Vice President, Head of Clinical Operations

4 days ago

Fremont, California, United States Ray Therapeutics, Inc. Full time

Vice President, Head of Clinical Operations

Ray Therapeutics, Inc. is looking for Vice President, Head of Clinical Operations in Fremont, CA.

This local job opportunity with ID 3035417738 is live since 2025-01-14 16:42:59.

About Us

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 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.
  • Take lead on program level responsibilities, including budget forecasting and drug forecasting.
  • 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 experience is strongly desired.
  • Ophthalmology (retina) experience is desired.
  • Biotechnology experience is 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 healthcare benefits.

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