At a Glance
- Tasks: Lead global clinical programs and trials, ensuring high-quality data and strategic execution.
- Company: Join Novartis, a leader in innovative healthcare solutions.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Diverse and inclusive workplace committed to innovation and excellence.
- Why this job: Make a real impact in drug development and patient care while collaborating with top experts.
- Qualifications: Advanced degree in life sciences and extensive clinical research experience required.
The predicted salary is between 80000 - 100000 £ per year.
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. 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.
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.
- May 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. PharmD, 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.
*Final job title (Clinical Development Director, Level 6/ Senior Clinical Development Director, Level 6) and associated responsibilities will be commensurate with the successful candidate’s level of expertise.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Clinical Development Director - Renal employer: Dormont Manufacturing Co
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work environment in the heart of London or Dublin. Our commitment to employee growth is evident through comprehensive training programs and opportunities for advancement within our global clinical teams. With a hybrid work model that promotes work-life balance and a culture that values diversity and collaboration, we empower our Clinical Development Directors to lead impactful projects that contribute to the health and well-being of communities worldwide.
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