348975BR
Jul 22, 2022
Switzerland

Job Description

264,000 +: the number of samples managed by the Global Bioanalytics team in 2021. Do you want to join a team recognized in 2018 with a Novartis Institutes for BioMedical Research Team Award for their support of a critical FDA registration?

As the Team Lead for Clinical Bioanalysis in the Translational Medicine PK Sciences Bioanalytical group, you will make a difference.
• Provide strategic direction, leadership and operational management to your group of ~8 senior scientific monitors. Projects are based in Switzerland and the US.
• Overall responsibility for method development, validation, and implementation of immunogenicity and pharmacokinetic assays as endpoints and/or safety assays for biologics development, clinical studies and post-marketing studies
• Lead clinical bioanalytical work to a high degree of quality and rigor, ensuring compliance with regulatory guidance and the preparation of high quality regulatory submissions

Your responsibilities include:
• Shape how your team interacts as scientific leaders with our CRO partners; focusing on the fundamental science helping our external partner outcomes be as good as possible. Your team is responsible for the development and validation of bioanalytical assays for PK, TK, PD and ADA, and support other new modalities such as oligonucleotides and Cell and Gene therapies platforms
• Coordinate project support and planning of lab resources, ensuring high quality data delivery within timelines in support of global Bioanalysis teams and other stakeholders
• Provide technical oversight of external development and implementation of regulated immunogenicity and molecular biology assays.
• Provide consultation and technical support for preclinical and clinical Immunogenicity strategy discussions within Global Bioanalysis, and data interpretation consistent with current industry and health authority expectations
• Contribute relevant bioanalytical sections to regulatory and submission documents (e.g. IB, CTD)


This role can be based in either Basel Switzerland or Cambridge USA.

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:
• Ph.D. Life Science or Chemistry
• Significant (e.g. 8 years+) post-PhD relevant experience from an international pharmaceutical company or CRO with evidence of increasing levels of responsibility
• Subject matter expert / extensive clinical bioanalytics, bringing scientific leadership to your team, internal and external stakeholders. You thoroughly understand the industry landscape, Health Authority expectations, and bring scientific innovation and influence
• Previous success line managing and developing a team of experienced PhD Scientists with your supportive, coaching, servant-leadership approach
• Experienced in writing and supporting others contributing to the bioanalytical sections of regulatory and submission documents
• Hands-on experience developing ligand binding assays
• Fundamental understanding of immunogenicity assay development and qualification, used to assisting with LBA method troubleshooting across a variety of platforms. Strong knowledge of integrated immunogenicity data interpretation especially in conjunction with safety/PK/clinical data
• Advanced/business-level oral and written English

Preferred
• Some experience with qPCR techniques and / or cellular assays is helpful (e.g. Flow Cytometry assays, Receptor occupancy assays, Cellular Immunogenicity assays)

Approach and working style
We want an authentic you. Here are some traits we think are important in this position
• Strategic thinker with advanced stakeholder management: you have strong communication skills (verbal, written and presentation) and have influence because of your ability to clearly present complex issues and straightforward solutions
• Excellent interpersonal skills: used to successfully developing effective, collaborative, diverse internal and external relationships, you influence across different nationalities, ethnicities, languages and thinking styles
• A pragmatic, thoughtful, curious, innovative and entrepreneurial approach, used to successfully managing ambiguity with resilience and enthusiasm, responding constructively to challenging new ideas and input

Why consider Novartis?

766 million. That’s how many lives our products touched in 2021 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

Imagine what you could do at Novartis!

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: https://talentnetwork.novartis.com/network

We are Novartis. Join us and help us reimagine medicine.
NIBR
Translational Medicine
Switzerland
Basel
USA
Research & Development
Full Time
Regular
No
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348975BR

Clinical Bioanalysis Team Lead, PK Sciences Assoc. Director (80-100%)

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