Technical Architect (H / F)

The Precision Medicine Director (PMD) develops the Precision Medicine strategy and plans for a given program. The PMD leads and oversees all aspects of implementation and execution of the program PM strategy, supporting GCT / GPT including development of clinical biomarker assays with a medical purpose and (companion) diagnostics to support patient selection and stratification ensuring regulatory approval, technical market access and optimised commercial value. Acts as Precision Medicine Subject Matter Expert within the GCT / GPT.

Job Description

Major accountabilities:

1. Develops the assigned program Precision medicine strategy aligned to the disease area strategy in support of a GCT / GPT and ensures seamless execution for the success of the program.
2. Leads cross functional biomarker sub teams for molecular epidemiology, assay development for patient selection / stratification, data analyses / interpretation and data reporting.
3. Serves as core member of the BDST and may lead BDST. Serves as subject matter expert at the Global Clinical Team (GCT) and / or Clinical trial team (CTT) as applicable.
4. Contributes to the Dx target product profile (DxTPP), and the overall IVD / CDx development strategy and plan.
5. Avoids strategic and operational crises by proactively identifying and managing potential risks to the program(s).
6. Authors the biomarker / CDx portions of key clinical documents including Clinical Development Plan, Investigator Brochures, Clinical study protocols and Study Reports.
7. Supports regulatory submissions by acting as biomarker / clinical Dx subject matter expert within the GPT team.
8. May support exploratory / scientific external academic collaborations to support biomarker data generation.
9. Ensures compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93 / 42 / EEC, 98 / 79 EC, and the requirements of the Novartis CDx Quality Management System.

Work Experience:

1. 6 years industry experience
2. 3+ years multi / cross functional leadership experience within either Oncology, Immunology, Neuroscience, or Cardiometabolic business unit.
3. Excellent knowledge of diagnostics and associated regulatory requirements.
4. Expert leadership skills demonstrated in cross functional teams.
5. Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.
6. Outstanding verbal and written communications.

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, please send an e-mail to [emailprotected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.