Director, Clinical Science
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, Clinical Science will oversee the strategy and execution of all clinical trials. The Director will ensure alignment between clinical strategy and clinical study protocols, operational structure and operating procedures.
- Lead the clinical sciences function at Tolerion
- Provide strategic direction and lead staff in design and execution of Phase 1, 2 and 3 clinical studies, consistent with corporate objectives and procedures
- Coordinate internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
- Conduct data review, analysis and interpretation
- Perform and document regular study data reviews and other review activities
- Author key clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR, BLA) as well as prepare strategy presentations, present and discuss data with governance, external consultants, KOLs and potentially within regulatory meetings in conjunction with members of the development team
- Interface with SMEs in discovery, statistics, translational medicine, safety sciences, regulatory, clinical operations, clinical supplies, health economics and outcomes research, business, internal governance, external experts and regulators.
- Create and/or review study documents/plans (monitoring plan, data management plan, safety review plan, etc.)
- Proactively identify clinical development risks and propose risk mitigations
- Participate in the selection of sites, CROs, and vendors
- Travel for study team meetings and to clinical sites for co-monitoring may be required
- Other duties as assigned
Requirements & Experience:
- Advanced scientific degree in Life Sciences preferred (PhD, MD)
- 10+ years in clinical development experience in the biotechnology or pharmaceutical industries
- Experience with and understanding of relevant ICH guidance and CFRs
- Ability to author and manage team review of clinical documents, such as protocols, protocol amendments, IB and informed consent forms
- Proven track record showing excellent clinical project management skills
- 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)
- Ability to lead multi-disciplinary teams both internally & externally
- Must have demonstrated problem solving abilities, excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Ability to work independently and as part of a team
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- 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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