Senior Clinical Supply Chain Consultant

This is a fully remote position, open to applicants in California, +4 more states.

📋 Description

• Serve as the supply chain lead and Senior Manager of Clinical Supply Chain, integrated within clients’ clinical study teams.

• Collaborate across departments including Clinical Operations, Quality, Regulatory, and CMC teams.

• Oversee clients’ clinical trial supply activities adhering to cGMP, GCP, and GDP, encompassing scheduling for packing and labeling, depot distribution, inventory oversight, IRT management, and protocol interpretation.

• Direct the selection process for pack and label, IRT/RTSM, comparator, and ancillary supply partners.

• Lead cross-functional planning processes such as CD&OP, SIOP, S&OP, and IBP.

• Develop long-term CMC supply plans alongside short-term labeling and distribution schedules, factoring in expiry management and over-labeling.

• Formulate inventory management strategies for clinical sites and depots.

• Identify process inefficiencies and contribute to the creation of SOPs and best practices.

• Conduct study start-up tasks, including IRT/RTSM UAT, activation of countries and sites, depot establishment, and initial site supply.

• Execute study close-out responsibilities, including investigational product reconciliation, returns, and destruction.

• Manage the builds of IRT/RTSM, including protocol requirements, user requirement specifications, UAT scripts and testing, and system modifications.

• Develop work plans in collaboration with the engagement director, supervise execution, and communicate progress to clients and internal stakeholders.

• Evaluate client business processes, operational performance, supply chain frameworks, and financial data.

• Provide strategic advice on clinical supply chain matters to senior client management.

• Act as the main point of contact for clients on a daily basis while mentoring junior consulting staff.

• Engage in the development and presentation of client deliverables.

• Conduct secondary research and analysis on industry trends and practices.

• Contribute to initiatives in Sales, Marketing, and Business Development, including proposal crafting and scoping discussions.

⛳️ Requirements

• Minimum of 7 years’ experience in clinical supply chain management within the biopharmaceutical sector.

• Proven experience in managing complex global trials and formulating labeling and global supply chain strategies.

• Experience in supplying clinical trial materials across various regions including the US, Canada, UK, EU, LatAm, APAC, and MENA.

• Familiarity with planning and coordinating label design and packaging activities with third-party CMO partners.

• Proficient in utilizing and maintaining IRT for the supply chain role; experience with 4G is advantageous.

• Ability to create and manage demand and supply models for clinical trials.

• Experience in selecting and onboarding partners for packaging and/or IRT/RTSM support.

• Knowledge of cold-chain biologics and packaging for cell & gene therapies.

• Experience with inspection readiness and eTMF filing.

• Essential familiarity with diverse medical regulatory environments (FDA, EMA, MHRA) and compliance standards.

• Previous consulting experience is mandatory.

• Proven experience leading workstreams or small teams in a client-facing or consulting context.

• Strong proficiency in Excel and PowerPoint is required.

• Certification in CPIM, CSCP, or Six Sigma is a plus.

• A relevant undergraduate degree is necessary, with an MBA or other advanced degree, or equivalent experience.

🏝️ Benefits

• Competitive salary, aligned with experience.

• Flexible, remote-first working environment.