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Clinical Project Manager

Clinical

US-CA-Emeryville

Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.

Under the direction of the Sr. Director Clinical Operations, the Clinical Project Manager will be responsible for the oversight and execution of clinical studies according to SOPs, ICH/GCP guidelines and regional regulations. Overall management of Dynavax-sponsored clinical trials from study design to clinical report finalization, ensuring that the studies are conducted to the highest quality standards, are within the agreed budget and are delivered on time.

Management and oversight of sponsored clinical trials in various therapeutic areas as determined by the needs of the organization. To include overseeing CROs and to ensure compliance with all regulatory requirements for the study and evaluating and selecting study investigators. To participate in the selection of all vendors for the responsible study and their supervision. To serve as primary clinical point of contact for cross-functional team members and serve as study team lead. To manage timelines from project concept to delivery of the Clinical Study Report and study closure.

Responsibilities

  • Liaison and oversight with CROs and other external vendors to facilitate their ability to complete trials within timelines and to the required quality. This includes training key external staff on trial requirements throughout the trial duration.
  • Develop productive working relationships with internal colleagues, investigational site staff and CRO/vendor personnel to ensure high quality reporting throughout all study teams.
  • Work closely with internal key stakeholders to ensure successful design, implementation and oversight of clinical trials.
  • Lead cross-functional team meetings and mentor junior team members.
  • Lead the development and finalization of all study related plans (Clinical Monitoring Plan, Pharmacy Manual, etc).
  • Actively participate in the development of study-specific Trial Master File (TMF) plans and functional area QC reviews of the TMF.
  • Ensure excellent communication flow between the CRO, vendors and the Dynavax internal team.
  • Define and manage project risks, establishing key risks and managing those from the point of protocol development through to study archive.
  • Participate in the evaluation and selection of CROs and required external vendors (e.g. contract labs, IRT provider).
  • Coordinate the establishment of service provider contracts.
  • Ensure appropriate training is provided for the internal teams to conduct the trials.
  • Provide regular status reports to management and project team.
  • Perform study risk management and implement mitigations.
  • Identify potential study issues and recommend and implement solutions or corrective actions as needed.
  • Create realistic plans that clearly define goals, milestones, responsibilities, and results.
  • Maintain focus on strategic objectives while accomplishing operational goals.

Qualifications

  • A bachelor/master’s degree in the science/health care or other relevant field
  • 6+ years of clinical development experience at a pharmaceutical/biotech or CRO required
  • At least 2 years at the manager/project manager level
  • Experience conducting vaccine clinical trials a plus