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Clinical Development Director
4 weeks ago
Join to apply for the Clinical Development Director - Renal role at Novartis Ireland
Summary The Clinical Development Director (CDD) is the clinical/scientific expert who may be assigned as 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 have a team leadership role for sections of clinical programs and/or global clinical trials, depending on the size, nature and complexity.
About The Role
- 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., PSURs, 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); represents the section 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
Minimum Requirements
- Work Experience:
- 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 (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 with a strong affinity for data quality and analysis
- Preferred knowledge and/or experience of assigned therapeutic area
- Demonstrated ability to establish strong scientific partnerships with key internal and external stakeholders
- ≥ 3 years people management experience required; this may include management in a matrix environment
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives. Be part of this mission and join us. Learn more about our strategy and people here: https://www.novartis.com/about/strategy/people-and-culture
You'll receive: Details on benefits and rewards are in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards
Commitment To Diversity And Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected, join the Novartis Network: https://talentnetwork.novartis.com/network
Why Novartis: We collaborate, support and inspire each other to achieve breakthroughs that change patients' lives. Explore opportunities at https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Sign up to stay connected and learn about suitable opportunities: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about ways we'll help you thrive: https://www.novartis.com/careers/benefits-rewards
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