Associate Director/Medical Director, Clinical Development

Climb Bio•Newton, MA

3d•$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