Associate Director/Medical Director, Clinical Development

Reporting the Head of Clinical Development, the Associate Director/Medical Director, Clinical Development will serve as a clinical lead within the development organization, supporting the design, implementation, and execution of clinical development programs in nephrology and related immune-mediated diseases. This individual will work cross-functionally to advance programs from early- through late-stage development, contribute to clinical strategy, and ensure high-quality execution aligned with regulatory requirements and Climb Bio's mission.

Key Responsibilities:

Clinical Development & Strategy

• 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

Trial Execution & Medical Oversight

• 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

Regulatory & External Engagement

• 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

Cross-Functional Collaboration

• 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

Scientific Communication

• 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

Qualifications:

Education Training

• MD (or international equivalent) required
• Board certification in Nephrology (or Internal Medicine with nephrology subspecialty training) strongly preferred

Technical Expertise & Competencies

• 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

Experience:

Associate Director:

• 2-5 years of clinical development experience in biotech/pharma or relevant academic clinical research
• Exposure to clinical trial design, execution, and/or medical monitoring

Medical Director:

• 5+ years of clinical development experience in biotech/pharma
• Demonstrated leadership in clinical trial design and execution across one or more programs

Additional Information

• International and domestic travel as needed to support clinical programs

This position will be based out of our Wellesley, MA office. Base salary offered may vary depending on the individual's skills, experience, and competitive market value.

• Associate Director Salary Range: $187,500 - $254,000
• Director Salary Range: $205,000 - $276,000

Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, Life & Disability, 401k company match, generous paid time off, and equity.