstrated ability to build scenario-based forecasts etc. Skills: Strong vendor-management, project-planning, budget-management, contracting, negotiation skills; excellent written and verbal communication skills; ability to influence, align, make decisions across stakeholders; pragmatic hands-on leadership style, exceptional attention to detail, sound judgment, ability to move between strategic planning, people leadership, issue resolution, operational execution; Empowering Others, Emotional Intelligence, Grows Capacity, Business Acumen, Innovative Mindset and Action. Now Benefits: Onsite gym, pool, snacks, drinks, occasional catered meals; hybrid work environment; remote work option; health, dental, vision insurance; generous paid time off (vacation, holidays, personal days); link to benefits snapshot (maybe keep as part of benefits description). Also "We are passionate about our culture! Our Tarsans live our values..." but that's culture fluff; maybe we can include as part of Benefits? It's not a benefit per se but could be considered culture. However instruction: include section only when posting has real, specific content for it. Culture is vague; maybe we skip. Pay: expected base pay range $150,000 - $210,000 plus bonus, stock equity, and comprehensive benefits; individual pay determined by job-related skills, experience, relevant education/training. Schedule: hybrid work environment, remote work option, based in Irvine office, some travel up to 15%. We must not repeat content. Ensure we don't duplicate hybrid/remote in both Benefits and Schedule. Benefits already includes hybrid work environment, remote work option; Schedule also includes those. Might be duplication. Better to put hybrid/remote under Schedule, and benefits only include tangible benefits (gym, pool, snacks, drinks, meals, health insurance, PTO