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Clinical Trial Manager
Emeryville, CA
Job Description
This position can be 100% remote.
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 Dusseldorf, Germany.
Under the direction of the Executive Director Clinical Operations, the Clinical Trial Manager (CTM) will be responsible for the oversight and execution of clinical studies according to SOPs, ICH/GCP guidelines and regional regulations. The CTM will also be responsible for 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.
The CTM will be responsible for the management and oversight of sponsored clinical trials in various therapeutic areas as determined by the needs of the organization. CTM responsibilities include overseeing CROs and ensuring compliance with all regulatory requirements and evaluating and selecting study investigators. The CTM will drive the selection and supervision of all vendors for the responsible study.
Responsibilities- Serve as primary clinical point of contact for external vendors, cross-functional team and serve as study lead.
- Liaise and oversee 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 study archive.
- Coordinate the execution of external vendor 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.
- Bachelor's degree in the science/health care or other relevant field; master's degree a plus.
- 6+ years of clinical development experience at a pharmaceutical/biotech or CRO required.
- 2+ years at the manager/trial or project manager level required.
- Experience conducting vaccine clinical trials a plus.
- Thorough understanding of FDA, ICH and GCP guidelines.
- Strong organizational, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment.
- Ability to lead, prioritize and handle multiple tasks to meet deadlines in a dynamic environment.
- Excellent written and oral communication skills, strong computer skills (Excel, Word, PowerPoint) and solid presentation skills.
- Travel may be required (up to 25%).
- 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.
The estimated salary range for this position is $136,000 to $151,000. Final pay determinations may depend on various factors, including, but not limited to experience level, education, geographical location, knowledge, skills, and abilities. The total compensation package for this position also includes other compensation elements such as stock equity awards and participation in our Company's discretionary annual bonus program. Dynavax also offers a full range of health and welfare insurance benefits, 401(k) company match, and paid time off benefits, including 17 paid holidays in 2024.
#LI-REMOTE
California residents: for information on how we handle your personal information and your privacy rights as a job candidate, please see our Candidate Privacy Notice:
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.
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. Dynavax complies with The Americans with Disabilities Act (ADA) and the Americans with Disabilities Amendments Act (ADAAA). If you have a disability and feel you may need an accommodation in connection with the on-line application process, please email us at HR@dynavax.com.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
6+ years
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