Senior Director, Clinical Operations
About The Position
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.
Requirements
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Director
