Jade Biosciences logo
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.

Senior Director, Clinical Operations

Threat Intelligence SpecialistSecurity AnalystFull TimeRemoteTeam 11-50

Location

United States

Posted

19 days ago

Salary

Not specified

No structured requirement data.

Job Description

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

Job 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
  • 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.

Benefits

  • As part of the I-9 verification of authorization to work in the United States, Jade Bioscience participates in E-Verify.
  • 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.

Related Job Pages

More Threat Intelligence Specialist Jobs

evo logo

Merchandising Operations Manager

evo

At evo, we are working to build and nurture a culture where equity, inclusivity, and compassion are inherent to how we operate and evolve. We recognize and value the uniqueness of each individual's experiences and understand the power in the diversity of ideas and opinions. Guided by our values and mission to promote more inclusive outdoor spaces, we are working to develop a team that is equally representative of the community we hope to build. While there is more work to be done, we are in the process of evolving our toolset. We are committed to providing the space, support, and resources necessary for each individual to feel heard and valued. If you are interested in contributing your unique voice to our journey, we welcome you to apply! evo is an equal opportunity employer. We believe the participation of individuals of diverse ages, races, religions, cultures, abilities and personalities will add to personal development and organizational success. All employees and potential employees will be recruited, selected, trained, and promoted without regard to sex, sexual orientation, race, religion, marital or military status, age, national origin, color, the presence of any mental, physical, or sensory disability, genetic information, gender identity, political ideology, or any other basis prohibited by law. The base wage for this role ranges from $100,000.00/yr to $125,000.00/yr. Where you land in that range depends on your skills and experience, and we also factor in internal pay equity. While the full range is listed for this role, we rarely hire at the top of the range, leaving room for professional and financial growth in role. At evo, we continually evolve our pay process and total rewards offerings to ensure pay is fair and easy to understand. While every individual's needs are unique, we are proud to offer a benefits package that has been carefully curated to support both your personal life and professional aspirations.

Threat Intelligence Specialist19 days ago
Full TimeRemote

The Merchandising Operations Manager – Partner Fulfilled Programs owns the operational execution, governance, and scalability of evo’s partner-fulfilled commerce models. Ensures that non-owned and partner-supplied assortments launch on time, transact cleanly, and meet evo’s custo...

United States
Pearl logo

Appointment Setter & Executive Assistant

Pearl

The future of dentistry, powered by AI.

Threat Intelligence Specialist19 days ago
Full TimeRemoteTeam 51-200H1B Sponsor

The Appointment Setter & Executive Assistant is a high-performance, operations-heavy Executive Assistant role supporting leadership and sales teams in a fast-moving enterprise environment. You will serve as the operational backbone of daily execution while contributing to strateg...

United States + 24 moreAll locations: United States, Brazil, Colombia, Argentina, Chile, Venezuela, Bolivarian Republic Of, Bolivia, Plurinational State Of, Ecuador, French Guiana, Guyana, Paraguay, Peru, Suriname, Uruguay, Mexico, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama, Dominican Republic, Puerto Rico
Threat Intelligence Specialist19 days ago
ContractRemoteTeam 51-200

Description Supports and develops county Farm Bureau membership and programming by building relationships, developing programs, planning events and managing county communications to promote agriculture in the local community. Provides administrative assistance for the assigned co...

United States
Threat Intelligence Specialist19 days ago
Full TimeRemote

Il tuo ruolo come Group Leader: Accompagnerai gruppi di ragazzi in partenza dall’Italia verso destinazioni europee ed extraeuropee, seguendoli in ogni fase: Dalla partenza al ritorno, offrendo assistenza durante tutto il viaggio. Durante la permanenza nei college, guidandoli nell...

United States + 43 moreAll locations: United States, United Kingdom, Germany, France, Estonia, Portugal, Hungary, Poland, Ukraine, Romania, Bulgaria, Czech Republic, Slovakia, Belarus, Moldova, Republic Of, Sweden, Greece, Belgium, Italy, Ireland, Switzerland, Netherlands, Finland, Malta, Denmark, Lithuania, Croatia, Spain, Austria, Bosnia And Herzegovina, Iceland, Luxembourg, Macedonia, The Former Yugoslav Republic Of, Montenegro, Norway, Serbia, Slovenia, Albania, Cyprus, Latvia, Monaco, Japan