Location: Japan - Osaka
Salary: 11000000 - 14000000 JPY
Job Function: Clinical Development
Reference: JO-180323-150113
Industry: Life Sciences & Healthcare
Sub-Industry: Pharmaceuticals

• Independently representing CS in global project teams, if appointed as CPL leading global CS team and directing /coordinating the early clinical team (until D6) or contributing to clinical teams (after D6), respectively
• If appointed as CPL Independently creating, updating and implementing the CS development plan and presenting it on decision-making committees within the company
• Representing CS externally, e.g. in meetings with authorities, ethics committees and key opinion leader meetings.
• Providing medical as well as clinical pharmacological advice and expertise to design, plan, execution and evaluation of clinical pharmacological studies in close collaboration with the study teams
• Independently inspecting, evaluating and reporting new results within the context of development projects
• Drawing consequences from new results/critical processes, adapting the project plan by implementing appropriate measures to avert risks within the context of the drug development project
• Actively participating in specialist conferences, seminars/relevant educational events and taking into account the state of scientific knowledge and publications, local and international authority guidelines / requirements and in-house regulations (e.g. SOPs)
• As CPL, being responsible for coordinating of all CS activities related to preparation and submission of dossiers (NDA) and a state-of-the-art label
• Being independently responsible for content and timely provision of clinical pharmacological documents such as IB, IMPD, protocols, PSUR reports, study protocols, IND documents as well as publications.
• Independently providing medical and clinical pharmacology expertise in due diligences of potential in-licensing projects and in out-licensing activities
• Networking with in-house and external experts as well as key opinion leaders, academic institutions and contract research organizations
• Closely cooperate with other CS functions such as Pharmacokinetics, Global Biomarker, CS Operations and Experimental Medicine, as well as across functions with in-house and external project partners
• May provide medical expertise for specific studies (first in man, phase 1 studies with special pharmacodynamic methodology), if applicable at the location, in close collaboration with CS Operations group