(Senior) Clinical Development Director
hace 6 días
Senior Clinical Development Director - CV 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. PharmD or PhD is strongly preferred Fluent oral and written English Minimum 5 years experience for CDD and 7 years experience for Snr CDD 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. 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: You’ll Receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Join 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: Why 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? Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Seniority level Director Employment type Full-time Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Novartis by 2x Sign in to set job alerts for “Director Clinical Development” roles. Other related roles Clinical Development Medical Director - CRMMadrid, Community of Madrid, Spain 6 days ago Senior Director, Medical Strategy Lead - DermatologyMadrid, Community of Madrid, Spain 5 days ago Clinical Development Medical Director - CardiovascularGreater Madrid Metropolitan Area 6 days ago Senior Director, Medical Strategy Lead- CardiologistMadrid, Community of Madrid, Spain 6 days ago Associate Director, Tech Quality AssuranceMadrid, Community of Madrid, Spain 6 days ago We’re unlocking community knowledge in a new way. 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Madrid, España Novartis A tiempo completoSenior 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,...
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