DMPK Project Specialist, Director

Do you have experience in small molecule Drug Development and an interest in Biotransformation and Drug-Drug Interaction assessment? Are you interested in expanding your role?

The GSK global DMPK organization is looking for a DMPK Project Specialist (Director) to join the Development DMPK Project Specialist group, based in either Philadelphia, USA, Stevenage, UK, or Boston, USA.

The candidate must have an in-depth knowledge of small molecule drug development and a keen interest in understanding biotransformation and drug disposition. In addition, the candidate should have experience in the authoring of regulatory documentation (e.g. Investigator Brochures, briefing documents for regulatory agency meetings and responses to regulatory queries. Working collaboratively with key matrix project team members (i.e. Project Leaders, Safety Assessment, Clinical Pharmacology, DMPK Modelling, Nonclinical regulatory etc.), across different therapeutic areas, 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.

Experience supporting the development of other modalities (e.g. small molecule, ADC, antibody, oligonucleotide therapeutics) is also desirable.

KEY RESPONSIBILITIES

• Provide DMPK input into project strategy and DMPK data interpretation for primarily small molecule Development stage projects (e.g. human metabolism, MIST and DDI strategy)
• 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. A track record in support of multiple projects across different therapeutic areas which may include portfolio responsibilities.
• 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. Put significant effort into training, mentoring and coaching others.
• Sustained record of highly effective collaboration, flexible and courageous thinking at team, department, project and/or portfolio level (or equivalent), leading matrix teams of cross-discipline scientists and coordinating key outputs to drive substantial change within GSK.

Basic Qualifications:

We are looking for professionals with these 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 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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