This work will have a particular focus on cGXP documents, IND-related workflows, and regulatory submission processes.
Key Responsibilities
- Design and build SharePoint program management landing pages that surface program documentation, risk communications, and action items for cross-functional stakeholders
- Integrate Smartsheet outputs or data feeds into SharePoint splash pages to support real-time, redundant visibility into program risks and actions
- Configure document control workflows using SharePoint and Power Automate, including assignment of document authors, reviewers, and adjudicators for IND-related regulatory submissions
- Build automated review and adjudication routing for IND chapter documents (e.g., modules submitted to FDA or ex-US health authorities), replacing manual email-based review chains
- Configure access controls and library permission structures appropriate for a regulated drug development environment
- Provide SharePoint site administration support — including troubleshooting and user access management — on an as-needed basis throughout the engagement
- Lead knowledge transfer and handoff to internal stakeholders upon project completion
- Optionally: assess and recommend opportunities to incorporate Microsoft 365 Copilot or SharePoint AI agent features
Skills Knowledge and Expertise
- Demonstrated experience designing and building SharePoint sites for program management use cases, ideally in a biotech, pharma, or regulated health sciences environment
- Proficiency in Power Automate workflow configuration within SharePoint
- Hands-on experience with document control systems and regulated document lifecycle management, including IND authoring pipelines or FDA submission workflows
- Working knowledge of SharePoint access controls, library permissions, and compliance-aware configuration
- Experience in clinical or drug development operational settings strongly preferred
- Ability to work independently, manage deliverables across a remote engagement, and communicate clearly with non-technical stakeholders
- A collaborative, solution-oriented approach and comfort operating in a fast-moving startup environment
- Must be based in the United States
About
BigHat Biosciences designs safer, more effective biologic therapies for patients using machine learning and synthetic biology. BigHat integrates a wet lab for high-speed characterization with machine learning technologies to guide the search for better antibodies. We apply these design capabilities to develop new generations of safer and more effective treatments for patients suffering from today’s most challenging diseases.BigHat is a Series B biotech outside San Francisco with a team-oriented, inclusive, and family-friendly culture. Our broad pipeline of wholly-owned and partnered therapeutic programs span many disparate indications with high unmet need, such as cancer, inflammation, and infectious disease. BigHat has raised >$100M from top investors, including Section 32, a16z, and 8VC.
Skills Required
- Demonstrated experience designing and building SharePoint sites for program management use cases (ideally biotech/pharma/regulatory)
- Proficiency configuring Power Automate workflows within SharePoint
- Hands-on experience with document control systems and regulated document lifecycle management, including IND authoring or FDA submission workflows
- Working knowledge of SharePoint access controls, library permissions, and compliance-aware configuration
- Provide SharePoint site administration support including troubleshooting and user access management
- Ability to work independently, manage deliverables remotely, and communicate with non-technical stakeholders
- Must be based in the United States
- Experience in clinical or drug development operational settings
- Comfort operating in a fast-moving startup environment and a collaborative, solution-oriented approach
- Assess and recommend opportunities to incorporate Microsoft 365 Copilot or SharePoint AI features
What We Do
BigHat’s mission is to improve human health by making it far easier to design advanced, next-generation antibody therapeutics. Our AI-enabled experimental platform integrates a high-speed characterization or “wet” lab with machine learning technologies to speed the antibody engineering process. When applied, these design capabilities have the potential to drive the development of new generations of safer and more effective treatments for patients suffering from today’s most challenging diseases. BigHat is backed by Section 32, Andreessen Horowitz, 8VC, Amgen Ventures, Bristol Myers Squibb, Quadrille, Grids Capital, AME Cloud Ventures, Innovation Endeavors and Gaingels.






