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Summary
The Associate* 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 CDD in the CV 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
Major accountabilities:
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***
Minimum > 3 years (Associate) or 7 years experience (CDD) in clinical research or drug development
Working knowledge of the assigned disease area 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 and associated responsibilities will be commensurate with the successful candidates’ level of expertise.
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-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment To Diversity And Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
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? https://www.novartis.com/about/strategy/people-and-culture
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Benefits 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-rewards
Seniority level Seniority level Mid-Senior level
Employment type Employment type Full-time
Job function Job function Research, Analyst, and Information Technology
Industries Pharmaceutical Manufacturing
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