Major Accountabilities 

• Providing or supporting clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
• Leading development of clinical sections of trial and program level regulatory documents
• Driving execution, the assigned clinical program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable
• Supporting (Senior) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues
• Supporting the Clinical Development Head (CDH) by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new disease areas
• As a medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
• May work with NIBR (Novartis Institute of Biomedical Research/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed.

Required Experience

Essential

• MD or equivalent medical degree is required in addition to advanced knowledge and clinical training.
• Clinical practice experience (including residency/fellowship) and board certification or eligibility in Nephrology
• Experience in clinical research or drug development preferred
• Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required.
• Experience in contributing to and accomplishing in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.
• Working knowledge of disease area is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
• Demonstrated ability to establish effective scientific partnerships with key stakeholders
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Accessibility and accommodation:

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in any order to receive more detailed information about essential functions of a position, please send an e-mail to [email protected]  and let us know the nature of your request and your contact information. Please include the job requisition number in your message.