Director, Clinical Operations (Contract)

South San Francisco, CA, United States
Oct 01, 2020
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Director, Clinical Operations (Contract)

The Director, Clinical Operations leads the planning, coordinating and execution of multiple clinical trials in accordance with project milestones, within budget and with high quality in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and Principia SOPs.

The Director is accountable for the study level execution of Clinical Operations early phase study deliverables. The Director will be responsible for leading the study execution for phase 1 clinical pharmacology and early phase trials, managing and identifying risks and risk mitigation strategies.

This position is located in South San Francisco, CA and reports to the Vice President Clinical Trial Management and Clinical Operations.

  • Direct clinical operations activities for phase 1 clinical pharmacology and early phase trials ensuring compliance with Good Clinical Practices (GCP), ICH and applicable regulations
  • Responsible for the oversight providing direction and oversight to CRO Study Teams. Will lead Study Execution to ensure protocol and regulatory compliance
  • Responsible for CRO selection and management, investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and for phase 1 clinical pharmacology and early phase trials
  • Develops project timelines, to meet department and corporate goals for timely initiation and completion of clinical studies
  • Identify study risks and develop and implement mitigation strategies for clinical studies
  • Oversee KPI tracking CRO for assigned trials, e.g., tracking of clinical reviews, data query resolution for therapeutic indication
  • Provide senior management with timely updates on progress and changes in scope and schedule
  • Coordinate and responsible for oversight of investigator meetings slides and content
  • Partner effectively with Clinical Pharmacology, Project Management and DMPK to ensure regular and effective communication with key stakeholders including, Regulatory Affairs (RA), Biostatistics, Data Management, Clinical Supply, Clinical Research, Legal, Finance, and others, as necessary.
  • Coordinate and contribute to clinical study reports, protocol writing and other clinical documents in conjunction with Medical Writing and clinical pharmacology.
  • Ensure Clinical Trial Master File for assigned trials are being updated by CRO and are inspection ready
  • Participate in and implementation of new SOPs and departmental processes.
  • Assess feasibility of enrollment across different indications by providing assessment of timelines/rate of patient availability.
  • Lead the development of and accountable for all study related plans necessary for trial conduct.
  • Mentor junior clinical operations team members.

  • Keeps abreast of current industry practices and standards for outsourcing and GCP system requirements
  • Self-directed and collaborative while building strong working relationships across multiple departments to finalize documents, including in high-pressure situations
  • Demonstrated knowledge of clinical regulatory documentation requirements (familiar with GCP, CTD, FDA, and ICH requirements).
  • Demonstrate ability to communicate and write clearly, concisely, and effectively with an aptitude for compilation, analysis, and presentation of data.
  • Excellent writing and editing skills with meticulous attention to detail with solid writing and organizational skills.
  • Ability to influence without management authority
  • Able to problem solve and use good judgement
  • Detail oriented
  • Strong program management and people management skills
  • Subject to COVID-related conditions and restrictions, must be willing to travel domestically and internationally

Preferred Education:

B.A. or advanced degree in biological science or life sciences discipline.

Preferred Experience:

At least 15 years' experience in clinical operations with 5 years' experience leading and managing the execution of clinical pharmacology and early phase clinical trials from start-up through clinical study report generation.

Preferred Computer Skills:

Thorough working knowledge of personal computer systems and desktop office applications, including proficiency in MS Word, Excel, and PowerPoint and Microsoft Project.

Principia Biopharma is an equal opportunity employer.