Senior Medical Director, Clinical Development

Careers Senior Medical Director, Clinical Development 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: Clinical Level: Senior Medical Director Location: San Carlos, CA or Remote Reporting Manager: SVP, Head of Clinical Development About the Opportunity: The Senior Medical Director, Clinical Development will serve as a key clinical and scientific leader and provide input on autoimmune clinical studies, clinical development program strategy and life cycle management. He/she will work closely with cross-functional groups that include Research, Translational Sciences, Clinical Operations, Regulatory, Patient Safety, Medical Affairs, and Commercial to ensure that Clinical Development scientific and medical strategies are aligned with broader corporate and patient needs. He/she is expected to have a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards. Role and Responsibilities: Provide key contributions to the development of a clinical development plan and lead the design and implementation of autoimmune clinical studies Serve as the clinical lead and medical monitor for one or more clinical study Contribute to and support the development of protocols, investigator brochures, clinical study reports and review clinical trial documents Provide clinical leadership and medical strategic input for all clinical deliverables: clinical sections of individual protocols, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications Review and interpret safety data on an ongoing basis to ensure overall safety of the molecule for the assigned section, and supports overall program safety reporting, and other safety related documents in collaboration with pharmacovigilance function) Conduct investigator meetings and lead site initiation visits with clinical trial investigators Translate findings from research and nonclinical studies into clinical development opportunities Interact with clinical investigators and thought leaders Provide clinical leadership and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial) Provide strategic support and work closely with company leadership on strategic and ...