At a Glance
- Tasks: Lead clinical supply strategy and ensure timely delivery of investigational products for trials.
- Company: Join Jade Biosciences, a pioneering biotech company focused on autoimmune disease therapies.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Other info: Dynamic remote role with travel for team events.
- Why this job: Make a real impact in the biotech field while shaping innovative therapies.
- Qualifications: 15+ years in clinical supply chain management with leadership experience.
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.
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.
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.
- 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.
- 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.
- Select and manage CMOs and suppliers: Select, contract and manage clinical supply CMOs, depots, couriers, logistics providers, and other critical suppliers.
- Oversee clinical supply operations: Direct labeling, packaging, blinding, cold-chain storage and global distribution for all drug product formats.
- Manage IRT and inventory: Define supply requirements for IRT/IxRS systems, including resupply strategies and user acceptance testing.
- Ensure compliance and quality: Maintain full compliance with Jade SOPs, cGMP, GDP, GCP, ICH guidelines and applicable global regulatory and import/export requirements.
- 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.
- Proven experience managing clinical supply for biologics in vials within cold-chain environments.
- Comprehensive understanding of global regulatory and import/export requirements across Europe, North America, China, Japan and Rest of World (ROW).
- Exceptional communication, leadership and interpersonal skills.
- 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.
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.
Executive Director, Clinical Supply Management in Vancouver employer: Jade Biosciences
Jade Biosciences is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the biotechnology sector. With a strong focus on employee growth, you will have the opportunity to lead and mentor a dedicated team while contributing to groundbreaking therapies for autoimmune diseases. The remote nature of this role allows for flexibility, complemented by competitive compensation and a commitment to diversity and inclusion.