Hybrid jobs in Belgium (5), Bulgaria (1), Croatia (1), Denmark (6), France (4), Germany (4), Hungary (1), Italy (3), Lithuania (1), Multiple Countries (5), Netherlands (1), Poland (4), Spain (1), Sweden (1), Switzerland (6) and United Kingdom (4).
This position serves as a key role in the effective implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (including
Lead the development and execution of clinical pharmacology strategies for ground breaking small-molecule programs. In this pivotal role, you will directly influence key decision-making processes, support regulatory interactions, and help build a
The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets in development, prepares CMC sections of IND/IMPD, MAA, NDA/BLA as well as assesses global filing strategy for post approval changes.
You will play a key part in driving operational excellence, ensuring compliance, and enabling seamless execution of strategic initiatives - from managing external events and vendor relationships to supporting budgeting processes and global collaboration.
Responsible for leading and coordinating operational activities supporting clinical stage development programs within CNS and rare disease indications, ensuring alignment across clinical supply, external manufacturing, quality coordination and vendor
They will lead and develop the hematology medical team, setting direction and fostering a culture of medical excellence, defining and implementing medical affairs therapeutic area (TA) strategy for hematology, aligned with affiliate and global priorities.
Develop and execute robust global regulatory CMC strategies for marketed biological products throughout their lifecycle. Plan, review, and prepare CMC documentation for marketing authorization maintenance, post-approval variations, and health authority
You will contribute to multi-disciplinary drug development managing and providing an integrated understanding of pharmacokinetics/pharmacodynamics (PK/PD), DMPK properties, and drug interaction (DDI) including model based predictive studies. Manages
It is expected that you will provide regulatory expertise and guidance on European/ROW procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team to ensure an optimal European/ROW regulatory strategy for
In this role, you will be responsible for developing and executing the Technology Strategy | Roadmap in the field of Cell Culture Media and CHO Cell Lines & Processes. This role involves leveraging your expertise to generate and evaluate state-of-the-art
The candidate will serve as the bioanalytical expert for LC-MS and oversees outsourced LC-MS-based assay development, validation and sample analysis by bioanalytical vendors in support of regulated nonclinical and clinical studies for several of the
Own the end-to-end lifecycle of Pharmacovigilance Agreements (PVAs), including development, execution, maintenance, and termination where applicable, along with all associated deliverables. Contribute to strategy setting in collaboration with line
Drive the development of next-generation CHO host platforms for complex therapeutic protein production. Design and generate mammalian expression vectors using state-of-the-art molecular biology and assembly technologies. Oversee phenotypic and molecular
This role will be responsible for driving the management of our TTR amyloidosis franchise. This role will support and challenge country teams in tailoring the global strategy to the regional and local market specifics while maintaining global alignment;
Set the strategic direction to build the statistical and clinical unbiased evidence for all clinical phases (I-III), regulatory submissions, market access and life cycle management; Contribute in collaboration with all scientists in DEV to design the
Provides leadership and oversight for multiple, complex clinical trials and programs, ensuring delivery of high-quality data and regulatory compliance. Spearheads collaboration with internal study teams and vendors to ensure clinical trial delivery meets
Contribute to the design of novel and efficient synthetic pathways for drug substances undergoing clinical development; Conduct and oversee route scouting in laboratory to demonstrate synthetic viability; Use all imaginable chemistry tools and methods to