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Author and review clinical and regulatory documents such as Study Protocols, ICFs, CSRs, IBs, Paediatric Investigation Plans, Briefing Books, Requests of Product Specific Waivers, applications for Orp...
Develop a clinical strategy and design a protocol for the product, taking into account current medical practice, regulatory requirements, business needs as well as the competitive environment
Assess the non-clinical safety profile of drug candidates (small molecules to complex biological products) from target assessment to registration and participate in early compound selection
Responsible for the overall toxicology/preclinical safety strategy for assigned projects (small molecules & biologics)
Responsible for the overall toxicology/preclinical safety strategy for assigned projects (small molecules & biologics)
Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology - hematology) taking into account current medical practice and unmet needs; advances in both biological...
Lead the supply chain and vendor management team including direct line management of supply chain and logistics specialists
Lead the supply chain and vendor management team including direct line management of supply chain and logistics specialists
Lead the supply chain and vendor management team including direct line management of supply chain and logistics specialists
Define, implement, and monitor scouting strategies to ensure a sustainable in-licensing deal flow in Oncology and Antibiotics.
Define, implement, and monitor scouting strategies to ensure a sustainable in-licensing deal flow in Oncology and Antibiotics.
The Clinical Scientist & Medical Writer Group Head (CS&MW GH) contributes to the development (from First in Human to Phase III) of promising molecules into innovative drugs in the Oncology and Antibio...
Responsible for defining the Global Regulator Affairs strategy (FDA, EMA, China, Japan, etc.) for assigned projects and lead its implementation.
Support the RA core-team representative in the definition and implementation of the regulatory strategy for assigned projects. You might also act as the RA core-project team representative for selecte...
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