Ray Therapeutics (RayTx) is a clinical-stage biotechnology company pioneering optogenetic gene therapies for blinding retinal diseases. RayTx aims to provide best-in-class and first-in-class, mutation-agnostic, vision restoration to patients without available treatment options. Founded in 2021 and headquartered in Berkeley, CA, the company raised $100 million in a Series A financing led by Novo Holdings in May 2023.
RayTx's lead asset, RTx-015, delivers a highly bioengineered light-sensitive protein, and is currently in phase 1/2 clinical trials, initially for retinitis pigmentosa (RP). RayTx's second asset, RTx-021, is expected to enter clinical trials in 2025 for Stargardt macular dystrophy (STGD) and geographic atrophy age related macular degeneration (GA AMD).
For additional information, please visit www.raytherapeutics.com.
Position Summary
The Head of Clinical Operations is a crucial leadership role responsible for overseeing and directing all aspects of clinical operation and must balance strategic vision with hands-on operational management to drive the organization's clinical research initiatives forward.
This role is critical in ensuring the successful execution of clinical trials, advancing drug development efforts, and ultimately contributing to improved patient outcomes.
This position requires a combination of strategic vision, operational expertise, and clinical knowledge.
The successful applicant will report to the Chief Medical Officer.
The role is based in our Berkeley, CA office with a hybrid work from home/in office requirement and will require travel to our clinical trial sites, efficacy testing facilities, conferences and other travel, as required.
Key Responsibilities
Strategic Leadership
Develop and implement the company's clinical operations strategy, aligning it with overall business objectives
Provide strategic and operational leadership for clinical studies, ensuring compliance with all regulatory guidelines
Lead and build a team of Clinical Operations professionals, as determined, to oversee the implementation and execution of all sponsored clinical trials
Operational Management
Oversee the planning, execution, and reporting of all phases of our clinical trials (US and global)
Monitor overall operations of clinical facilities, ensuring staff efficiency and high-quality patient care
Develop and implement clinical protocols, policies, and procedures to enhance patient care experience and safety
Financial Oversight
Take lead on program level responsibilities, including budget forecasting and drug forecasting
Team Leadership
Serve as the senior operational contact for studies and lead cross-functional teams, including both internal and external resources
Hire, train, and direct staff, demonstrating strong leadership skills
Regulatory Compliance
Ensure all clinical operations adhere to regulatory guidelines and Good Clinical Practice (GCP) standards
Qualifications
Education
Bachelor's degree, plus advanced degree in a relevant field, such as an MSN (Master of Science in Nursing) with a clinical background, or equivalent clinical certification
Experience
15+ years experience in clinical operations
Proven track record in leadership roles within clinical research or healthcare settings
AAV gene therapy, strongly desired)
Ophthalmology (retina), desired
Biotechnology experience, essential
Skills
Strong leadership and management abilities
Excellent communication and interpersonal skills
Proficiency in operations management and organizational skills
In-depth knowledge of clinical development processes and clinical trials
Analytical and problem-solving skills
Familiarity with regulatory requirements and industry standards
Key Attributes
Strategic thinker with the ability to drive innovation in clinical operations
Results-oriented with a focus on efficiency and quality in patient care
Adaptable and capable of managing multiple projects simultaneously
Collaborative leader who can work effectively with cross-functional teams and external partners
Working Conditions
Prolonged periods of being at a stationary desk or work computer
Ability to occasionally adjust, handle, or move objects up to 20 pounds
Ability to assess the accuracy, neatness, and/or thoroughness of the work assigned
Travel up to 25% within the United States
Ray Therapeutics does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
Ray Therapeutics offers a competitive total rewards package that includes a market competitive base salary, target bonus, and equity in addition to health care benefits.