Associate Director, Biopharmaceutics

Role Summary

The Associate Director, Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of drug products during formulation development and the drug product life cycle, including interpretation of relevant dissolution data. The scope includes small molecules and biologics/biosimilars, simple and complex formulations within Organon’s general medicines portfolio as well as early development pipeline assets. The position serves an important role in the preparation of biowaiver requests for manufacturing site changes or active pharmaceutical ingredient or excipient supply source changes and/or assessment of associated bioequivalence requirements for the general medicines portfolio of products marketed worldwide.

The Associate Director, Biopharmaceutics 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 Associate Director, Biopharmaceutics will be the primary author for module 2.7.1 for global regulatory submissions.

Responsibilities

• Provide support for the Biopharmaceutics Lead on early clinical development programs to ensure optimal formulation development through assessment of pharmacokinetic performance of a given compound in context of relevant formulation, manufacturing or source of supply changes.
• Provide support for biowaiver and/or assessment of bioequivalence requirements for formulation or manufacturing site changes for the general medicines‚Äô portfolio.
• Design bioavailability/ bioequivalence study synopsis for primary and global markets. Interpret study results and review study protocol and study report as the biopharmaceutics and pharmacokinetic expert
• Identify formulation-related considerations and critical in-vitro attributes which can support predicting in vivo performance during due diligence evaluation.
• Contribute to scientific communications, publications and internal knowledge-sharing events.
• Contribute to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other cross-functional activities, as needed.
• Support interactions with Health Authorities, including meetings and submission preparation, as appropriate.
• Support the Biopharmaceutics Lead in effective engagement with regulators, scientific leaders, and clinical stakeholders, as needed.

Qualifications

• PhD or equivalent degree in pharmaceutics, pharmaceutical sciences, biopharmaceutics, or related discipline.
• Minimum of 3 years of experience in the pharmaceutical or biotech industry.
• Demonstrated technical and scientific knowledge of pharmacokinetics, formulation development and biopharmaceutics, and clinical pharmacology a discipline to facilitate clinical development of drug candidates.
• Working knowledge of early clinical development and clinical pharmacology-, modeling- and bioanalytical-related regulatory guidelines and GxP requirements.
• Regulatory experience including the preparation of submission modules, briefing books and/or product labeling.
• An effective communicator and exemplifies collaboration, integrity, and respectful interactions with Organon personnel as well as external stakeholders.
• 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.
• Experience with management and oversight of vendors responsible for supporting various outsourced research activities.

Preferred Experience And Skills

• Experience in Women‚Äôs Health therapeutic area is preferred.