Director, Clinical Operations

Clinical Development San Diego, California


Description

Director, Clinical Operations - San Diego, California

 

We’re a different kind of biotech company.  And we’re here to make a difference.

Prometheus Biosciences, Inc. (Nasdaq: RXDX), is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD).

The Company’s precision medicine platform, Prometheus360™, combines proprietary bioinformatics discovery methods with one of the world’s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets. Prometheus is headquartered in San Diego, CA.

Summary

Responsible for executing clinical strategies and ensure clinical trials are conducted efficiently to agreed corporate timelines and follow local and global requirements.

Key Duties and Responsibilities

  • Implement clinical development plans in order to meet corporate goals and objectives
  • Work cross functionally with other departments and functions to implement clinical trial protocols
  • Participate and assist in design and preparation of protocols and case report forms
  • Generate clinical SOPs, policies, charters and plans according to U.S. and international guidelines
  • Evaluate potential clinical contract research organizations (CROs) and sites according to established criteria of acceptability
  • Responsible for procurement of budgets, contracts, regulatory documents and other administrative documents as related to clinical research functions
  • Oversee CROs, clinical vendors and consultants
  • Manage activities of clinical operations staff
  • Prepare clinical documents for regulatory submissions
  • Attend scientific and external training meetings as needed
  • Willingness to travel, up to 25%, depending on business needs
  • Mentor and may supervise clinical operations staff, including CRAs and CTAs

Education and Experience

  • Bachelor’s degree, RN, BSN, Health or Science related degree or equivalent
  • 8 or more years experience in study management at a sponsor biotechnology/pharmaceutical company
  • Thorough knowledge and adherence to Good Clinical Practices (GCPs), clinical trials management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance, auditing including broad application of knowledge in different therapeutic areas, as well as standards outside the U.S.
  • Prior experience conducting large, global Phase II and III studies and understands operational pathway of working outside the U.S.
  • Experience with vendor management of CROs and contracted third party vendors managing a global program
  • Has a holistic understanding of Clinical Operations including experience reviewing proposals, reviewing start up documents; understands how to write and update protocols and interpret study budgets 

Essential Skills and Abilities

  • Unquestionable integrity, be able to inspire trust and exhibit the highest ethical standards
  • Excellent communication, verbal and written, and interpersonal skills with strong ability to interact with internal teams and partners across all levels of the organization
  • Ability to effectively present information and respond to questions from all levels of the organization
  • Sense of urgency, flawless execution with intense focus on accuracy and accountability
  • Self-starter, highly motivated, assertive, driven and hands-on leader
  • Ability to multi-task in a fast-paced, entrepreneurial, smaller company environment
  • Operate collaboratively with colleagues across functional areas in a science-driven environment
  • Ability to forge solid personal and professional relationships with key opinion leaders and investigators
  • Ability to work well under pressure and meet time sensitive deadlines
  • Ability to work across locations and time zones
  • Travel up to 25% may be required to meet with vendors, regulators and audits

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.