Clinical Development Medical Director Immunology

Your responsibilities include, but are not limited to:

• Provide clinical leadership and medical strategic input for deliverables in the assigned project/program. Deliverables may include sections of individual protocols consistent with the IDP, data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications (e.g., IBs, Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
• Drive execution of the section of the program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates
• Oversee/conduct medical and scientific review of trial data with Clinical Scientific Expert(s). May be the Program Manager of other associates (e.g.., CSE). May function as study medical monitor
• Support SR/GPCH in ensuring overall safety of the molecule. May be a core member of the Safety Management Team (SMT), and supports program safety reporting (e.g., PSURs, DSURs, and safety related documents) in collaboration with Patient Safety
• Support the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for disease areas.
• Provide support to the (Sr.) GPCH or TAH in interactions with external partners (e.g., regulatory authorities, KOLs, data monitoring boards, AD Boards, patient advocacy groups), internal partners (e.g., CTT, Research, Translational Medicine, GMA, Marketing, HE&OR), and decision boards)
• Work with BR (Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences together with additional matters
• Ensure career development of Program reports and clinical colleagues through active participation in performance management and talent planning processes. Provide on-boarding, training, & mentoring support
• Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise.
• May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)

Minimal Requirements:

• MD (or equivalent medical degree) is required.
• Medical Board certification preferred. 4+ years Clinical practice experience (including residency) is preferred
• Possess advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) is required.
• 5+ years’ experience in clinical research or drug development from the pharma/biotech industry spanning clinical activities in Phases I through IV.
• 3+ years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) in a global/matrix environment
• Demonstrate ability to establish strong scientific partnership with key partners
• Need thorough knowledge of GCP, trial design, statistical analysis methodology, and regulatory/ clinical development process

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(link is external)

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network(link is external)

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