Trova la tua prossima opportunità

About Jade Biosciences Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an anti-IFN-β monoclonal antibody. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn. Role Overview Jade is developing potentially transformational, disease-modifying therapies for people living with autoimmune diseases. With three biologics programs in the clinic and multiple ongoing studies from Phase I to Phase III, we are seeking an experienced Executive Director, Clinical Supply Management to join our CMC leadership team and make sure every patient in our trials receives the right investigational product, on time. Reporting to the Chief Technology Officer (Head of CMC), you will own clinical supply strategy, planning and execution for all Jade programs. You will shape and scale the Clinical Supply Management function, growing and mentoring a team of internal employees and contractors, and you will lead a global network of CMOs and logistics partners supporting complex, multi-country and multi-site studies with ambitious timelines and enrollment targets. This is a high-impact role for a self-starter who combines strategic thinking with hands-on execution. You will work closely with Clinical Operations and Clinical Development to secure supply for every planned study, help prepare the supply chain for BLA filing, launch and commercial readiness, and contribute directly to Jade’s key corporate goals. Key Responsibilities Lead and build the function: Provide strategic and operational leadership for Jade’s Clinical Supply Management function. Further develop and scale the team through a combination of internal headcount and external partners, including recruiting, onboarding and mentoring team members and consultants. Develop robust business processes and SOP in close collaboration with the Quality function. Define the clinical supply strategy: Develop and implement the clinical supply strategy for all Jade programs, from early-stage (Phase 1/2) through late-stage (Phase 3) development, with a forward-looking view toward BLA filing, product launch and commercial readiness. Plan demand and supply: Build and maintain integrated global demand forecasts and supply plans based on protocols, enrollment projections and site activation plans. Balance drug product availability, shelf life, overage and cost, and update plans as studies evolve. Advise on potential risk and challenges to Senior Management and peer groups such as Clinical Operations and Development. Collaborate cross-functionally: Partner closely with Clinical Operations and Clinical Development on study-specific supply strategies, and with Quality, Regulatory Affairs and CMC to forecast, align and continuously update supply requirements for ongoing and future studies. Develop options and recommendations for stakeholders and senior management. Select and manage CMOs and suppliers: Select, contract and manage clinical supply CMOs, depots, couriers, logistics providers, and other critical suppliers. Set clear performance expectations and KPIs, and build strong partnerships that ensure quality, reliability and cost-effective supply. Oversee clinical supply operations: Direct labeling, packaging, blinding, cold-chain storage and global distribution for all drug product formats, including vials, pre-filled syringes and autoinjectors. Manage comparator sourcing, expiry extensions, relabeling, returns, reconciliation and destruction. Manage IRT and inventory: Define supply requirements for IRT/IxRS systems, including resupply strategies and user acceptance testing, and monitor inventory at depots and sites to prevent stock-outs and minimize waste. Ensure compliance and quality: Maintain full compliance with Jade SOPs, cGMP, GDP, GCP, ICH guidelines and applicable global regulatory and import/export requirements. Partner with Quality on batch release (including QP release for EU studies), deviations and change controls, keep the function inspection-ready, and contribute to regulatory submissions (IND, IMPD, CTA). Own the budget and reporting: Manage the clinical supply budget, and report regularly and concisely to stakeholders and senior management on inventory, supply and demand, changes and risks across all programs. Qualifications Bachelor’s or Master’s degree (or equivalent) in Life Sciences, Chemical Engineering or a related field. 15+ years of progressive experience in clinical supply chain management, ideally with biologics, including significant experience leading teams. Experience in commercial supply chain management is a plus. Proven experience managing clinical supply for biologics in vials within cold-chain environments, using local and multinational CMOs; experience with pre-filled syringes and combination products such as autoinjectors highly preferred. Experience supporting multiple early- and late-stage programs, including multi-country Phase 3 studies and bridging studies for biologic combination products. Comprehensive understanding of global regulatory and import/export requirements across Europe, North America, China, Japan and Rest of World (ROW), and strong working knowledge of cGMP, GDP and GCP. Hands-on experience with IRT/IxRS systems, clinical supply forecasting tools and budget management. Demonstrated success building and scaling clinical supply functions, including hiring, onboarding and managing team members and consultants to meet critical milestones. Exceptional communication, leadership and interpersonal skills, with a track record of aligning CMC, Quality, Regulatory Affairs and Clinical teams and building trusting relationships with external CMO partners. A strategic thinker with a proven execution record, strong problem-solving skills and the ability to thrive in a complex, fast-paced clinical development environment. Position Location This is a remote role; periodic travel to team and company events is required. The anticipated salary range for candidates for this role is $280,000 - $300,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster. Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Originally posted on Himalayas