Vice President, Clinical Operations - Berkeley, CA (Hybrid) in Berkeley, California at RAY THERAPEUTICS INC

Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.

We are currently seeking a visionary, high-impact leader to serve as Vice President (VP), Clinical Operations. Reporting directly to the Chief Medical Officer, you will serve as the operational architect of our global clinical pipeline. In this key leadership role, you will hold ultimate accountability for overseeing all clinical trials, optimizing budgets, and steering complex development timelines. You will lead, mentor, and scale a world-class team of clinical professionals, fostering a culture of operational excellence. Operating at the critical intersection of science, business strategy, and patient advocacy, you will ensure every trial meets the highest standards of global regulatory compliance while rapidly advancing life-changing therapies to the patients who need them most.

In this role, you will:

• Provide operational direction for outsourcing, selection, and oversight of CROs and provide ongoing executive management to selected partners.
• Develop and continuously monitor study timelines, study progress, study costs, and resource allocations. Implement corrective action when deviations occur; work with functions to develop contingency plans and drive their implementation when triggered.
• Oversee the preparation and management of clinical trial budgets. Support Finance and Corporate Development to forecast estimated costs for potential studies. Liaison with Clinical and Finance teams to review CRO budgets, change orders, invoices, and to approve payments.
• Serve as the Clinical Operations leader for internal governance meetings including cross-functional Project Team and Protocol Review Committee; effectively communicate clinical execution milestones, risks and strategic pivots.
• Interact collaboratively with Quality, Regulatory, CMC, Finance, and Clinical teams to ensure operational excellence in clinical trial execution to ensure compliance with GCP and ICH guidelines and financial reporting requirements.
• Support development of SOPs and establishment of associated training for teams and ensure operational excellence in clinical trial execution to ensure compliance with GCP and ICH guidelines and financial reporting requirements.
• Collaborate with internal team members to ensure compliance with all domestic and foreign regulatory requirements governing the conduct of clinical trials.
• Lead long-range workforce planning, forecasting future hiring needs to scale the clinical operations team effectively as the pipeline expands.
• Lead, mentor, and develop a high-performing team focusing on professional growth, coaching, and succession planning.

Your qualifications and skills include:

• Bachelors degree within a scientific discipline; advanced degree (MS/RN/PharmD) preferred.
• 15+ years’ experience in Clinical Operations; with at least 5 years in biotechnology preferred. Strong preference for experience in AAV gene therapy and/or Ophthalmology (retina).
• You possess an expert level of knowledge within clinical operations, clinical development, and clinical project management.
• You have demonstrated success in leading clinical operation teams for early and late-stage clinical development programs.
• In depth knowledge of all aspects of CRO management and clinical trial audit activities.
• Demonstrated ability to effectively communicate clinical execution milestones, risks, and strategic pivots.
• Demonstrated ability to cultivate a mission-driven culture of high accountability, scientific integrity, and patient-centricity, ensuring that organizational values are deeply embedded across internal teams and external vendor partnerships.
• Ability to work from our Berkeley, CA office 3 days per week.

Compensation Range and Benefits:

• For this role, the anticipated base salary range: $345,000 to $365,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
• Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.

At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.

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