Chief Clinical Strategy & Trials Lead

Opto Biosystems; San Francisco (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Coherence Neuro is seeking a Head of Clinical Affairs to lead the early clinical strategy for our neurotechnology programs in a San Francisco on-site role. The candidate will collaborate with Translational Science, Data Science, Regulatory, Quality, and surgical/clinical advisors, CROs and investigators to drive trial conduct from protocol through close-out.

The ideal candidate has a track record of leading multiple trials and coordinating cross-functional teams to meet regulatory and ethical

Qualifications

• Experience leading multiple clinical trials from protocol development to study close-out.
• Strong collaboration with Translational Science, Regulatory, Quality, CROs and investigators.
• Ability to define clinical evidence requirements for regulatory submissions.

Responsibilities

• Establish the clinical development plan for FIH and early feasibility.
• Integrate preclinical and reimbursement evidence into clinical protocols for safety and efficacy.
• Own clinical content of the investigator's brochure, informed-consent materials, CRFs and risk analyses.
• Partner with Data Science on statistical plans and data interpretation.
• Lead ongoing review of clinical and safety data to identify trends and quality issues.
• Ensure sponsor obligations are met, including safety reporting and ethics notifications.
• Lead study start-up through close-out and vendor oversight.

Skills

Clinical trial leadership

Regulatory coordination

Stakeholder management

Data analysis collaboration

Job description

Coherence Neuro is seeking a Head of Clinical Affairs to lead the early clinical strategy for our neurotechnology programs in a San Francisco on-site role. The candidate will collaborate with Translational Science, Data Science, Regulatory, Quality, and surgical/clinical advisors, CROs and investigators to drive trial conduct from protocol through close-out.

The ideal candidate has a track record of leading multiple trials and coordinating cross-functional teams to meet regulatory and ethical