Associate Director – Medical Director, Clinical Development

Responsibilities

• Serve as a clinical lead within the development organization
• Contribute to the development and execution of Clinical Development Plans (CDPs) aligned with the Target Product Profile (TPP) and regulatory requirements
• Support study design, including protocol development, endpoints, and statistical considerations
• Translate clinical and emerging data into actionable insights to inform program strategy
• Partner with Clinical Operations to ensure high-quality study execution and achievement of key milestones
• May serve as Medical Monitor, overseeing patient safety, safety signal detection, and benefit-risk assessment
• Provide medical oversight of CROs, investigators, and study teams
• Contribute to preparation of regulatory submissions (e.g., IND/CTA, briefing documents, responses to health authorities)
• Participate in interactions with regulatory agencies, key opinion leaders (KOLs), and advisory boards
• Represent the company at investigator meetings, site initiations, and scientific conferences
• Partner with Non-clinical development, Clinical Pharmacology, Clinical Operations, Regulatory, and Data Science teams to support program development and data interpretation
• Support internal governance discussions and program decision-making
• Contribute to the authorship of clinical documents (protocols, IBs, CSRs) and scientific publications (abstracts, posters, manuscripts)
• Develop and deliver training materials for CROs, CRAs, and study sites

• MD (or international equivalent) required
• Board certification in Nephrology (or Internal Medicine with nephrology subspecialty training) strongly preferred
• Deep understanding of nephrology, including diseases such as IgA nephropathy, membranous nephropathy, and other immune-mediated kidney diseases
• Experience with clinical trial methodology, GCP/ICH, and regulatory requirements (FDA, EMA, etc.)
• Experience in early- and/or late-stage clinical development preferred
• Strong collaboration skills in a matrixed environment
• Ability to synthesize complex data and communicate clearly to diverse audiences
• High accountability, adaptability, and comfort in a fast-paced, small-company setting
• Patient-focused, science-driven, and aligned with a high-performance culture.