Clinical Development Director - Renal

Summary
The Clinical Development Director (CDD) is the clinical/scientific expert and, if assigned, the clinical development lead of a section of a global clinical program and/or trial (e.g., an indication, a new formulation, or a specific development phase) or a large, complex trial, under the leadership of the GPCH. The CDD may be assigned to have a team leadership role for sections clinical programs and/or global clinical trials, depending on the size, nature and complexity.

About the Role

Title:

Clinical Development Director

Office

Location:

London UK, Dublin Ireland, Barcelona or Madrid Spain.

Hybrid:  12 days per month on-site

Major Accountabilities

Supports and, if assigned, leads delivery of all assigned clinical deliverables in the assigned section of a clinical program. Clinical deliverables may include the clinical development strategy for assigned program section(s), clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review program specific standards, clinical components of regulatory documents/registration dossiers, and publications.

Contributes and, if assigned, leads development and delivery of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities).

Drives execution of the section of the clinical program in partnership with global line functions, in particular clinical operations, trial leaders and data management/analysis, and regional/country clinical development associates.

Ensures ongoing clinical and scientific review of clinical trial data.

Works in close collaboration with the data management and statistics teams to ensure proper data quality and analysis of clinical trial results.

Might be the Program or Function Manager of associates (e.g., CDD or associate CDD).

Supports GPCH in assessing overall risk‑benefit of the molecule for the assigned section of the clinical program, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with the medical monitor, CDMD and Patient Safety.

Member and, if assigned, may co‑lead the Global Clinical Team (GCT), if there is a separate GCT for the assigned program section. Represents the section when assigned in Global Program Team (GPT) meetings, and as the section spokesperson in internal and external meetings/boards, as assigned.

Supports the Clinical Development Head (CDH) by providing clinical/scientific input into IDP/CDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the CDH.

Minimum Requirements

Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Pharm

D, or PhD strongly preferred.

≥ 7 years of involvement in clinical research, global drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ≥ 5 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry. Experience in late phase clinical development strongly preferred.

Solid scientific writing skills.

Experience with regulatory submissions (IND, NDA/BLA, CTA/MAA) preferred.

Solid and advanced scientific acumen and ability to analyze and interpret scientific literature and data. Strong affinity with data, data quality and analysis.

Preferred knowledge and/or experience of assigned therapeutic area.

Demonstrated ability to establish strong scientific partnership with key internal and external stakeholders.

≥ 3 years people management experience required; this may include management in a matrix environment.

Seniority level
Director

Employment type

Full‑time

Job function
Research, Analyst, and Information Technology

Industries
Pharmaceutical Manufacturing

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