Key Responsibilities:

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.

Essential Requirements:

• Science based BS or MS with requisite experience and demonstrated capability.   Advanced degree (MS, Ph D, PharmD) considered a plus.
• Minimum 2-4 years of experience in pharmaceutical industry with relevant experience related to diagnostics, IVD or CDx development
  • Demonstrated   experience   of   successfully   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

Senior Manager:

• Science based BS or MS with requisite experience and demonstrated capability.   Advanced degree (MS, Ph D, PharmD) considered a plus.
• Minimum 4-6 years of experience in pharmaceutical industry with relevant experience related to diagnostics, IVD or CDx development
  • Demonstrated   experience   of   successfully   contributions to a IVD/CDx regulatory project(s)
  • 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

The pay range for this position at commencement of employment is expected to be between $114,100 and $211,900 (Manager) & $145,600 and $270,400 (Sr. Manager)/year; however, while salary ranges are effective from 1/1/25 through 12/31/2025, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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