Senior Clinical Development Director responsible for strategic planning in clinical programs at Novartis. Leading clinical development in Cardiovascular/Metabolic field with global collaboration.
Responsibilities
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.
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 5 for CDD and 7 years experience for Snr CDD experience in clinical research or drug development
Working knowledge of the assigned disease area (Cardiovascular/Metabolic) 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.
Benefits
Health insurance
Professional development
Job title
Clinical Development Director – Cardiovascular, Metabolic
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