Associate Director/Medical Director, Clinical Development
Climb Bio • Newton, MA59d • $187,500 - $276,000 • Onsite
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Associate Director/Medical Director, Clinical Development
Climb Bio•Newton, MA
•$187,500 - $276,000•Onsite
About The Position
Reporting to 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.
Requirements
- MD (or international equivalent) required
- 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.)
- 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
- Associate Director: 2–5 years of clinical development experience in biotech/pharma or relevant academic clinical research
- Associate Director: Exposure to clinical trial design, execution, and/or medical monitoring
- Medical Director: 5+ years of clinical development experience in biotech/pharma
- Medical Director: Demonstrated leadership in clinical trial design and execution across one or more programs
Nice To Haves
- Board certification in Nephrology (or Internal Medicine with nephrology subspecialty training) strongly preferred
- Experience in early- and/or late-stage clinical development preferred
Responsibilities
- 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
Benefits
- Medical
- Dental
- Vision
- Life & Disability
- 401k company match
- generous paid time off
- equity
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
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