Senior Medical Director, Clinical Development

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Medical Director, Clinical Development based in United States.** This role offers the opportunity to shape the future of innovative therapies within a growing biotechnology environment focused on advancing treatments for complex immunological conditions. The Senior Medical Director, Clinical Development will provide strategic medical leadership across global clinical programs, helping translate scientific concepts into successful development strategies. You will collaborate with multidisciplinary teams to design, execute, and advance clinical trials while ensuring patient safety and regulatory excellence. The position requires deep expertise in immunology, inflammation, and clinical development, with the ability to influence research direction and program decisions. You will engage with internal teams, investigators, regulatory authorities, and key external stakeholders to accelerate meaningful therapeutic advancements. This is a high-impact opportunity for a clinical leader passionate about developing transformative medicines and improving patient outcomes. ### Accountabilities: The Senior Medical Director, Clinical Development will provide medical and scientific leadership throughout clinical development programs, supporting strategy creation, trial execution, regulatory activities, and cross-functional collaboration. This role requires strong clinical judgment, a deep understanding of therapeutic development, and the ability to guide complex programs in a dynamic environment. - Provide strategic clinical leadership and medical expertise for the development of innovative antibody-based therapies in rheumatology and related immunology indications. - Contribute to clinical development strategies, including study design, protocol development, execution planning, and interpretation of clinical trial results. - Support proof-of-concept and later-stage clinical programs by providing medical guidance throughout the development lifecycle. - Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, Biostatistics, Safety, and other development functions to ensure effective trial execution. - Provide medical and scientific input for regulatory documents, including IND submissions, investigator brochures, clinical study reports, and health authority responses. - Ensure compliance with global regulatory standards, Good Clinical Practice (GCP), and applicable requirements for clinical development activities. - Participate in safety monitoring activities, data review processes, and risk assessments to protect study participants. - Represent clinical development efforts in discussions with investigators, key opinion leaders, regulatory agencies, and other external stakeholders. - Support additional strategic and operational initiatives as needed to advance clinical programs. ## **Requirements:** The ideal candidate is an experienced physician leader with a strong background in clinical development within biotechnology or pharmaceutical environments. You should bring expertise in immunology or inflammation, strong scientific communication skills, and the ability to manage complex global development initiatives. - MD or equivalent medical degree required. - 4+ years of clinical development experience within the pharmaceutical or biotechnology industry. - Experience supporting immunology and inflammation (I&I) indications, with rheumatology experience strongly preferred. - Experience with antibody therapeutics and innovative biologic therapies preferred. - Proven experience designing, executing, and interpreting clinical trials. - Strong understanding of clinical trial methodology, statistics, GCP requirements, and global regulatory processes. - Experience preparing regulatory submissions and interacting with health authorities. - Ability to provide strategic medical guidan…