Director of Scientific Affairs
Atreca is a biotechnology company focused on applying its Immune Repertoire Capture™ technology to discover and develop novel cancer immunotherapeutics. Located in Redwood City, California, Atreca is looking for talented, entrepreneurial people who are dedicated to making a positive impact on human health. We have a unique opportunity for a highly motivated individual to become a key member of our growing biotechnology company.
We are looking for an outstanding Director of Scientific Affairs who will apply their experience and expertise in drug development and technical writing skills to prepare regulatory filings as well as supporting scientific reports.
- Author, revise, and review internal scientific documents supporting a variety of projects including IND submissions, BoD presentations and internal and external communications.
- Ensure accuracy and relevance of reports and presentations in various formats
- Prepare and edit executive summary documents and briefings
- Draft and edit up to date scientific presentations with colleagues in research
- Develop and maintain other technical documentation required for compliance such as policies, SOPs, regulatory content for design history files
- Edit complex and lengthy technical documents for clarity, grammar, spelling, punctuation and consistency
- Participate in proactive and continuous improvements for Regulatory Affairs and in support of the quality system
- Perform data analysis as needed and develop related graphics and figures.
- Interact with internal stakeholders and with external service providers to ensure the timely development, review, and publication of reports.
- Work with third parties including CROs, key opinion leaders, consultants and contractors during development of technical documents.
- Responsible for creation of additional output as needed to support executive team
- Doctorate degree in a life science required.
- Minimum of 10 years of experience in the biotechnology/pharmaceutical industry is required
- Previous experience preparing regulatory documents, scientific protocols and reports, design history file content, and SOPs
- Understanding of design control procedures
- Expert level use of Word and PowerPoint and experience with document management systems (SharePoint) and document sharing systems
- Strong analytical skills
- Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation, and style
- Ability to prioritize and multi-task while maintaining a positive and collaborative attitude
- Ability to communicate clearly and professionally, both orally and in writing
- Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders
- Flexibility to support changing assignments and priorities in an independent and reliable manner