Senior Clinical Development Director - Renal

Job Description Summary The Senior/Clinical Development Director (Sr*CDD) is the clinical/scientific expert responsible for leading a section of a global clinical program and/or trial. This may include an indication, a new formulation, or a specific development phase, or a large, complex trial, under the leadership of the GPCH. The Sr* CDD may also have a team leadership role for sections of clinical programs and/or global clinical trials, depending on the size, nature, and complexity. Job Description Major accountabilities: Supports and leads the delivery of all assigned clinical deliverables in the assigned section of a clinical program. These include clinical development strategies, clinical sections of protocols aligned with the Integrated Development Plans (IDP), data review standards, clinical components of regulatory documents/dossiers, and publications. Develops and leads the clinical sections of trial and program-level regulatory documents such as Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities. Drives the execution of the clinical program section in collaboration with global functions, including clinical operations, trial leaders, data management/analysis, and regional/country clinical development associates. Ensures ongoing clinical and scientific review of trial data. Collaborates with data management and statistics teams to ensure data quality and proper analysis of results. May serve as Program or Function Manager for associates (e.g., CDD or associate CDD). Supports GPCH in assessing the risk-benefit profile of the molecule for the assigned program section, may be a core member of the Safety Management Team (SMT), and contributes to safety reporting (PSURs, DSURs, etc.) in collaboration with medical monitors and safety teams. Member and potential co-lead of the Global Clinical Team (GCT), representing the section in GPT meetings and external/internal meetings/boards as assigned. Supports the Clinical Development Head (CDH) with clinical/scientific input into IDP/CDP and CTP reviews, and contributes to developing disease clinical standards. May assume other TA responsibilities as directed by the CDH. Minimum Requirements: Advanced degree in life sciences/healthcare (e.g., PharmD, PhD preferred). At least 10 years of experience in clinical research and global drug development, including Phases I-IV, with 5 years in clinical trial conduct in a global/matrix environment, preferably in late-phase development. Strong scientific writing skills. Experience with regulatory submissions (IND, NDA/BLA, CTA/MAA) preferred. Advanced scientific acumen with ability to analyze literature and data, with a strong affinity for data quality and analysis. Knowledge or experience in the assigned therapeutic area preferred. Proven ability to establish scientific partnerships with internal and external stakeholders. Minimum of 3 years people management experience, including in a matrix environment. Final job title and responsibilities will be aligned with the candidate's expertise level.

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