DMPK Project Specialist Director
4 weeks ago
We are seeking a highly skilled DMPK Project Specialist Director to join our team at GSK. As a key member of our global DMPK organization, you will be responsible for designing and delivering the DMPK strategy to ensure project progression from FTIH through to regulatory filing, impacting the drug label and successful medicine launch.
Key Responsibilities:- Provide DMPK input into project strategy and DMPK data interpretation for primarily small molecule Development stage projects.
- Efficiently manage your time and project requests and be accountable for DMPK deliverables to ensure effective support of your projects.
- Influence Project Teams and Research Units from both strategy and scientific perspective.
- Ensure that translational modelling approaches are used to define the DDI potential/risk assessment to influence the clinical development plan and strategy.
- Implement best practices and share insight across the Development DMPK Specialists group to help drive and embed strategic direction.
- Develop and maintain excellent working relations with key matrix partners on Development project teams, to ensure strategic alignment and optimal collaboration and communication.
- Responsible for coordinating and delivering high-quality DMPK contributions to regulatory documents for the projects you support.
- Actively support cross DMPK initiatives as a representative from the Project Specialists group to drive DMPK science and operations within GSK.
- Leader/coach/mentor of other project representatives expressing interest in developing drug development skills and experience.
- MSc or BSc Degree with 10+ years in a field relevant to DMPK (e.g., Pharmacology, Biochemistry, Pharmacokinetics or Drug Metabolism).
- PhD with 7+ years in a field relevant to DMPK (e.g., Pharmacology, Biochemistry, Pharmacokinetics or Drug Metabolism).
- PhD in a field relevant to DMPK (e.g., Pharmacology, Biochemistry, Pharmacokinetics or Drug Metabolism) with 7+ years drug development experience.
- DMPK Development Project Representation experience in small molecules with expertise in Biotransformation (e.g. human metabolism/MIST) and Drug-Drug Interaction assessment.
- Experience, understanding and proven track record in the preparation of regulatory documentation and interactions with regulatory agencies.
- Demonstrated ability to develop and maintain strong working relationships with peers and across matrix Project Teams.
- Excellent communication skills. strategic and learning agility, and readily move between scientific and strategic issues.
- Ability to manage project resources and budgets.
- An enthusiastic collaborator with a proven track record of building relationships and supporting high-performing teams from multiple disciplines.
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DMPK Project Specialist Director
2 days ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeDMPK Project Specialist Director RoleAt GSK, we're committed to uniting science, technology, and talent to get ahead of disease together.We're seeking a highly skilled DMPK Project Specialist Director to join our Development DMPK Project Specialist group, based in either Philadelphia, USA, Stevenage, UK, or Boston, USA.Key Responsibilities:Provide DMPK input...
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DMPK Project Specialist Director
3 weeks ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeJob Title: DMPK Project Specialist DirectorWe are seeking a highly skilled DMPK Project Specialist Director to join our team at GSK. As a key member of our Development DMPK Project Specialists group, you will be responsible for designing and delivering the DMPK strategy to ensure project progression from FTIH through to regulatory filing, impacting the drug...
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DMPK Project Specialist Director
3 weeks ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeJob Title: DMPK Project Specialist DirectorWe are seeking a highly skilled DMPK Project Specialist Director to join our team at GSK. As a key member of our Development DMPK Project Specialists group, you will be responsible for designing and delivering the DMPK strategy to ensure project progression from FTIH through to regulatory filing, impacting the drug...
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Stevenage, Hertfordshire, United Kingdom GSK Full timeJob Title: DMPK Project Specialist DirectorWe are seeking a highly skilled DMPK Project Specialist Director to join our global DMPK organization. As a key member of our team, you will be responsible for designing and delivering the DMPK strategy to ensure project progression from First-in-Human (FIH) through to regulatory filing, impacting the drug label and...
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DMPK Project Specialist Director
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Stevenage, Hertfordshire, United Kingdom GSK Full timeJob Title: DMPK Project Specialist DirectorAbout the Role:We are seeking a highly skilled DMPK Project Specialist Director to join our global DMPK organization. As a key member of our team, you will be responsible for designing and delivering the DMPK strategy to ensure project progression from FTIH through to regulatory filing, impacting the drug label and...
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DMPK Project Specialist Director
3 weeks ago
Stevenage, Hertfordshire, United Kingdom GSK Full timeJob Title: DMPK Project Specialist DirectorAbout the Role:We are seeking a highly skilled DMPK Project Specialist Director to join our global DMPK organization. As a key member of our team, you will be responsible for designing and delivering the DMPK strategy to ensure project progression from FTIH through to regulatory filing, impacting the drug label and...
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