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Global Biomarker Diagnostic Director, CAR-T (80-100%*)

Inseriert am: 17.06.2021

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Job ID 303942BR Position Title Global Biomarker Diagnostic Director, CAR-T (80-100%*) Apply to Job

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.



As Global Biomarker Diagnostic Director, you will lead and be responsible for all aspects of the execution of the program’s precision medicine strategy with predominant focus on execution of activities to support decision making and regulatory approval of any Companion Diagnostic (CDx) assays.



Your responsibilities include, but are not limited to:



• Develop the program Precision Medicine strategy aligned to the disease area in support of a global program team (GPT) and lead the precision medicine program team for assay development, molecular epidemiology, and other research-related activities with other internal stakeholders.

• Serve as a core member of the Global program team (GPT) and core member of the Global Clinical Team (GCT) and other teams where implemented

• Establish and maintain partnership with internal stakeholders (global line functions) and external partners (clinical research organizations, Academic Labs, clinical labs and diagnostic partners) for assigned program(s) to drive the implementation of the program’s strategic plan.

• Collaborate with early commercial, quality assurance functions, identify ,validate, partner with external laboratories involved in assays for clinical trials and companion diagnostic development

• Responsible for data generation in studies ensuring consistency with global development strategy within a specific disease area

• Avoid strategic and operational crises by proactively identifying and handling potential risks to the program(s). In case issues cannot be avoided, ensures that they are being resolved employing the full technical and strategic expertise and experience of the organization thus limiting negative impact on the program(s)

• Act as biomarker & diagnostic expert, providing strategic guidance and scientific support for cross-functional goals (Medical Affairs, Commercial and Market Access leads)

• Provide scientific expertise and support to CPO and regional colleagues for product launches and post-launch management related to diagnostic testing as required




Minimum requirements

What you'll bring to the role:



• PhD or MD or MD/PhD preferred, with 5 years’ experience in correlative science and/or companion diagnostics, experience in Oncology, including biomarkers

• Minimum of 3 years industry, or comparable drug development experience within a biotech or pharma environment

• Proven contribution to project goals within a program team, or in other organizational assignments

• Strong interpersonal and communication skills for bridging scientific and business participants and communicating strategy across internal team

• Proven people leadership capabilities

• Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.



Desirable:

• Knowledge of oncology companion diagnostic development is an advantage

• Knowledge in hematological malignancies is an advantage

• Diagnostic or pharmaceutical focused clinical experience is an advantage



*some restrictions to flexible working options may apply and will be discussed at interview if applicable



WHY NOVARTIS?



769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.



We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.



We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!Imagine what you could do here at Novartis!



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:If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: talentnetwork.novartis.com/network Division Global Drug Development Business Unit OHD GDD Location Switzerland Site Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No

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