(Senior) Clinical Development Director

hace 1 día


Barcelona, España Novartis A tiempo completo

(Senior) Clinical Development Director - CVJoin to apply for the (Senior) Clinical Development Director - CV role at NovartisSummaryThe 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 RoleMain 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 publicationsLeading development of clinical sections of trial and program level regulatory documentsDriving 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 applicableOverseeing/conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical LeadSupporting (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 SafetyAs a clinical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boardsContributing 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 associatesMinimum RequirementsAdvanced degree in life sciences / healthcare (or clinically relevant degree) is required. PharmD or PhD is strongly preferredFluent oral and written EnglishMinimum 5 for CDD and 7 years experience for Snr CDD experience in clinical research or drug developmentWorking 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 levelDemonstrated ability to establish effective working relationship with key investigatorsWorking knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processesStrong 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.Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:



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