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Director, Pharmacometrics

USA - Pennsylvania - Plymouth Meeting

Job Description

The Position

**This position can be 100% remote in the US**

The Director, Pharmacometrics Lead is responsible for devising the program-level modeling and simulation strategy and providing oversight thereof. The responsibility includes identification of the appropriate modeling vendors (fit-for-purpose) and serving as the point of contact, working with procurement and vendor management to facilitate contracting and onboarding of modeling vendors, providing oversight of the modeling process and coordinating appropriate cross-functional discussions, and review of the technical aspects of modeling efforts and modeling reports. 

The Pharmacometrics Lead will also be responsible for contributing to and reviewing clinical modules for regulatory submissions, contribute the authoring and review of Investigator Brochures, INDs, briefing books and other regulatory documents, as applicable. The Pharmacometrics Lead will be the primary author for the description of modeling summaries and provide interpretation thereof in module 2.7.2 for regulatory submissions.

Responsibilities

  • Serve as the Pharmacometrics Lead on early clinical development programs and work in close collaboration with ADTs to develop and implement early clinical development plans that 1) incorporate model-informed drug development (MIDD) approaches and leverage principles of exposure-response to optimize dose selection and confirmation of the therapeutic dose and 2) provides a comprehensive assessment of the pharmacokinetic profile of a given compound, including population pharmacokinetic (PopPK) assessments.

  • Develop high-quality modeling and simulation strategy and content: author/review/approve modeling and simulation analysis plans and outputs, interpretation, and presentation of key findings.

  • Participate in interactions with Health Authorities, as appropriate.

  • Participate in the translational aspects of the strategy and development of the Organon product portfolio, in line with Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and relevant Organon Standard Operating Procedures (SOPs).

  • Engage and communicate effectively with regulators, scientific leaders, and physicians, as needed.

Required Education, Experience and Skills

  • PhD or equivalent degree in pharmaceutics or related sciences.

  • Exemplifies leadership qualities including effective communication and collaboration, integrity, and respectful interactions with Organon personnel.

  • Excellent organizational and interpersonal skills.

  • Ability to process and articulate complex ideas in a manner that can be clearly communicated to less technically trained individuals.

  • Ability to prioritize and focus on important data and considerations to drive results and provide solution-oriented recommendations with an appropriate scientific rationale to address development challenges.

  • Ability to connect seemingly disparate datum or concepts to provide development insights and facilitate strategic planning.

  • A minimum five years of experience in the pharmaceutical or biotech industry with in-depth knowledge of pharmacokinetics, pharmacometrics, …

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