摘要
implementation of strategic plans for development of diagnostics, including companion diagnostics, as they pertain to the Novartis innovative medicines portfolio, including its marketed products. The RDM works with oversight of senior members of the RA Precision Diagnostics Team including the TA and Diagnostics Lead on strategies and submissions including companion diagnostics, in close collaboration with internal RA Disease Unit associates, associates of Digital, Data and Clinical Innovation (DDCI) at Novartis as well as Partner Companies that develop diagnostics and ensures adherence to regulatory requirements. The RDM will also provide regulatory support including tactical and technical regulatory direction for clinical trial assays to ensure compliance with regulations on diagnostics.
About the Role
Major Accountabilities
Regulatory Strategy and Implementation
• Supports the diagnostics regulatory strategy for precision IVDs and CDx (e.g. US, EU, Japan, China).
• With support of the RA TA and Diagnostics Lead, responsible for submissions in the premarket as well as post-market space including investigational Device Exemptions (IDE), Significant Risk Determinations, Performance Study Applications (PsA) and pre-market authorization submissions
• With oversight of the RA TA and Diagnostics Lead, works to ensure diagnostic regulatory input for early development and late- stage programs is incorporated into the overall drug development strategy to ensure regulatory requirements pertaining to IVD, CDx and LDT regulations are met
• As needed, partner with RA country organizations to align on local regulatory requirements for precision IVDs and CDx and deliver timely submissions as appropriate including annual reports and notifications
• Facilitates preparation, filing, finalization of briefing books including coordination and planning for pre-Submission or other meetings with HAs related to precision diagnostics and CDx development. Participation in HA meetings as appropriate
• Develops, manages, and implements plans for timely response to HA requests and coordinates of any applicable follow-up activities.
• Member of RA subteam and Biomarker Development Subteam (BDST) as appropriate
Training and Compliance
Support compliance activities for Novartis clinical trials as they relate to global regulations on precision diagnostics and CDx, such as European IVDR Help ensure regulatory compliance of Partner companies for CDx development and IVD deliverables related to our portfolio, as appropriate and elevate to RA Diagnostic Lead where appropriate Support roll-out of new procedures, SOPs and working practices and training related to IVD and CDx development.
Performance Indicators
Successful implementation of regulatory diagnostics strategies with timely submissions for precision IVDs and CDx Full compliance with IVD and LDT rules for our clinical trials Identification of precision IVD and CDx needs for Novartis programs Strong partnership with RA Diagnostics Team members and the RA community Adherence to Novartis Policies and guidelines.
Experiences & Skills
- Minimum 2-4 years of experience in the pharmaceutical industry with relevant experience related to diagnostics, IVD or CDx development
- Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MS, Ph D, PharmD) considered a plus.
- Demonstrated experience of successful contributions to a IVD/CDx regulatory project(s) and/or submission
- Experience in the diagnostic, IVD and/or CDx industry
- Understanding of IDE, MAA, NDA/BLA, 510(k), PMA submission(s)
- Understanding of assay validation and CLIA
- Understanding of clinical trials
- Strong interpersonal, communication and negotiation skills
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? : http://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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: http://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? http://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: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
