Clinical Bioanalysis Monitor
Location
Andhra Pradesh | India
Job description
About the role
PK Sciences (PKS) offers you this opportunity to make an impact, where 450 projects are straddling discovery through development. PKS is a global organization of about 300 associates, situated within Translational Medicine (TM), in Novartis Institutes of Biomedical Research (NIBR). It is an enterprise organization, unique within pharmaceutical industry, where one can work across both NIBR (Research) and the Global Drug Development (GDD) organizations to apply the scientific knowledge of pharmacokinetics, pharmacodynamics, metabolism and clinical pharmacology in advancing the drug candidates from discovery and clinical development through approval and beyond. Novartis portfolio consists of projects using several therapeutic modalities including small molecules, biologics, gene therapy and cell-based therapies. We are active in multiple therapy areas like Oncology, Autoimmune Diseases, Neuroscience, Musculoskeletal Diseases, Ophthalmology, Respiratory, Cardio-metabolic and Infectious diseases. We collaborate across scientific and organizational boundaries, with a focus on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.
Your responsibilities include, but are not limited to:
• Manage all aspects of assay outsourcing at CRO which includes, contract review, assay development, validations in support of clinical trials for biologics . Coordinate and monitor PK, PD, anti-drug (ADA) and neutralizing antibodies (nAb) assay analysis activities during clinical trials ensuring accurate and timely data delivery.
• Support emerging new modalities such as oligonucleotides and Cell and Gene therapies platforms. Act in the liaison between clinical teams and CROs, be a representant for clinical outsourced biologics to ensure alignment of study objectives, timelines, and deliverables.
• Act as scientific leaders with our CRO partners; focusing on the fundamental science providing bioanalytical assays that answer emerging scientific questions during trials.
• Coordinate project support and planning of lab resources, ensuring high quality data delivery within timelines in support of global Bioanalysis teams and other stakeholders
• Contribute to the clinical bioanalytical strategy considering state-of the art technology and current health authority guidelines.
• Review and interpret PK, PD, and immunogenicity data, providing insights and recommendations to support clinical development strategies. Provide technical and scientific oversight of external development and implementation of regulated immunogenicity and molecular biology assays.
• Provide consultation and technical support for clinical Immunogenicity strategy discussions within Global Bioanalysis, and data interpretation consistent with current industry and health authority expectations.
• Contribute to relevant bioanalytical sections to regulatory and submission documents (e.g. IB, CTD, BLA, ISI). Stay updated with the latest scientific advancements and industry trends related to PK, PD, and ADA analysis for biologics
Role Requirements
• Ph.D. Life Science or Master’s degree in a relevant scientific discipline. Significant (e.g. 5 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 knowledge to the global Bioanalytical team, internal and external stakeholders. You thoroughly understand the industry landscape, Health Authority expectations, and bring scientific innovation and influence
• Experienced in writing and supporting others contributing to the bioanalytical sections of regulatory and submission documents. Hands-on experience developing ligand binding assays. Excellent project management skills, with the ability to prioritize and multitask effectively. Strong analytical and problem-solving skills, with a keen attention to detail. Excellent communication and interpersonal skills, enabling effective collaboration with internal and external stakeholders.
• Experience working in a cross-functional team environment. 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
• Some experience with qPCR techniques and / or cellular assays is helpful (e.g. Flow Cytometry assays, Receptor occupancy assays, Cellular Immunogenicity assays). 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 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.
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Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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