Head of Clinical Bioanalysis, PK Sciences

264,000. That is the number of samples managed by the Global Bioanalytics team in 2018. 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? Are you looking to build and grow your leadership opportunities? As a Global Team Lead of Clinical Bioanalysis in the Translational Medicine PK Sciences Bioanalytical group, you will have the opportunity to make a difference. If you have a collaborative nature, a commitment to teamwork across an organization and a relentless focus on improving patient care we want you to apply. 

In the role, you will lead a group of 8 scientific monitors with overall responsibility for method development, validation, and implementation of immunogenicity/molecular biological assays as primary endpoint and/or safety assays for biologics development, clinical studies and post-marketing studies. You will be responsible for conducting bioanalytical work to a high degree of quality and rigor, ensuring compliance with regulatory guidances, and for the preparation of high quality regulatory submissions. Additionally, you will provide strategic direction and leadership for staff, build strong teams, attract and develop diverse staff. Provides technical oversight of external development and implementation of regulated immunogenicity and molecular biology assays.

In setting the standard for conducting innovative research and helping deliver breakthrough therapies to our patients:

 Your main responsibilities will include but are not limited to:
• Managing the daily operations of a local team of associates responsible for the development and of bioanalytical assays for PK, TK, PD and ADA as well as supporting other new modalities such as oligonucleotides and Cell and Gene therapies platforms.
• Coordinating project support and planning of lab resources and ensuring high quality data delivery within timelines in support of Global BA teams and other stakeholders.
• Providing consultation and technical support for preclinical and clinical Immunogenicity strategy discussions within Global BA and providing data interpretation consistent with current industry and health authority expectations.
• Contributing relevant bioanalytical sections to regulatory and submission document (e.g. IB, CTD.) as needed.

JOB REQUIREMENTS: What you will bring to the role:

Qualifications:

• Ph.D. with minimum of 15 years of bioanalytical or related experience significant and relevant experience in a pharmaceutical, CRO or related industry.
• Previous hands-on experience with the development of ligand binding assays as well as some experience with qPCR techniques and cellular assays preferred (ex. Flow Cytometry assays, Receptor occupancy assays, Cellular Immunogenicity assays).
• Fundamental understanding of immunogenicity assay development and qualification. Ability to assist with LBA method troubleshooting across a variety of platforms. Strong knowledge of integrated immunogenicity data interpretation especially in conjunction with safety/PK/clinical data.
• Evidence of increasing levels of responsibility managing the day-to-day activities of a small group of scientists. 
• Strong interpersonal communication skills and ability to manage in a dynamic, ever-changing working environment.

Why consider Novartis?

817 million. That’s how many lives our products touched in 2018. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? 

We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks. 

Join us and help us reimagine medicine. Our patients are waiting...
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.