May 18, 2022

Job Description

2005! That’s the year that Novartis began exploring Precision Medicine to extend and improve the lives of patients, by enabling the regulatory approval and commercial sale of transformative therapies.

Precision Medicine (PM) is an approach for prevention, diagnosis, treatment, and monitoring of disease that considers individual variability in biology, environment, and lifestyle for each person (source: NIH). Patient biomarker data and diagnostic assays drive healthcare decision-making by helping physicians identify patients for the right treatment and monitor their disease. Beyond biomarkers and companion diagnostics, precision medicine supports the Novartis pipeline by facilitating clinical trial design and execution, accelerating drug development, and informing early pipeline choices. By using advances in biology, technology, and data & digital solutions, Novartis Precision Medicine continues to innovate in our quest to disrupt treatment paradigms and reimagine medicine.
The Global Biomarker Associate Director (GBaD), supports the Disease Area Global Biomarker Diagnostic Leader (GBDL) by, contributing to the execution of the Oncology Precision Medicine Strategy for a given disease area GPT. The GBaD contributes to the implementation and execution of the disease area Precision Medicine strategy, with predominant focus on timely execution of biomarker activities to support decision making in the GPT and ensuring regulatory approval, of any CDx assays in collaboration with the CDx Regulatory team.

Your Responsibilities include, but are not limited:
• Contributes to the implementation & execution of the biomarker & diagnostic strategy
• Ensures timely execution of assay development for patient selection, stratification, pharmacodynamics, correlative studies and CDx development for clinical trials by working with internal stakeholders (global line functions) and external partners (clinical research organizations, • Academic Labs, clinical labs and diagnostic partners) for assigned program/studies with limited oversight
• Supports regulatory submissions by acting as subject matter expert within the team. Contributes scientific and technical sections of key regulatory documents including INDs, FDA briefing books, and submission documents (including NDAs, IDEs & PMAs). Coordinates data requirements with reference labs to support submission.
• Partners with Biomarker Trial Heads (BTHs) and other internal stakeholders to ensure all aspects of data collection and analysis are executed with quality, including correlative science analysis plan, data formatting and transfer specifications, eCRF page design, and monitoring plans for correlative study samples.
• Acts as core member of the International Clinical Team
• Functionally reports to the Global Biomarker & Diagnostic Head in GDD and operationally to the Global Biomarker & Diagnostic Director in Hematology.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you'll bring to the role:

• MD or Ph.D OR MD/PhD with minimum of 5 years of correlative science in Oncology, including biomarkers, of which a minimum of 1 years must be in Pharmaceutical industry. MD must have a minimum of 2 years’ experience in development & implementation of patient selection and other correlative strategies for clinical programs and/or oncology clinical trial experience.

• PhD in Molecular Biology, Oncology, Molecular Pathology, Lab Medicine, Life Sciences or

• MSc/MBA with equivalent experience in life sciences, Molecular Biology, Oncology, Molecular Pathology, Lab Medicine

• 3 years industry experience
• 3+ years multi/cross functional leadership experience within an Oncology business unit.
• Expert leadership skills proven in GPT, or in other organizational assignments. Expert skills to facilitate/optimize contribution of team members as individuals and members of cohesive team.
• Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.
• Diagnostic experience is an advantage
• Results driven
Global Drug Development
Research & Development
Full Time
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Global Biomarker Diagnostic Associate Director

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