Senior Clinical Development Director - CV

(Senior) Clinical Development Director - CV
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Summary
The Senior Clinical Development Director (CDD) in the Cardio Renal & Metabolic (CRM) Development Unit is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective. As a Senior CDD in the Cardiovascular/Metabolic TA, 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.

About

The Role
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

Minimum Requirements

Advanced degree in life sciences / healthcare (or clinically relevant degree) is required. Pharm

D 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) 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

“Final job title (Associate Clinical Development Director, level 5 / Clinical Development Director, Level 6/ Senior Clinical Development Director, Level
6) and associated responsibilities will be commensurate with the successful candidates’ level of expertise”

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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