Job Title: Head of Clinical Affairs
Location: San Francisco
Type: Full-Time (on-site)
Coherence Neuro is a highly interdisciplinary neurotechnology company solving some of the most challenging biological and medical problems that remain unmet. Our goal is to develop technologies that significantly increase the quality and length of life for those with debilitating and deadly cancers in the brain and body. We are backed by the best global venture capital firms, and are scaling our team across multiple sites to bring our products to those who need it as quickly and safely as possible. If you're driven to push the boundaries of engineering and science and want to help build something that genuinely changes lives, we want to hear from you. We value diversity and encourage applicants from all backgrounds to join us in our mission. Learn about our team here!
We are building a robust clinical pipeline and looking for a detail-orientated and ambitious Head of Clinical Affairs who is passionate about building the early clinical strategy and putting it into action. The successful candidate will work closely with Translational Science, Data Science, Regulatory, Quality, surgical and clinical advisors, CROs and investigators. The ideal candidate will have prior experience leading multiple clinical trials from protocol development to study close out.
Key Responsibilities
- Establish the clinical development plan for FIH and early feasibility.
- Integrate existing preclinical, bench, risk-management and reimbursement strategy evidence into clinical protocols that inform therapy safety and efficacy.
- Own clinical content of the investigator's brochure, informed-consent materials, CRFs and clinical risk analysis.
- Partner with Data Science on statistical and neural-data analysis plans, data reviews and interpretation of results.
- Lead ongoing review of clinical, safety, laboratory and operational data to identify trends, risks and data-quality issues.
- Ensure sponsor obligations are met, including safety reporting, regulatory and ethics notifications, and sponsor files and the trial master file.
- Lead study start-up through close-out
- Set the CRO and vendor strategy, deciding what to keep in-house versus outsource, and lead vendor selection and oversight.
- Define clinical evidence requirements for regulatory/ethicssubmissions
- Lead clinical sections of regulatory submissions and pre-submission meetings
- Build relationships with key opinion leaders, hospitals and patient advocacy groups..
- Work with the CSO and surgical advisor to establish and run surgical, neuro-oncology and radio-oncology advisory boards.
- Lead investigator meetings, scientific training and responses to clinical questions from sites.