Senior Manager, Clinical Compliance (Contractor)

This position can be 100% remote, but must be located in the United States.

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the world against infectious diseases. We operate with the highest level of quality, integrity and safety for the betterment of public health. Our proprietary CpG 1018 adjuvant powers our diversified infectious vaccine portfolio, which includes HEPLISAV-B®, our commercial product approved in the U.S. and the European Union, for prevention of hepatitis B virus in adults. We also supply CpG 1018 to research collaborations and partnerships globally. Currently, CpG 1018 is being used in development of COVID-19, plague, shingles, and Tdap vaccines.

At Dynavax, our vision and work ethic are guided by the collective ideals underpinning our core values, and these form the basis of our dynamic company culture. We strive to maintain a culture where each employee is valued by the organization and where our organization is valued by each employee. We offer a highly flexible work environment for our headquarter employees where individuals work remotely and gather for in-person meetings when necessary.  Dynavax is headquartered in the San Francisco Bay area, and our manufacturing facility is in Düsseldorf, Germany.

The Senior Manager, Clinical Compliance (MCC) will provide oversight of clinical trial and compliance activities and drive continuous process improvement within Clinical Development. The MCC will ensure clinical studies are conducted in compliance with Good Clinical Practice (GCP), government regulations, SOPs and overall clinical objectives and may assist with other clinical study activities as needed.

• Support investigations, effectiveness checks and assist with managing Clinical Quality Events (non-conformances, deviations, quality issue trends).
• Help conduct root cause analysis.
• Advise on preparation for audits and coordination and completion of corrective actions from audits and inspections of clinical studies.
• Coordinate document/form completion, revisions and submissions to GCP/PVG Quality & Compliance Department and facilitate document drafting and review to applicable Clinical Operations team members.
• Develop and/or maintain Clinical SOPs including revisions and periodic (biennial) reviews.
• Respond to common clinical process inquiries from internal and external team members.
• Proactively identify gaps, inform of potential problems or opportunities to improve the Clinical processes and work to implement process improvement, address and resolve issues and gaps; escalate as appropriate.
• Partner with the GCP/PVG Quality & Compliance Department; act as lead Clinical Operations contact when applicable.
• May work with CRAs on monitoring oversight and perform oversight visits.
• Support Clinical Project Managers with oversight of study CROs and other external vendors to facilitate their ability to complete trials within timelines and quality as required. 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 and compliant study execution.
• Occasional travel may be required, up to 25%.
• Other duties as assigned.

• BA/BS in Life Sciences or equivalent; Master’s degree preferred.
• 7 years clinical research and clinical project management related experience.
• 1 year of clinical operations compliance experience.
• Expert knowledge of ICH-GCP and FDA regulations.
• Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and site management/monitoring.
• Extensive experience with effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques.
• Ability to perform detail-oriented work on multiple projects with a high degree of accuracy under minimal supervision and aggressive timelines.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, etc.), Adobe and eTMF systems.
• Robust organizational, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment.
• Ability to sit; stand; walk; reach with arms and hands; lift and move small objects; and use hands to keyboard and perform other office related tasks including repetitive movement of the wrists, hands and/or fingers.

• This is a contract position that requires up to 40 hours per week.

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Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

Salary : $125