Clinical Trials Project Manager

Join a dynamic organization dedicated to advancing innovative solutions within the life sciences sector. This is your opportunity to contribute to cutting-edge clinical research that has the potential to transform patient outcomes and improve global health. As part of a passionate team, you will play a vital role in shaping the future of clinical development while developing your expertise in a collaborative, growth-focused environment.

Our client is a growing business specializing in clinical development and research support within the biotechnology and pharmaceutical industries. They focus on innovative therapies for metabolic, liver, kidney, and CNS diseases, offering significant opportunities for impact and career progression. The role of Clinical Trials Project Manager and Regulatory Assistant is central to their mission—driving the successful design, execution, and regulatory compliance of clinical studies that support the development of novel therapies.

In this role, you will be responsible for overseeing the planning, management, and execution of global clinical trials. Working closely with multidisciplinary teams, you will ensure study timelines, budgets, and quality standards are met, while maintaining regulatory compliance across regions. Your insights will contribute to strategic decision-making, scientific integrity, and successful regulatory interactions, ultimately accelerating the development of important medical breakthroughs.

Key Responsibilities:

• Lead the development and implementation of clinical trial strategies in collaboration with scientific and operational teams.
• Manage day-to-day clinical trial activities, including site selection, trial setup, and monitoring.
• Support regulatory submissions and ensure adherence to Good Clinical Practice (GCP) and relevant guidelines.
• Oversee data collection, review safety data, and communicate findings to stakeholders.
• Manage external vendors such as Contract Research Organizations (CROs) and oversee their performance.
• Mentor junior team members and contribute to process improvements within R&D and Clinical Development.
• Maintain effective communication with internal teams, investigators, regulatory authorities, and external partners.

Ideal Candidate:

• A relevant science degree (e.g., Master’s, PharmD, PhD) with 5-7 years of clinical research experience, ideally within biotech or pharma.
• Proven expertise in managing clinical trials, with experience supporting programs from early translational research to later-stage development.
• Knowledge of regulatory processes, including IND submissions and interactions with agencies such as the FDA.
• Excellent project management, communication, and team leadership skills.
• Familiarity with platform technologies like siRNA and ASO is a plus.
• Ability to work on-site in San Diego, CA, with an openness to travel up to 15% internationally.

This role offers a competitive base salary ranging from $130,000 to $180,000, depending on experience, along with a comprehensive benefits package including health insurance, 401(k), paid time off, and more.

Apply now to be part of a growing team shaping the future of innovative therapies in life sciences.

Please note: When you apply, a real person from our team will review your details and reach out. We are committed to transparency, fairness, and building meaningful human connections.