Clinical Development Director - Renal

Job Title

Clinical Development Director (CDD)

Location / Work Arrangement

London, UK or Dublin, Ireland - Hybrid (12 days per month on site)

Responsibilities

• Lead the delivery of all assigned clinical deliverables within the chosen section of a global clinical program or trial, including the clinical development strategy, clinical sections of individual protocols, clinical data review standards, and regulatory components.
• Contribute to and, if assigned, lead development and submission of clinical sections of regulatory documents such as Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to health authorities.
• Drive execution of the clinical program section in partnership with global line functions-clinical operations, trial leaders, data management, and statistics-ensuring proper data quality and analysis of trial results.
• Collaborate closely with data management and statistics teams to maintain data integrity and support accurate analysis of clinical trial outcomes.
• Act as manager of associates (e.g., associate CDDS) when appropriate, overseeing the overall risk benefit assessment of the assigned program section and contributing to Safety Management Team (SMT) activities.
• Provide clinical scientific input into Integrated Development Plans (IDP), Clinical Development Plans (CDP), and Clinical Trial Protocol (CTP) reviews, and develop disease specific clinical standards for new therapeutic areas.
• Co lead the Global Clinical Team (GCT) when a separate GCT exists for the program section, representing the section in Global Program Team (GPT) meetings and participating as a spokesperson in internal and external meetings or boards.
• Manage global safety reporting activities such as Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents in collaboration with medical monitors and patient safety teams.

Minimum Qualifications

• Advanced degree in life sciences/healthcare (PharmD or PhD strongly preferred).
• Minimum five years of experience contributing to all aspects of conducting global clinical trials (phases I-IV) in a matrix or academic/industry environment.
• Strong scientific writing skills and experience with regulatory submissions (IND, NDA/BLA, CTA/MAA).
• Advanced scientific acumen with the ability to analyze and interpret scientific literature and data.
• Demonstrated proficiency with data management, data quality, and statistical analysis of clinical trial results.
• Preferred knowledge or experience in the assigned therapeutic area.
• Ability to build strong scientific partnerships with internal and external stakeholders.