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Neuron23 Inc. is a clinical-stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases. Neuron23 leverages recent advances in human genetics combined with drug development powered by advanced Data Science and biomarker platforms to advance therapeutics for devastating diseases. For more information about Neuron23 please visit www.neuron23.com(link removed)>

The Sr. Clinical Trial Manager/Associate Director Clinical Operations, manages the overall operation of the clinical studies including project planning, budget, resource management, contract research organization, and vendor management. This role manages the clinical operational plan and incorporates the study and scientific plans. They will develop study related documents and overall direction for the clinical sites to establish protocol adherence, and ensure compliance with good clinical practices, good manufacturing practices and regulatory guidelines. This person will be enabled to recommend and implement innovative process ideas to impact clinical trial management. They will develop and manage clinical budgets and develop contingency plans for clinical trials.

The successful candidate has the combination of a deep understanding of the tools and techniques of clinical trial operation as well as the ability to contribute to clinical trial design and planning. The individual must also have the skills and experience to manage external partners and providers, which are critical to the companys execution of trials. Outstanding candidates are those that demonstrate creative thinking and have a track record of innovation in clinical trial execution, such as in site selection and patient enrollment.

Principal Accountabilities

• Supervise the services provided by contracted clinical research organizations, clinical laboratory vendors, and other outsourced partners in order to ensure expectations are met and budgets are within guidelines.
• Create, review, and implement clinical study documents (protocols, informed consent forms, clinical study plans, Case Report Forms, etc.).
• Drive IRB/ethics committee and regulatory submissions as needed to meet study timelines.
• Evaluate qualified study sites, oversee site initiation, plan and present at investigator meetings/advisory boards, and implement study start up activities including development of documents related to conduct of the study in collaboration with the clinical study team.
• Lead the set up and management of the Trial Master File (TMF).
• Determine drug requirements for studies, coordinate the distribution of clinical lab samples to central/niche laboratories, and specify shipment logistics to ensure on-time supply for trials.
• Periodically review clinical data, quality metrics and study deviations in order to ensure trial performance measures are being met and the early identification and resolution of issues.
• Manage the deployment of other resources to ensure timelines are met.
• Systematically update Neuron23s senior management on the status of studies to ensure timely problem-solving and to proactively identify and mitigate risks.

This is a full-time position is based in the San Francisco Bay Area and there is a preference for candidates who can work in the office at least three days per week while working-from-home on other days (i.e., a hybrid model). Travel will be required to domestic and international development partners, CROs, vendors, and clinical sites, as needed. The estimated salary range is $175,000 - $190,000. Salary determinations are based on various factors, including but not limited to the level and scope of job responsibilities. Individual pay is further determined by relevant work experience, education, training, skills, certifications and location.

Requirements

• Comprehensive understanding of the overall drug development process typically achieved through a Bachelors degree in a scientific discipline and 8 years of clinical trial experience in a pharmaceutical, biotech, or a CRO. Advanced degree and multiple years of experience in neurological disorders and/or immunology are differentiators among candidates.
• Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations.
• Excellent time management skills with the ability to prioritize deadlines and multitask.
• Self-starter with a demonstrated ability to work in collaboration and cooperation with members of a multidisciplinary team.
• Team player with ability to motivate and influence cross-functional team members.
• Ability to handle multiple projects simultaneously, communicate clearly and effectively, and build collaborative relationships.

• Ability to thrive in a fast-paced, entrepreneurial environment, working collaboratively as well as independently, under broad strategic guidance.
• Verbal and written communication skills to the level of effectively producing and delivering compelling and insightful presentations to diverse audiences.

Benefits

Neuron23 offers a comprehensive and competitive benefits package to help our employees and their family achieve their physical, financial, emotional, and social wellbeing goals.

Neuron23 is proud to be an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

Neuron23 requires employees to be vaccinated against COVID-19. If there is a medical condition or religious belief that prevents an employee from being vaccinated we will consider whether Neuron23 can make a reasonable accommodation.