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.