JOIN OUR TEAM.

At Regulus, we have fostered a culture that values scientific rigor, creative problem solving, collaboration across departments and disciplines, and persistence in the face of obstacles.

Above all else, we are inspired by the many individuals worldwide affected by genetic kidney diseases and other genetically-based, orphan diseases.

Located in San Diego, California, we are a dedicated team of scientists, researchers, and biotech professionals committed to learning and growth, and to the patients we serve.

Current Openings.

Clinical Trial Manager

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Position description and scope:

The successful candidate will join the Clinical Operations Team, focusing on maintaining quality in various clinical operations activities. These activities include clinical monitoring and co-monitoring, managing sites and supplies, generating reports, reviewing data, and managing the trial master file. The Clinical Trial Manager will ensure that all study deliverables meet quality standards and comply with SOPs, GCPs, and ICH guidelines.

Job responsibilities:

  • Manage clinical aspects of Regulus’ trials under the oversight of Clinical Operations senior management.
  • Collaborate with cross-functional teams, CROs, and vendors to proactively manage trial execution.
  • Identify prospective issues that could interfere with meeting project goals and recommend solutions.
  • Partner with Regulatory and Quality functional areas to ensure compliance with regulatory agencies, ICH, and GCP guidelines.
  • Review CRO monitoring reports and provide mentorship for follow-up, issue resolution, and closure of action items.
  • Prepare, review, and assist in training and compliance with clinical trial manuals, documents, procedures, and systems, including but not limited to study-specific plans, CRF completion guidelines, and laboratory and imaging manuals.
  • Ensure clinical trial documents are filed, maintained, and archived in an audit-ready and due diligence-ready condition.

Minimum Qualifications:

  • Bachelor’s degree in a relevant scientific discipline or equivalent experience.
  • Excellent working knowledge of Good Clinical Practices; ICH guidelines; trial management practices and procedures.
  • 3 years’ experience as a clinical research associate with clinical monitoring experience in the biotechnology/pharmaceutical or CRO industry.
  • 1 year experience in clinical trial management
  • Proficient with Microsoft Office systems and electronic data capture applications
  • Excellent leadership, interpersonal and communication skills. Works efficiently with others to accomplish goals and resolve problems.  Encourages cooperation, collaboration, and co-ownership of processes.  Innovative problem solver.

Preferred Qualifications:

  • Experience with Global studies.

Benefits:

  • Option for fully remote or hybrid from the San Diego office.
  • The expected hiring range for this multi-level position is $110,000-$140,000 per year, commensurate with educational level, experience, and geographical location.
  • Generous annual bonus program and company stock options
  • Access to 401k plan with generous employer match.
  • Full suite of health plans including medical plan options, dental, vision, life insurance, disability, EAP and more.
  • Access to Flexible Spending Accounts.
  • Generous vacation, paid holiday, and sick leave policies.

You can visit our website to find out more about our company and culture: www.RegulusRx.com.

Regulus Therapeutics Inc. is proud to be an EEO Employer.

For immediate consideration, please apply to careers@regulusrx.com.

NO PHONE CALLS PLEASE. PRINCIPALS ONLY

General Application

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We’re always looking for talented individuals who are excited about our work. We’d love to hear from you at careers@regulusrx.com.

Benefits.

Regulus provides a competitive benefits package that includes a choice of health, vision, and dental insurance, life insurance, flexible spending accounts, 401K plan, vacation and stock options.

We believe that you, as an employee, matter above everything else. We back that statement up continuously with a unique approach to providing you with great benefits and valuable resources. Our benefits packages and resources are designed to support you in creating the life and work style that brings your best to your community, your family and Regulus’ mission of addressing significant unmet medical needs.

Most of our benefits cover employees who work at least 30 hours a week and their eligible dependents. Eligible dependents include:

  • A spouse or domestic partner
  • Children (biological, step, foster, adopted or legal charge) up to age 26
  • The majority of our benefits become effective immediately on the date of hire without any pre-existing condition exclusion (temporary employees, contractors, interns and co-ops are not eligible for benefits).

In addition to an array of health and financial benefits and learning opportunities, we offer competitive compensation and bonus programs that reward you for your contributions toward achieving the company’s mission and strategic goals. We also provide you with a wide range of services designed to help make life easier while you are at work, so you can spend your free time doing more of the things you enjoy most.