Senior Clinical Trial Manager
Clinical Operations | South San Francisco, CA | Full Time
Tolerion is a clinical-stage biopharmaceutical company founded upon breakthrough discoveries in immune modulation by Larry Steinman and colleagues at Stanford. We have an extensive product portfolio that stems from pursuing our core competencies in immunology and molecular biology. Our first three named product candidates, one in late stage clinical trials, address autoimmune disorders with candidates invented using our proprietary antigen-specific immune tolerance induction platform. Our fourth program, a monoclonal antibody for treatment of ALS, inhibits a novel integrin target discovered by Larry Steinman and leverages his lifetime of work in integrin biology, including his role in the discovery and development of integrin inhibitor, Tysabri®.
We engineer product candidates that restore balance in autoimmune conditions in which self-antigens (or “autoantigens”) incite a destructive immune response. This approach has the important benefits of targeting the root of the pathogenic immune response without impairing healthy immune function more broadly. This affords significant efficacy and safety advantages relative to other approaches in development. This approach has been validated in human clinical trials with two platform products. Both products showed positive changes in markers of immune response and correlative changes in clinical efficacy endpoints.
Our most advanced program, TOL-3021, has promising safety and efficacy data from a completed Phase 2 study in patients with established type 1 diabetes. We have initiated a larger-scale, registration grade study in adults with established disease and have authorization to proceed into pivotal studies in both established and new onset T1D. TOL-3034 and TOL-3052 are our clinical development candidates to treat myasthenia gravis and neuromyelitis optica, respectively – two orphan diseases with very well-established causal autoantigens. Having established GMP manufacturing processes for our lead program, we are ready now to initiate CMC development activities on our remaining platform products to support first-in-human clinical studies with proof-of-activity endpoints. We own all rights to our products in development.
The Senior Clinical Trial Manager will assist in the day-to-day operational and logistical aspects of clinical trial operations according to ICH-GCP and internal company procedures. Reporting to the Director of Clinical Operations, (DCO) this position will support the clinical project team, ensuring that all essential clinical documentation is collected, maintained and filed during the study and perform monitoring when needed.
- Performs job duties with appropriate guidance.
- Collaborate with DCO and/or CRO to set targets for clinical monitoring staff and ensuring recording of trial in compliance with project goals
- Creating and implementing study-specific clinical monitoring tools and documents
- Creating and overseeing trial budget
- Assist DCO and/or CRO with identifying, enlisting and choosing sites and coordinating site management activities
- As necessary and applicable, providing Clinical Research Associates with project-specific training and having regular meetings with them
- Documenting and sharing interactions with sites, CRO and other Agencies
- Assisting with and/or arranging and overseeing site visits
- Partner with the DCO in providing oversight of contract research organizations, vendors and other suppliers of project services to ensure study deliverables are met during start-up, conduct, and close-out activities
- Oversee clinical site performance to ensure that study enrollment and GCP data collection are on track. Identify and implement corrective actions as necessary to complete the study on time and on budget
- Reviews documents for completeness, accuracy and compliance with protocol and appropriate regulations, identifies issues and takes appropriate corrective action as necessary
- Collects and reviews regulatory documents from clinical sites as needed
- Performs monitoring and co-monitoring at selected clinical sites when needed
- Work closely with other teams in the organization
- Willingness to travel to clinical sites, investigator meetings, medical conferences and otherwise as required from time to time
- Ability to write and review technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
- Assuring compliance SOPs and local regulations, and CFR, ICH and GCP guidelines
- Other duties as assigned
Requirements & Experience:
- Bachelors or Masters Degree in Nursing, life science, or related field (or equivalent experience) with at least 8 years of relevant clinical operation experience as CRA or study associate for clinical studies
- 3+ years work experience for a pharmaceutical or biotechnology company
- Prior experience in clinical trials (e.g. clinical trial design, execution and operations) and understanding of clinical study operations
- Experience working successfully with vendors, e.g. CRO, Laboratory & Clinical supply vendors). Thorough knowledge of Good Clinical Practices
- Detail and team oriented with excellent cross-functional team leadership and participation skills.
- Desire to learn and tackle new challenges is imperative
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced, small company environment that requires flexibility to adjusting workloads based upon changing priorities and willingness to be a team player in order to accomplish the common goal of the project, regardless of level or type of work
- Proficient with Microsoft Office Word and Excel
- Understanding of Electronic Data Capture (EDC)
- 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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