Director, Clinical Operations
Clinical Operations | South San Francisco, CA | Full Time
Tolerion is a clinical-stage biopharmaceutical company, located in South San Francisco, with a product portfolio of multiple candidates addressing multiple therapeutic areas. Our product candidates come from our proprietary therapeutic platform which selectively eliminates specific, harmful immune responses while leaving the rest of the immune system intact, a state known as “antigen-specific tolerance." We expect this targeted and selective approach will lead to improved efficacy, safety and tolerability relative to current therapies. With this platform we have created a pipeline of novel product candidates to treat autoimmune diseases in a fundamentally new manner by addressing the root cause of an aberrant immune response. Our lead product candidate, TOL-3021 for the treatment for type 1 diabetes, has completed a Phase 2a clinical trial which showed a promising safety profile and early signals of efficacy. We are currently moving TOL-3021 into advanced clinical development in pursuit of registration. Beyond TOL-3021, we have two additional named clinical candidates selected for advancement into the clinic to treat two additional autoimmune disorders.
Separate from the area of treating autoimmune disease, we have adapted our technology to deliver adjunct solutions capable of inducing specific tolerance in gene therapy settings. Too often promising gene therapy solutions are plagued by immunogenicity that becomes limiting. We have several preclinical programs that demonstrate we can induce immune tolerance in a gene therapy setting, enabling improved efficacy and safety profiles. We own all worldwide marketing, distribution and manufacturing rights to each of our product candidates.
The Director of Clinical Operations will manage the clinical operations team reporting directly to the Chief Medical Officer. The ideal candidate will be an individual with strong clinical trial management experience, who is comfortable with responsibility for managing all aspects of trial operations and knows how to build and manage a core clinical operations team capable of implementing multiple clinical trials simultaneously.
- Coordinate internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
- Manage and mentor the internal clinical operations team
- Manage outsourced activities and approved budgets for clinical studies, such as CROs, vendors, bioanalytical labs and site monitoring to ensure quality deliverables and adherence to study operational plans, timelines, ICH/GCP, protocol requirements and applicable SOPs
- Assist with protocol design and clinical issue resolution
- Contribute to relevant study documentation including clinical protocols, statistical analysis plan, clinical study reports, etc.
- Create and/or review study operational documents/plans (informed consent form, monitoring plan, data management plan, program management plan, etc.)
- Proactively identify project risks and propose risk mitigations with some supervision
- Participate in the selection of sites, CROs, and vendors
- Participate in study data review and other review activities as assigned
- Work closely with other teams in the organization and represent clinical operations in cross-functional initiatives and act on behalf of team, as assigned by management
- Identify program/resource gaps and propose solutions
- Travel required to clinical sites, investigator meetings, medical conferences and otherwise as required from time to time
- Other duties as assigned
Requirements & Experience:
- Bachelor’s degree required, advanced degree preferred with at least 10 years clinical operations experience
- Experience in building, leading and managing a clinical operation function within the context of a science-driven organization
- Must be well organized and able to provide senior operational support across multiple ongoing trials
- Experience with regulatory requirements relative to GCP’s, adverse event reporting and knowledge of FDA regulations
- Proven track record showing excellent clinical project management skills including clinical supply logistics and managing to approved budgets
- Broad understanding of clinical operations in relation to clinical development functions
- Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
- Ability to effectively interface with medical personnel at clinical site(s) and also lead multi-disciplinary teams both internally & externally
- Ability to write technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Advanced computer skills (e.g. MS Word, Excel, PowerPoint; MS Project)
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Tolerion is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process contact the careers email at www.tolerion.bio for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.
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