Salary Range:
96036.50 - 178353.50Job Description Summary
#LI-HybridJob Description
Major accountabilities:
Your responsibilities will include but are not limited to:
Providing 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 hands on
Driving execution of 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 BR (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.
Minimum Requirements:
MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (including residency) and board certification or eligibility in disease area preferred
>7 years of experience in clinical research or drug development is preferred
Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV is required.
Working knowledge of cardiovascular disease and coagulation 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
Prior experience in regulatory submissions is strongly preferred
Demonstrated ability to establish effective scientific partnerships with key stakeholders
Working knowledge of GCP clinical trial design statistics and regulatory and clinical development processes
Previous global people management experience is preferred though this may include management in a matrix environment.
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.
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 receive:
Competitive salary Short term incentive bonus Pension scheme Health insurance 25 days annual leave Flexible working arrangements Employee recognition scheme learning and development opportunities
Benefits and Rewards:Learn about all the ways well help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
Skills Desired
Clinical Trials Cross-Functional Teamwork Data Analysis Data Monitoring Drug Development Drug Discovery Process Medical Research Medical Strategy (Inactive) People ManagementRequired Experience:
Director
(Senior) Clinical Development Medical Director • London, England, UK
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