What are the responsibilities and job description for the Director, Medical Writing position at septerna?
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.
We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
For more information see: www.septerna.com.
About the Role
Septerna is seeking an experienced and motivated Director of Medical Writing to lead the development and execution of medical writing activities across our clinical programs. This individual will be responsible for producing high-quality clinical and regulatory documents that support global submissions and ensure clear, accurate, and compliant communication of scientific and clinical data. The ideal candidate will be a hands-on leader who thrives in a fast-paced, growing biotech environment and enjoys collaborating across functions to deliver high-impact results. This position reports into the VP, Regulatory Affairs.
Responsibilities
- Lead the medical writing function and establish best practices, processes, and standards to support clinical and regulatory documentation.
- Author, review, and manage the development of clinical and regulatory documents, including protocols, investigator brochures, clinical study reports (CSRs), INDs, CTAs, briefing packages, and clinical sections of regulatory submissions.
- Collaborate closely with Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, and Nonclinical teams to ensure accuracy, consistency, and alignment across documents.
- Serve as the medical writing lead on cross-functional project teams, ensuring deliverables meet timelines and quality standards.
- Oversee external medical writing vendors and contractors, ensuring consistency with Septerna’s quality and style guidelines.
- Contribute to regulatory submission planning and authoring strategy, including preparation for agency interactions.
- Support publication planning and development, including abstracts, posters, and manuscripts as needed.
- Mentor and provide strategic direction to team members as the company grows.
Qualifications
- Bachelor’s degree in life sciences or related field; advanced degree (PhD, PharmD, or MS) preferred.
- Prior managerial experience (including consultants) preferred.
- 10 years of medical writing experience in the biopharmaceutical industry, with a focus on clinical and regulatory documents.
- Proven experience authoring and managing documents supporting INDs, CTAs, and other regulatory submissions.
- Proficient in the drug development process with a deep understanding of ICH, FDA, and EMA guidelines and requirements.
- Exceptional attention to detail, organization, and scientific accuracy.The ability to summarize and present complex scientific and clinical data effectively.
- Strong leadership, problem-solving, communication, and cross-functional collaboration skills.
- Ability to manage multiple projects and priorities in a dynamic, fast-paced environment.
- Comfortable working hands-on while also building scalable infrastructure for future growth.
Salary : $225,000 - $245,000