Director/ Senior Director, Medical Writing

Careers Director/ Senior Director, Medical Writing About the Company: Dren Bio is a privately held, clinical-stage biopharmaceutical company pioneering the discovery and development of first-in-class antibody therapeutics for the treatment of cancer, autoimmune disorders, and other serious diseases. Leveraging our wholly owned technologies, we have built a robust R&D pipeline, including two clinical-stage candidates currently being evaluated across multiple ongoing clinical studies. Our lead clinical candidate, dibotatug, is designed to induce antibody-mediated killing of a specific cell type implicated in a range of oncology and autoimmune indications. In addition, we have launched multiple programs from our proprietary Targeted Myeloid Engager and Phagocytosis Platform, a multispecific antibody-based technology engineered to selectively engage a novel phagocytic receptor expressed on myeloid cells (antigen presenting cells) for the targeted depletion of pathologic cells and other disease-causing agents. Data generated using the platform support its broad therapeutic potential, including initial programs focused on oncology, immunology, and neurology. Importantly, multispecific antibodies generated from the platform are specially designed to activate phagocytic mechanisms only in the presence of disease targets, potentially offering a superior safety profile compared to other immunomodulatory therapies. For more information, please visit our website at www.drenbio.com. Function: Regulatory Affairs Level: Director/ Senior Director Location: San Carlos, CA (Remote candidates may be considered) Reporting Manager: SVP, Regulatory Affairs About the Opportunity: Dren Bio is seeking a highly motivated, well-organized, and skilled Director/Senior Director, Medical Writing to provide strategic and operational leadership across programs spanning early- and late-stage development. This role is responsible for delivering high-quality regulatory and clinical documents that support global development and registration strategies. This individual will work closely with stakeholders in Clinical Development, Clinical Operations, Biostatistics, and other functional areas and manages medical writing service providers to develop Regulatory documents, including but not limited to NDA/MAA and eCTD submissions, clinical study protocols and clinical protocol amendments, clinical study reports, patient narratives, clinical development plans, IND submissions, integrated summary reports, , and Investigator Brochures, etc. Role and Responsibilities: Prepare documents in accordance with internal SOPs as applicable, and relevant ICH and regulatory/industry guidelines. Critically analyze complex data and information and collaborate with clinical, medical, and biostatistics/data science teams to present data in clear, scientifically accurate documents. Ensure adherence to timelines. Lead cross-functional document reviews, resolve feedback, and drive documents to approval Plan and manage medical writing activities and resources across multiple programs Participate in and oversee vendors for the writing, QC editing, and confirmation of the scientific and medical accuracy of clinical and regulatory documents Work effectively with cross-functional teams by creating an atmosphere of openness and trust Provide support in development of submission-ready documents Represent department in audits and interdepartmental working groups Education, Experience and Qualification Requirements: Bachelor’s degree in life sciences or a related discipline is the minimum; advanced degrees (Master's, PharmD, or PhD) are highly preferred 10-12 years of medical writing experience, in biotech/pharmaceutical industry, including 5+ years in a leadership role supervising a medical writing team Proven leadership experience supporting INDs and at least...