Clinical Development Director – Renal

Overview

In this role you lead and shape the clinical development strategy for a section of a global program, collaborating with global functions to deliver clinical data, regulatory documents, and safety reporting. You will guide scientific input, data interpretation, and risk–benefit assessments, often acting as a program or function lead for a team. This position offers impact across trials and regulatory submissions within a high‑profile, cross‑functional environment. You will be at the intersection of science, clinical execution, and regulatory strategy, helping to advance therapeutic programs.

Responsibilities

• Lead delivery of clinical deliverables for assigned program sections
• Develop clinical sections of protocols and IDP-aligned documents
• Prepare and deliver regulatory documents (IBs, briefing books, PSURs/DSURs) and responses
• Drive program execution in partnership with clinical operations, data management and statistics
• Ensure ongoing clinical and scientific review of trial data; oversee data quality and analyses
• Possibly serve as (co-)Program/Function Manager for associates
• Assess overall risk-benefit and support safety reporting in collaboration with SMT and medical safety leads
• Represent the section in GPT meetings and external engagements
• Provide input to IDP/CDP reviews and contribute to disease standards
• May take on other therapeutic area responsibilities as directed by CDH

Key requirements

• 7 years in clinical research and global drug development (Phases I–IV)
• 5 years conducting trials in a global/matrix pharma environment
• Experience in late-phase development preferred
• Solid scientific writing and data interpretation skills
• Experience with regulatory submissions (IND, NDA/BLA, CTA/MAA)
• 3 years people management experience in matrix settings

• Strong scientific partnering with internal and external stakeholders
• Excellent communication and collaboration across cross-functional teams
• Data quality mindset and analytical rigor
• Clinical trial design and execution
• Regulatory documentation development (IBs, briefing books)
• PSURs/DSURs and safety reporting

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