Precision Medicine Associate Director
Precision Medicine Associate Director
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Job Description
Job Description Summary
The Precision Medicine Associate Director (PMaD) provides clinical drug development scientific and technical expertise for successful implementation and execution of the Precision Medicine plans for clinical studies in a given program with a focus on ensuring timely execution to meet studies timelines.#LI-Hybrid
Primary Location: London UK
Other Locations: Dublin Ireland
Relocation Support: This role is based in London/Dublin. Novartis is unable to offer relocation support: please only apply if accessible.
Job Description
Responsibilities:
Serves as core member of the BDST and as subject matter expert at the Global Clinical Team (GCT) and/or Clinical trial team (CTT) as applicable. As well as externally e.g. steering committees.
Contributes to the Dx target product profile (DxTPP) and the overall IVD/ CDx development strategy and plan.
Authors the biomarker/CDx portions of the study protocols and clinical study reports.
Avoids strategic and operational crises by proactively identifying and managing potential risks to the program(s) and communicate them timely to GCT/CTT to minimize impact on program.
Supports regulatory submissions by acting as biomarker/clinical Dx subject matter expert within the GCT/CTT team.
Partners with CBS and other internal stakeholders to ensure all aspects of data collection and analysis are executed with high quality including statistical analysis plan data formatting and transfer specifications eCRF page design and monitoring plans for biomarker study samples.
May Support exploratory/scientific external academic collaborations to support biomarker data generation.
Ensures Compliance to applicable US and international Medical Device regulations and standards including but not limited to 21 CFR 820 ISO/42/EEC 98/79 EC and the requirements of the Novartis CDx Quality Management System.
Essential for the role:
Education: MD or Ph.D. OR MD/Ph.D. with minimum of 6 years of experience in the field of precision medicine including CDx/IVD and minimum of 3 years in the pharmaceutical industry.
3 years multi/cross functional leadership experience within either or Oncology Immunology Neuroscience Cardiometabolic business unit.
Excellent knowledge of diagnostics and associated regulatory requirements
Expert leadership skills demonstrated in cross functional teams.
Expert skills to facilitate/optimise contribution of team members as individuals and member of cohesive team.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Budget Management Clinical Research Clinical Trial Protocol Clinical Trials Coaching Cross-Functional Teams Data Analysis Learning Design Lifesciences Risk Management Risk MonitoringRequired Experience:
Director
Employment Type
Full-Time
