Role Overview 

The Senior Director, Clinical Operations is responsible for directing the strategy, management, and oversight of clinical program(s) and functional activities as assigned.  

Key Responsibilities 

• Acts as Clinical Operations program lead for assigned program(s) 
• Represent Clinical Operations at the Clinical Development Team and/or Global Program Team
• Develops and executes program operational strategy 
• Partners closely and effectively with other functions and functional heads to drive program forward 
• Provides strategic and technical recommendations to senior leadership 
• Directs the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors) 
• Acts as an escalation point for CRO/vendor issues 
• Directs development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor payments 
• Partners with CRO and other vendors to deliver on study execution 
• Creates and tracks clinical program budgets 
• Directs risk mitigation, escalation, and resolution activities both internally as well as with sites and vendors 
• Directs technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports, etc.)  
• Builds relationships with clinical sites, vendors, and key stakeholders  
• Maintains understanding of external landscape and adjusts plans accordingly 
• Represents Clinical Operations in cross-functional activities as assigned 
• Plays a key role in the development and management of the Clinical Operations function; may act as a deputy for the Head of Clinical Operations as assigned 
• Hires, manages, coaches, and mentors staff 
• Contributes to building the organization 

Qualifications 

• Bachelor's degree in a related field required, an advanced degree is a plus 
• 17+ years of clinical research experience, including 10+ years of trial and/or program-level management within a biopharmaceutical company, and 3+ years of line management experience 
• Exceptional clinical trial & program management skills with a focus on strategic oversight of program execution on time and on budget 
• Extensive experience selecting and managing vendors, including CROs, labs, IxRS, EDC, and ancillary technology/applications (e.g. eDiaries, eConsent, apps, etc) 
• Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials 
• Detailed understanding of all aspects of clinical protocol design, implementation, IND/BLA/NDA submissions, and overall drug development  
• Experience managing, coaching, and mentoring personnel 
• Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration 
• Able to drive decisions forward in times of ambiguity or with incomplete information 
• Effective in promoting and maintaining productive internal and external relationships 
• Proven leadership and team building skills, along with success in proactive risk mitigation and problem solving 
• Flexible and creative to meet the needs and challenges of a growing, dynamic company 
• Demonstrated problem solving abilities 
• Proven ability to influence up, down, and across the organization 
• Strong financial acumen with outstanding track record of building budgets and managing expenses to budget 
• Study coordinator and/or site monitoring experience a plus 
• Thrives in a small company environment, where day-to-day duties go above and beyond this job description 
• May contribute to corporate activities, e.g. preparation for Board of Director meetings 

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 $255,000 – $280,000. The final salary offered will depend on several factors, which may include, but is 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. 

Role Overview 

We are seeking highly skilled, and motivated Director of Combination Product & Device Development, to lead the development, manufacturing, assembly and commercialization of high‑concentration biologic delivery systems, including, prefilled syringes, autoinjectors and other drug–device combination products.

The ideal candidate brings deep expertise in device design control, verification and validation, risk management, combination product regulations, and human factors engineering. This role requires hands‑on technical leadership and extensive experience with regulated devices and combination products (21 CFR 820, ISO 13485), as well as strong knowledge of global device standards (ISO, IEC 62366, ANSI/AAMI HE75) and FDA guidance. A successful track record supporting major regulatory submissions (BLA, MAA, IND/IMPD) and notified body assessments is essential.

Key Responsibilities 

Device Development

• Lead end‑to‑end development and commercialization of prefilled syringes, dual‑chamber cartridges, autoinjectors, and related combination product systems.
• Serve as a hands‑on technical leader and device SME across concept, feasibility, development, qualification, and launch phases.
• Define user needs and product requirements; lead prototyping, test method development, and design verification and validation (DV/V) activities.
• Drive design control documentation, risk assessments, usability studies, and human factors integration.
• Collaborate deeply with internal partners across CMC, drug product development, quality assurance, regulatory affairs, clinical development, supply chain, and commercial functions.
• Build and manage external relationships with CDMOs, device manufacturers, design firms, and suppliers to support development and lifecycle needs.
• Support lifecycle management of commercial combination products, including design history file (DHF) maintenance, change control, validation activities, complaint investigations, and post‑market surveillance.
• Evaluate technical decisions for cross‑functional impact and implement contingency plans as needed.
• Proactively identify and address manufacturing issues; coordinate technical solutions across internal and external teams.
• Lead creation of design control deliverables to ensure compliance with global device and combination product regulations.
• Oversee development of statistically sound verification protocols, reports, and design validation strategies.
• Lead or contribute to investigations of deviations, failures, complaints, and device‑related quality issues.

Design Controls & Human Factors

• Serve as the organizational expert in Human Factors Engineering, ensuring compliance with IEC 62366, ANSI/AAMI HE75, FDA guidance, and related industry standards.
• Integrate usability, human performance considerations, and safety risk mitigations into system requirements and development strategies.
• Ensure all human factors processes, deliverables, and standards are appropriately documented within the Design Control Quality System.
• Lead the cross‑functional design control sub‑team and drive cohesive integration across device design, analytical testing, packaging, manufacturing, clinical, supply chain, commercial, and regulatory functions.
• Manage and prioritize multiple concurrent projects, ensuring alignment to scope, timelines, budgets, and quality standards.

Regulatory Support

• Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks (e.g., EDDO, MDR).
• Author device‑related sections for regulatory submissions (BLA, MAA, IND/IMPD) and support notified body interactions.
• Represent the combination product function during regulatory audits and inspections.
• Lead proactive risk identification, mitigation planning, and escalation of critical issues.
• Demonstrate strong understanding of FDA’s Office of Combination Products (OCP), including primary mode of action (PMOA) requirements and combination product complaint expectations.

Qualifications 

• Master’s degree (or equivalent) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related field.
• 15+ years of experience in biologic delivery device development with a proven record of supporting late‑stage development and commercial product launches.

• Experience with design controls, device risk management, medical devices, prefilled syringes, autoinjectors, and related scientific and technical concepts and techniques is required for this position.
• Deep knowledge of subcutaneous delivery systems, systems engineering principles, device materials, and manufacturing technologies; experience with biologics and packaging development preferred.
• Strong understanding of FDA and EU regulations for medical devices and combination products, including relevant quality systems and standards.
• Experience managing external partners, vendors, and contract manufacturers.
• Proven experience with cGMP process development, manufacturing controls, and process risk assessments.
• Excellent communication, leadership, and cross‑functional collaboration skills.
• Ability to thrive in a fast‑paced, agile environment; start‑up experience is highly desirable.

Position Location 

This is a fully remote role with up to 15-20% domestic and/or international travel.

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

Role Overview 

We are seeking a Director of Clinical Supply Chain to lead end-to-end clinical supply execution for a global late-stage clinical trial. This role will have full ownership of clinical supply strategy and execution, from demand forecasting through distribution, for programs involving prefilled syringes (PFS) and autoinjectors. The successful candidate will be comfortable operating within a fast-paced environment and partnering closely with Clinical Operations, Quality, CMC, and external vendors to ensure uninterrupted drug supply for our studies. This is a great opportunity to own a critical late-stage program with real patient impact and to have the ability to shape clinical supply strategy during a pivotal stage of the company’s evolution.

Key Responsibilities 

Clinical Supply Strategy & Execution

• Own the global clinical supply strategy for late-stage programs, including demand forecasting, inventory management, and risk mitigation.
• Develop and maintain integrated supply plans aligned with enrollment forecasts, dosing schedules, and protocol amendments.
• Ensure seamless transition and continuity of drug supply.

Drug Product Development

• Lead clinical supply activities for vials, prefilled syringes (PFS), and autoinjectors, including:
• Device assembly and packaging considerations
• Cold-chain (2–8°C) requirements
• Labeling, blinding, and re-supply strategies
• Partner with CMC and device vendors to support lifecycle changes, comparability, and scale-up impacts to clinical supply.

Vendor & Depot Management

• Manage external partners including:
• Packaging and labeling vendors
• Global depots and regional distribution hubs
• Couriers and specialty logistics providers, as appropriate
• Lead vendor selection, SOWs, budgets, timelines, and performance oversight.
• Ensure qualified shippers, temperature monitoring, excursion management, and deviation handling are done in a compliant manner.

Distribution & Regulatory Compliance

• Oversee global distribution across multiple regions, ensuring:
• Country-specific import/export requirements
• QP release and EU clinical supply compliance where applicable
• Ensure inspection-ready documentation and robust supply chain traceability.

Cross-Functional Leadership

• Serve as the clinical supply chain lead on cross-functional study teams.
• Partner closely with:
• Clinical Operations on enrollment and site strategy
• Quality on GMP/GDP compliance and deviations
• Regulatory and CMC on changes impacting supply
• Communicate risks, mitigations, and trade-offs clearly to senior leadership.

Qualifications 

• Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience
• 10+ years of experience in clinical supply chain / clinical supply operations.
• Direct experience managing Phase 3 clinical trials, including global distribution.
• Hands-on experience with prefilled syringes (PFS) and/or autoinjectors in a clinical trial setting.
• Demonstrated ownership of:
• Forecasting and supply planning
• Packaging, labeling, and distribution
• Vendor and depot management
• Strong understanding of GMP/GDP, ICH-GCP, and global clinical supply requirements.
• Cold-chain biologics experience (2–8°C).
• Experience transitioning programs toward commercial readiness.
• Demonstrated ability to balance strategy and execution.
• An ownership mindset, ability to anticipate risk and solve problems proactively.
• Clear communication skills and the ability to translate supply complexity into actionable decisions.

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 $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

Role Overview 

The Associate Director, Quality Control will lead critical Quality Control functions to support Jade’s product pipeline across various stages of development. The Associate Director will manage analytical method life cycle including method development, qualification, transfer and validation as phase appropriate. This individual will work very closely with internal stakeholders and external CDMO partners and will be responsible for developing and executing product release testing, stability study and product shelf-life management strategy whileensuring full quality compliance with regulatory requirements and internal quality systems.

Key Responsibilities 

• Work with both internal (Manufacturing, Quality Assurance, Regulatory and other key stakeholders) and external CDMO partners to develop and implement QC strategies appropriate for different phases of development programs
• Oversee analytical method development, qualification, transfer and validation activities at and cross CDMOs

• Develop product specifications and oversee product in-process, release, and stability testing strategy and execution in compliance with both cGMP and ICH guidance and internal quality standard
• Work with Quality Assurance to create and manage QC documentation including SOPs, protocols, and technical reports
• Collaborate cross-functionally with Manufacturing, QA, Regulatory, and R&D to support tech transfers and lifecycle management, regulatory filing and interactions etc.
• Manage CDMO relationships to ensure compliance with quality standards, timely deliverables, and effective communication
• Review and approve CDMO generated data, investigations, and documentation
• Ensure timely investigation and resolution of OOS results, deviations, and CAPAs
• Serve as QC subject matter expert during regulatory inspections and audits

Qualifications 

• Master’s or advanced degree in Chemistry, Biology, Biochemistry, or related field with 10+ years of related experience (7+ years of experience with PhD)

• 8+ years of experience in Quality Control management within the biotech or pharmaceutical industry
• A strong quality compliance and collaborative mindset, and ability to thrive in a fast-paced working environment
• Strong knowledge of cGMP, FDA, EMA, and ICH regulations
• Strong experience in analytical method life cycle management including phase appropriate method qualification, transfer and validations from early to late phase development including BLA filing
• Experience with common analytical techniques such as HPLC/UPLC, CE-SDS, ELISA, and cell-based assays for biologics development
• Proven leadership in managing internal QC operations or external CDMOs  
• Excellent communication, organizational, and problem-solving skills

Position Location 

This is a fully remote role with up to 20% domestic and/or international travel.

The anticipated salary range for candidates for this role is $170,000 - $190,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

Role Overview 

The Associate Director, Clinical Site Budgets & Payments will architect and lead the company’s global approach to clinical trial site budgeting, investigator grant strategy, transparency compliance, and site/vendor payment governance across our clinical trial portfolio. This leader will define Jade’s global investigator grant philosophy, including structured opening offer and negotiation parameters that ensure speed, fairness, and alignment with global FMV benchmarks.  They will establish standards for invoiceables, conditional procedures, pass‑through costs, and country‑specific budgeting norms that apply across all Jade clinical studies.

This role oversees a full‑service CRO partner responsible for operational execution of budgets, payments, reconciliation, and study financial controls. It also builds and maintains global site budget forecasts, ensures just‑in‑time CRO funding, and supports accruals, reconciliation, and inspection‑readiness.

The successful candidate must be equally fluent in clinical trial protocols and financial statements, highly skilled in influencing cross‑functional and vendor partners, and able to uphold strict compliance with FMV and Sunshine/Open Payments regulations. This is a high‑visibility, individual‑contributor role reporting directly to the Executive Director, Development Outsourcing and operating globally across all Jade studies. The position is remote, with domestic travel up to four times per year.

Key Responsibilities 

Global Payment Philosophy, Compliance & Governance

• Define Jade’s global investigator grant strategy, including opening‑offer tiers, decision and negotiation parameters, aligned with international FMV standards.
• Establish and maintain policies for invoiceables, pass‑throughs, conditional procedures, screen‑fail handling, and complex visit structures; ensure global consistency.
• Develop and maintain SOPs/WIs governing budgeting, payments, documentation, and global transparency requirements (e.g., U.S. Sunshine/Open Payments and ex‑US equivalents).
• Define FMV justification expectations and ensure audit‑ready documentation across all investigator/HCP engagements.

Study‑Level Budget Design & Financial Oversight

• Translate clinical protocols into country‑specific and site‑level cost models that accurately reflect procedures, visit schedules, and conditional events.
• Build and maintain global study budget forecasts, partnering closely with Clinical Operations and Finance to ensure alignment with development plans.
• Implement and monitor just‑in‑time CRO funding, minimizing idle cash at CROs while ensuring on‑time site payments.
• Oversee accruals, spend tracking, payment reconciliation, and close‑out documentation for accuracy and inspection readiness.

CRO Governance & Issue Escalation

• Serve as Jade’s primary owner of CRO performance for site budgets and payments, including contract expectations, KPIs, and service delivery standards.
• Lead the payment‑related components of CRO governance forums, including issue resolution, aging analysis, cycle‑time performance reviews, and payment forecasting.
• Resolve escalated site payment issues, driving sustainable root‑cause solutions and process improvements.

HCP/KOL Payment Operations (“White‑Glove” Model)

• Implement a high‑touch service model for KOL/HCP payments (consulting, advisory boards, speaking engagements), ensuring accuracy, speed, and FMV alignment.
• Streamline administrative burden for external experts by simplifying processes, documentation, and support.

Cross‑Functional Leadership & Decision Support

• Partner closely with Clinical Operations, Development Outsourcing, Legal, Compliance, and Finance to ensure budgets and payments reflect protocol intent, operational realities, and compliance needs.
• Provide executive‑level visibility into performance metrics such as payment timeliness, disputes, forecast accuracy, and CRO funding utilization.
• Serve as Jade’s internal subject‑matter expert for investigator/HCP budgeting and payment strategy across a global two‑program portfolio in Autoimmune disease.

Qualifications 

• Bachelor’s degree in finance, life sciences, business, or related field with 13+ years of experience or an advanced degree (MBA, MS, MPH) with 10+ years of experience.
• 10+ years of relevant experience in biotech/pharma or CRO roles with direct responsibility for site budgeting and payment oversight
• Demonstrated ability to interpret clinical protocols and convert them into robust, compliant global site budgets
• Strong understanding of global FMV frameworks and Sunshine/Open Payments transparency requirements.
• Proven experience governing a full service CRO, including KPI management, escalation handling, and process improvement.
• Ability to analyze financial statements, accruals, and cash flow impacts.
• Excellent communication, negotiation, and cross functional influence.
• Experience supporting Autoimmune or immune mediated diseases preferred.
• Experience managing global payment models across diverse regulatory environments preferred.
• Exposure to KOL/HCP engagement processes with FMV and transparency considerations preferred.

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 $170,000 - $190,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. 

Role Overview 

The Executive Director, Clinical Quality Assurance (CQA) will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GPvP) and Good Laboratory Practices (GLP) activities to ensure quality assurance and compliance of Jade sponsored clinical trials with applicable regulations, ICH guidelines, OECD Principles of GLP, Jade procedures and policies, and current industry standards and practices.

The Executive Director, Clinical Quality Assurance will perform day-to-day clinical quality operations and compliance activities to support the success of our clinical programs in addition to being a strategic partner to Clinical Development and Operations. This role will maintain and ensure effectiveness of quality programs and documentation to assure compliance and inspection readiness with all applicable quality requirements and regulatory standards. The ideal candidate brings hands-on expertise in GCP, GPvP and GLP QA operations, a proactive approach to problem-solving, and the ability to guide and influence cross-functional teams while upholding the highest standards of quality and compliance.

Key Responsibilities

• Provide hands on clinical QA oversight and review of protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents.
• Provide coaching, Quality decisions and be Quality approver to study teams on protocol deviations, vendor oversight, CAPAs, and issue management.
• Act as the primary GCP/GPvP/GLP QA subject matter expert and point of contact for all related matters and issues.
• Represent Quality on project teams, service providers and CROs operational meetings, and QA to QA meetings.
• Oversee ongoing clinical programs to ensure they are risk‑based, fit‑for‑purpose and in compliance with applicable regulations and guidelines across all phases of development.
• Review and approve (as appropriate) procedures, service provider quality agreements, qualification and onboarding forms and regulatory filings.
• Develop, implement and execute a risk-based audit strategy and detailed plans for clinical and non-clinical studies.
• Establish and maintain GCP/GPvP/GLP QA programs, policies and procedures.
• Work collaboratively with the internal Clinical Operations Team and Development Teams to provide leadership and guidance to support study execution, data integrity, and regulatory compliance.
• Identify and assess compliance risk and develop and implement risk mitigation measures.Lead the identification, investigation (root cause analysis), and resolution of quality issues through a robust investigation and CAPA process.
• Contribute to building a strong quality culture within the organization.
• Ensure the timely and effective follow up of all identified or assigned quality issues.
• Direct and/or deliver yearly training for internal staff as needed.
• Work closely with Development, Clinical Operations, and other functions/departments to drive inspection readiness and support regulatory interactions.
• Champion continuous improvement and simplification across clinical quality systems.
• Prepare KPIs, metrics and analysis and present status updates as needed.
• Provide leadership in inspection preparedness to clinical sites and service providers for regulatory government agencies.
• Stay current on global regulations, industry trends, and best practices to ensure continuous improvement and innovation within the QA function.
• Apply risk‑based thinking to identify the quality activities that meaningfully influence study outcomes, rather than defaulting to checklists or bureaucracy.
• Understand when to escalate, when to intervene, and when to let teams move forward without over engineering processes.
• Provide clear, concise guidance that helps teams stay focused, aligned, and inspection ready.

Qualifications 

• Bachelors + 17 or Masters + 15 or PhD + 10 years of related experience Extensive expertise in GCP, GPvP, GLP and ICH clinical requirements, clinical development and methodologies of clinical studies.
• Successful track record of translation and implementation of clinical requirements into operational execution.
• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• A successful track record of working with service providers and CROs.
• Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Ability to tactically and strategically execute the day-to-day operations to support clinical trials and clinical and non-clinical development activities. 
• Knowledge of Quality Management Systems; experience in building, implementing and managing quality systems in the pharmaceutical industry.
• Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).
• Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.
• Strong organizational skills and the ability to participate effectively cross-functionally.
• A self-starter and a team player who thrives in a fast-paced dynamic team environment.
• Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others. Prior management experience is required.
• Previous experience in successfully leading assigned activities within cross-functional teams.
• Proficiency in using SharePoint, Veeva and Microsoft Office applications required (MS Outlook, MS Word, MS Excel, MS PowerPoint).

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 $265,000 - $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.