DMPK Project Specialist Director
4 weeks ago
We are seeking a highly skilled DMPK Project Specialist Director to join our global organization. The ideal candidate will have a strong background in small molecule drug development and a keen interest in biotransformation and drug-drug interaction assessment.
The successful candidate will be responsible for designing and delivering the DMPK strategy to ensure project progression from First-in-Human through to regulatory filing, impacting the drug label and successful medicine launch.
The DMPK Project Specialist Director will work collaboratively with key matrix project team members across different therapeutic areas, providing DMPK input into project strategy and data interpretation for primarily small molecule development stage projects.
Key Responsibilities:
- Provide DMPK input into project strategy and data interpretation for primarily small molecule development stage projects.
- Manage project resources and budgets to ensure effective support of projects.
- Influence project teams and research units from both strategy and scientific perspectives.
- Ensure translational modeling approaches are used to define DDI potential/risk assessment to influence clinical development plans and strategies.
- Implement best practices and share insights across the Development DMPK Specialists group to drive 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 supported projects.
- 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.
Why You?
We are looking for professionals with the following required skills to achieve our goals:
- 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).
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- 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 the ability to 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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