Sutro Biopharma - San Francisco, CA

posted 21 days ago

Full-time - Senior
San Francisco, CA
Professional, Scientific, and Technical Services

About the position

The Vice President, Clinical Operations at Sutro Biopharma is responsible for overseeing all clinical operational activities, ensuring alignment with organizational objectives, and managing the execution of clinical trials. This role involves strategic leadership, cross-functional collaboration, and accountability for delivering high-quality clinical study data on time and within budget, while adhering to regulatory requirements and internal SOPs.

Responsibilities

  • Lead Clinical Operations Teams to expedite execution of clinical trials, including participating in the design, implementation, and review of clinical protocols and study reports.
  • Acquire and sustain advanced knowledge of the therapeutic area and product and clinical trial setting.
  • Manage and mentor team members, ensuring role training is completed and current.
  • Establish strong interactions with cross-functional partners and serve as the escalation point of contact.
  • Ensure timely delivery of high-quality clinical study data and collaborate to present results to senior management and external stakeholders.
  • Identify, qualify, manage, and maintain relations with clinical trial sites, collaborating with Principal Investigators and CROs.
  • Lead or assist in writing, reviewing, and approving clinical project deliverables.
  • Participate in the selection process of CROs and vendors.
  • Assist with strategic planning for site/country selection and contract negotiations.
  • Develop study presentations and coordinate Investigator Meetings and Advisory Boards.
  • Ensure all studies are conducted ethically and in compliance with GCP and regulatory policies.
  • Collaborate with Clinical Development and Finance to manage the annual budget for clinical activities.
  • Review contracts and work closely with the Legal department.

Requirements

  • University/college degree in health care or other scientifically related discipline is required; an advanced degree (e.g., Masters, MBA, MD, PhD) is preferred.
  • 10 or more years of experience in a leadership function in clinical operations with a proven track record of people and project management.
  • Strong background in drug development and working knowledge of various functional areas.
  • Excellent understanding of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
  • Ability to interact cross-functionally at all levels within the company and externally with consultants, contractors, and investigators.
  • Strong organizational skills and the ability to prioritize and multi-task.

Nice-to-haves

  • Experience in a scientific discipline with clinical drug development experience in the pharmaceutical or biotech industries is preferred.

Benefits

  • Competitive salary range of $350,000 - $380,000 (not including bonus, equity, and benefits).
  • Opportunities for professional development and growth within the company.
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