Backed by NEA and Norwest.
About the role
MBX Biosciences is seeking an experienced and dynamic Senior Director of Medical Writing to establish and lead our Medical Writing department. This full-time leadership role will be instrumental in building a high-performing team and developing robust processes to support clinical and regulatory documentation across the organization.
What they're looking for
- Lead and manage the Medical Writing team (including internal and external writers), providing guidance, mentorship, and professional development opportunities
- Oversee the preparation, review, and submission of clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions
- Ensure all documents are accurate, scientifically sound, and compliant with regulatory guidelines and company standards
- Collaborate with clinical, regulatory, and scientific teams to gather and interpret data, ensuring clear and effective communication of complex scientific information
- Develop and implement medical writing processes, templates, and best practices to enhance efficiency and quality
- Stay current with industry trends, regulatory requirements, and best practices in medical writing
More about this role
Position Summary
MBX Biosciences is seeking an experienced and dynamic Senior Director of Medical Writing to establish and lead our Medical Writing department. This full-time leadership role will be instrumental in building a high-performing team and developing robust processes to support clinical and regulatory documentation across the organization. The successful candidate will be responsible for overseeing the creation of high-quality clinical and regulatory documents, ensuring alignment with industry standards and global regulatory requirements. This role requires exceptional leadership, deep expertise in medical writing, and a collaborative mindset to work effectively across cross-functional teams, including Clinical Development, Regulatory Affairs, Quality, and Program Management. This individual will report directly to the Senior Vice President of Regulatory & Quality and will play a key role in shaping the strategic direction of medical writing within the company.
Key Responsibilities
- Lead and manage the Medical Writing team (including internal and external writers), providing guidance, mentorship, and professional development opportunities.
- Oversee the preparation,...
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