(Senior) Clinical Development Director

hace 6 días


Madrid, España Novartis A tiempo completo

Senior Clinical Development Director - CVSummary: 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 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 years experience for CDD and 7 years experience for Snr CDD 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 organizationFinal 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 expertiseNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYou'll ReceiveYou can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.https://www.novartis.com/careers/benefits-rewardsJoin our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:https://talentnetwork.novartis.com/networkWhy Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewardsSeniority levelDirectorEmployment typeFull-timeJob functionResearch, Analyst, and Information TechnologyIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Novartis by 2xSign in to set job alerts for "Director Clinical Development" roles.Other related rolesClinical Development Medical Director - CRMMadrid, Community of Madrid, Spain 6 days agoSenior Director, Medical Strategy Lead - DermatologyMadrid, Community of Madrid, Spain 5 days agoClinical Development Medical Director - CardiovascularGreater Madrid Metropolitan Area 6 days agoSenior Director, Medical Strategy Lead- CardiologistMadrid, Community of Madrid, Spain 6 days agoAssociate Director, Tech Quality AssuranceMadrid, Community of Madrid, Spain 6 days agoWe're unlocking community knowledge in a new way. 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