Clinical Trial Leader II
Novartis Institutes for BioMedical Research
Nov Hltcr Shared Services Ind
Research & Development
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:
• Responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial related documents and processes which reside in other line functions; obtain approval from internal review boards. In collaboration with the Medical Lead, accountable for delivery of Clinical Study Reports, ensures consistency, quality, and timely publication of studies across assigned TCO projects.
• Lead and matrix manage the global multidisciplinary CTT with minimal supervision to ensure all trial deliverables are met according to timelines, budget, and resource requirements; speaks up against unrealistic timelines. Energizes CTT to adhere to global performance and quality standards: chair CTT meetings, report to program and TCO management on study progress and issues with their resolution plan. Engages the input of line functions at the appropriate time. Leads trial level interactions with country Global Clinical Operations (GCO) and other relevant functions including Integrated Medical Safety and Global Clinical Supply (GCS).
• In collaboration with the Medical Lead, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
• Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
• Accountable for the development, management and tracking of trial budget working closely with Vendor Management, with Clinical Trial Budget Managers and TCO Global Program Managers.
• Accountable for accuracy of trial information in all trial databases and tracking systems. Assess resource needs with program and TCO management to ensure appropriate line function allocation. Sits on Early Program Team (EPT) to contribute to program strategy.
• Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors; manage interface with external vendors in cooperation with the CRO Management Department. This also includes the set-up, logistics, documentation and clinical supplies needed for the clinical trial(s).
• Participate in the hiring, on-boarding, and training of new staff. Mentor junior associates. Responsible for implementation of best practices and standards for trial management, including sharing lessons learned. Represent TCO ClinOps on initiatives; serve as Subject Matter Expert as appropriate.
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.
• ≥ 5 years technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
• Advanced knowledge of oncology and/or hematology, OR experience in early clinical development.
• Hands-on experience in patient data review, cleaning and analysis required.
• Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote).
• Proven experience in developing effective relationships with key investigators.
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: https://talentnetwork.novartis.com/network
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