Clinical Development Director, Cardio Renal
Vor 2 Tagen
13 The number of medicines Cardio Renal Metabolic diseases currently in development at Novartis.
Novartis is deeply committed to transforming the lives of people living with cardiovascular, renal and metabolic diseases. We believe that anyone living with these conditions has the right to a life free from pain, free from symptoms and free from disease - this is our vision for the future.
Our mission is to reimagine medicine to extend and improve people’s lives - and our overall company strategy to achieve this is to Focus Novartis as a leading medicine company powered by data science and advanced therapy platforms
The Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit is responsible for leading the strategic planning and management of the assigned renal clinical program(s) from an end-to-end clinical development perspective. As a CDD, 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, which can navigate in a matrix environment and adjust quickly to business needs.
Main responsibilities of this role are:
- 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/conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) 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
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
Minimum Requirements
- 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 trial(s) or program level
- Demonstrated ability to establish effective working relationship 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
**Division**
Global Drug Development
**Business Unit**
CARDIO-RENAL-METAB GDD
**Country**
Switzerland
**Work Location**
Basel
**Company/Legal Entity**
Novartis Pharma AG
**Alternative Country 1**
USA
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
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