Clinical Development Medical Director
Vor 7 Tagen
**About the Role**:
The Clinical Development Medical Director (CDMD) is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective.
As CDMD in Renal development, you will have oversight of the clinical development for the assigned programs and drive 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.
Your responsibilities:
- Providing clinical leadership and strategic medical input for all clinical results in the assigned project or section of a clinical program
- Leading development of clinical sections of trial and program level regulatory documents
- Driving execution the assigned clinical program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable
- Supporting (Senior) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues
- Supporting the Clinical Development Head (CDH) by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new disease areas
**Diversity & Inclusion / EEO**:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Role Requirements**:
What you bring to the role:
- MD/medical degree is required in addition to sophisticated knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (including residency) and board certification or eligibility in Renal disease area preferred
- Minimum of 7 years of proven experience in clinical research or drug development
- Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required.
- 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, driving, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.
- Solid understanding of Renal disease area is required, with validated ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
- Demonstrated ability to establish effective scientific partnerships with key collaborators
- Solid understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes
- Previous global people management experience is preferred, though this may include management in a matrix environment.
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.
Division
Development
Business Unit
CLINICAL DEVELOPMENT DEV
Location
Switzerland
Site
Basel
Company / Legal Entity
Novartis Pharma AG
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
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