Clinical Development Director
4 weeks ago
Join to apply for the Clinical Development Director - Renal role at Novartis Ireland
OverviewThe Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit leads the strategic planning and end-to-end management of the assigned clinical program(s). As the CDD in the Renal therapeutic area, you will have oversight of the clinical development for the assigned programs and drive the execution of the clinical development plan. In addition, you will enable an empowered organization that can navigate a matrix environment and adjust quickly to business needs.
Major accountabilities- Providing clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program. Clinical deliverables may include clinical sections of individual protocols or sub-studies consistent with the Integrated Development Plans (IDP), clinical data review, program-specific standards, clinical components of regulatory documents/registration dossiers, and publications.
- Leading development of clinical sections of trial and program-level regulatory documents.
- Driving execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, if applicable.
- Overseeing and conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Experts, with appropriate oversight from Medical Lead.
- Supporting (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section and may be a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety.
- As a clinical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards.
- Contributing to scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training and may be the Program Manager of other associates.
- Advanced degree in life sciences / healthcare (or clinically relevant degree) is required. PharmD or PhD is strongly preferred.
- Fluent oral and written English.
- Minimum 7 years experience in clinical research or drug development.
- Working knowledge of the assigned disease area is desired, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trials or program level.
- Demonstrated ability to establish effective working relationships with key investigators.
- Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
- Strong communication skills with the ability to work in a cross-functional and global organization.
Our purpose is to reimagine medicine to improve and extend people's lives, and our vision is to become the most valued and trusted medicines company in the world. Be part of this mission and join us.
Commitment To Diversity And InclusionNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Seniority level- Director
- Full-time
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