Internal Application: Senior Clinical Program Manager
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 Senior Clinical Program Manager (Senior CPM) 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
- Partners 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
- Oversees 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
- Collaborates with the DCO on the development of study specific plans and/or processes (e.g. study protocols, Case Report Forms, Informed Consent Forms, etc.)
- 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
- 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
- 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) and 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.
- 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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