Senior Manager - Clinical Compliance

February 5

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $125 / hour

⏳ Contract/Temporary

🟠 Senior

🚔 Compliance

Apply Now

Receive Emails with Similar Jobs

Dynavax Technologies

WebsiteLinkedInAll Job Openings

Dynavax Technologies is a commercial-stage biopharmaceutical company focused on developing and commercializing novel vaccines to combat infectious diseases. The company utilizes proven and innovative adjuvant technology, such as its CpG 1018® adjuvant, to enhance the effectiveness of vaccines, including its HEPLISAV-B® product. With a commitment to making a global impact on public health, Dynavax actively engages in clinical trials and values driven team collaborations to advance its pipeline of vaccine solutions.

Infectious Diseases, Biodefense, Vaccine Manufacturing and Vaccines

201 - 500 employees

Founded 1996

🧬 Biotechnology

💊 Pharmaceuticals

💰 $200M Post-IPO Debt on 2021-05

📋 Description

• 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. • 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.

🎯 Requirements

• 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.