Senior Director, Clinical Operations

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 in a Phase 1 clinical trial 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 undisclosed antibody candidate, both currently in preclinical development. 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 

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. 
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.