Job Description
Job Description
Job Title: Associate/Director, Clinical Operations
Job Location: San Francisco, CA, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Director
About Jade Biosciences
Jade Biosciences is focused on developing best-in-class therapies to address critical unmet needs in autoimmune diseases. Our lead asset, JADE-001, targets the anti-A PRoliferation-Inducing Ligand (APRIL) pathway for immunoglobulin A (IgA) nephropathy, with Investigational New Drug Application-enabling studies underway and initiation of a first-in-human trial expected in the second half of 2025. Jade’s pipeline also includes two undisclosed optimized antibody discovery programs, JADE-002 and JADE-003, 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 us on LinkedIn.
POSITION
This position will be responsible for directing the strategy, management, and oversight of clinical trial(s) and functional activities as assigned.
Key Responsibilities
- Acts as Clinical Operations trial lead for assigned trial(s)
- Leads cross-functional Study Execution Teams
- Develops and executes trial operational strategy
- Partners closely and effectively with other functions to drive trial forward
- Provides strategic and technical recommendations to senior leadership
- Directs the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors)
- Directs development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor payments
- Partners with CRO and other vendors to deliver on trial execution
- Creates and tracks clinical trial 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
- Supports development and management of the Clinical Operations function
- Coaches and mentors more junior team members such as Clinical Trial Associates
- Contributes to building the organization
- 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
- 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
Qualifications And Experience
- Bachelor's degree in a related field required
- Advanced degree a plus
- For the Associate Director level: 10+ years of clinical research experience including 7+ within a biopharmaceutical company and/or CRO; for the Director level: 15+ years of clinical research experience including 10+ within a biopharmaceutical company and/or CRO
- Exceptional clinical trial management skills with a focus on strategic oversight of trial 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
- Study coordinator and/or site monitoring experience a plus
- 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
POSITION LOCATION
This is a remote role based in Bay Area, CA or Seattle, WA; periodic travel to team and company events is required.
The anticipated salary range for candidates for this role is $170,000-$190,000 for the Associate Director level and $210,000-$230,000 for the Director level position. 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.
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