Associate Director Clinical Development
Job Summary
The Associate Director will drive early-phase (I-II) immunology clinical trials, focusing on autoantibody-driven diseases like myasthenia gravis and CIDP. This role involves designing robust protocols, providing medical monitoring, and collaborating with cross-functional R&D teams to advance the pipeline. You will be responsible for interpreting study data and supporting regulatory interactions to ensure patient-centered development.
Responsibilities
- Design and execute early-phase clinical protocols.
- Provide medical monitoring and clinical study oversight.
- Collaborate with cross-functional R&D and operations teams.
- Support regulatory submissions and health authority interactions.
- Monitor scientific landscape in neuroimmunology.
Required Skills
- MD, DO, or PharmD degree.
- Expertise in neuroimmunology or neuromuscular disease.
- Experience in clinical study execution and monitoring.
- Strong cross-functional collaboration and communication skills.
- Regulatory knowledge in drug development.
Job Details
Responsibilities:
- Partner with cross-functional teams including clinical operations, biostatistics, data management, regulatory, and safety to advance early-phase development programs.
- Contribute to clinical trial protocol design, development and execution for early phase neuroimmunology studies.
- Provide medical monitoring, clinical execution, and oversight of clinical studies to ensure patient safety.
- Serve as a contact for CRO and investigators to provide responses for protocol related questions.
- Provide scientific therapeutic expertise to internal and external stakeholders.
- Support data interpretation and clinical reporting for early phase clinical studies.
- Support preparation for health authority interaction and contribute to responses for regulatory questions related to clinical development activities.
- Contribute scientific contents for clinical protocols and other clinical development documents.
- Support risk mitigation strategies and provide clinical input for safety management plans.
- Assist in providing scientific content for clinical study documents such as protocols, amendments, investigator brochure, clinical study reports, and briefing materials.
- Champion patient-centered development approaches by incorporating disease burden, feasibility and patient experience considerations into study design.
- Monitor the external landscape in neuroimmunology and autoimmune disease, including competitive intelligence, evolving standards of care, and relevant scientific advances.
Required Skills:
- MD/DO (or international equivalent) or PharmD with relevant experience required.
- Subspecialty experience in neurology or neuromuscular medicine, or prior drug development experience in neuromuscular or neuroimmunology diseases is strongly preferred.
- 0-2+ years' experience in the biotech/pharmaceutical industry with additional experience in academic or clinical research.
- Prior experience in medical monitoring or investigator/sub-investigator role.
- Experience contributing to clinical study execution and/or oversight and working cross-functionally with R&D partners.
- Strong communication skills (written and verbal).
- Deep scientific and clinical understanding of neuroimmunology/autoimmune disorders.
- Ability to manage multiple priorities in fast-paced environment.
- Ability to travel domestically and internationally, as required for business needs.