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About the Role

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 ensure every patient in our trials receives the right investigational product, on time. You will own clinical supply strategy, planning and execution for all Jade programs, shape and scale the Clinical Supply Management function, and lead a global network of CMOs and logistics partners.

Responsibilities

Provide strategic and operational leadership for Jade’s Clinical Supply Management function.
Develop and scale the team through internal headcount and external partners, including recruiting, onboarding and mentoring.
Develop robust business processes and SOPs in collaboration with the Quality function.
Develop and implement the clinical supply strategy for all Jade programs, from early-stage through late-stage development, with a forward-looking view toward BLA filing, product launch and commercial readiness.
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 risks and challenges to Senior Management and peer groups.
Partner closely with Clinical Operations and Clinical Development on study-specific supply strategies.
Collaborate with Quality, Regulatory Affairs and CMC to forecast, align and continuously update supply requirements.
Develop options and recommendations for stakeholders and senior management.
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.
Direct labeling, packaging, blinding, cold-chain storage and global distribution for all drug product formats.
Manage comparator sourcing, expiry extensions, relabeling, returns, reconciliation and destruction.
Define supply requirements for IRT/IxRS systems, including resupply strategies and user acceptance testing.
Monitor inventory at depots and sites to prevent stock-outs and minimize waste.
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, deviations and change controls.
Keep the function inspection-ready, and contribute to regulatory submissions.
Manage the clinical supply budget, and report regularly and concisely to stakeholders and senior management on inventory, supply and demand, changes and risks.

Requirements

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).
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.

Skills

Clinical Supply Management
Biologics
Team Leadership
Commercial Supply Chain Management
Cold Chain Management
Pre-filled Syringes
Autoinjectors
Global Regulatory Requirements
Import/Export Requirements
cGMP
GDP
GCP
IRT/IxRS Systems
Clinical Supply Forecasting
Budget Management
Communication Skills
Leadership Skills
Interpersonal Skills
Problem-Solving Skills

Location

Remote

Work Type

Remote
Full-time

Experience Level

Executive Director
15+ years experience

Education Level

Bachelor's degree
Master's degree

Salary/Compensations

$280,000 - $300,000

Benefits

Periodic travel to team and company events

About the Company

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.

Equal Opportunity

Jade Bioscience participates in E-Verify.
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.