Preclinical Development Leader, Pharmacokinetics, Dynamics and Metabolism - Belgium, United States
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- Within the EU team of Preclinical Project Development, we have an open position for an experienced PCDL with a background in pharmacokinetics (PK), metabolism and PK/PD.
- The PCDL will provide scientific and strategic leadership for all aspects of the non-clinical development plan for assigned products, with a focus on small molecules in early development up to post-marketing. The PCDL represents Preclinical Development & Safety (PD&S) in Compound Development Teams (CDT) and is the interface between the CDT, PD&S functional and senior management.
- You will provide scientific and strategic leadership to projects, mainly in the therapeutic areas of Neuroscience and Infectious Diseases, focusing on small molecules in early and late development up to post-marketing.
- You will lead the development and maintenance of the PD&S strategic plan as well as the operational project plans (activities, resource requirements, budget and timelines) for assigned compounds.
- You represent PD&S in Compound Development Teams and assure optimal design and execution of nonclinical safety strategies.
- As key contributor to the selection and timely development of new compounds, you work in close collaboration with therapeutic areas, CMC, clinical pharmacology, clinical and regulatory functions.
- You are responsible for the integrated Safety, PK and PK/PD assessments in close collaboration with the functional experts.
- You represent PD&S at internal and external review committees, also including Global Health Authority meetings.
- You lead a preclinical sub-team of functional experts to move projects forward.
- You identify potential safety, PK and PK/PD related issues impacting drug development, design and implement mitigation plans and guarantee the overall quality of the project.
- You lead the preparation of regulatory documents (i.e., IND, NDA, MAA, CTD and responses to regulatory agencies) prepared by the preclinical sub-team.
- Keep informed on the existing and evolving preclinical guidelines.
- You take a lead position in the preclinical review of potential in-license candidates.
- In conjunction with functional management, you plan and provide developmental opportunities for preclinical sub-team members to increase efficiency, reassure job satisfaction, and ensure training for potential advancement.
- You have a PhD degree in Pharmaceutical Sciences or Pharmacology or confirmed equal experience, with a deep understanding of ADME processes and PK/PD, and general knowledge of the functional disciplines within PD&S is required.
- A minimum of 5 years of experience as a (Pre)clinical Scientist in pharmaceutical Compound Development Teams (including preparation of functional project plans, coordination of NDA/MAA/CTD filings and interacting with regulatory authorities) is required, next to 7-10 years of PK experience.
- Experience in interpretation of PK properties and PK/PD data relevant to drug development.
- Organizational, planning, analytical skills and the leadership skills needed in the completion of deliverables to the Compound Development Team.
- Excellent partnering and decision-making skills, the ability to perform effectively in a constantly changing environment, to bring perspectives and approaches together in novel and unique ways, and create and suggest new ideas for projects/programs.
- Excellent oral and written communication skills and ability to clearly and concisely present and communicate nonclinical safety results and their impact to various audiences, including internal boards, Health Authorities and investigators.
- Ability to empower people, discover and develop potential and challenge in a positive manner where necessary.