Associate Director, Biopharmaceutics

About Us

Exscientia is an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting.

Our pipeline demonstrates our ability to rapidly translate scientific concepts into precision-designed therapeutic candidates, with more than 15 projects underway. By designing better drugs, faster, we believe the best ideas of science can rapidly become the best medicines for patients.

The Role

• Were seeking an experienced Associate Director of Biopharmaceutics to contribute to our mission to develop better medicines, faster. In this role you will lead activities related to biopharmaceutics, develop-ability and early global CMC strategy to guide the selection of clinical candidates, drug delivery, and clinical formulation strategies that fit the project team's objectives whilst retaining agility and flexibility for our fast-paced can-do culture. You will build biopharmaceutics capability and scientific understanding and be a crucial link between different parts of Exscientia organisation such as discovery, medicinal chemistry, and early development.
• As Associate Director Biopharmaceutics, you will provide fundamental understanding of in vivo drug product performance and define adequate biopharmaceutics strategies at all stages of development in alignment with the global business strategy. You will be responsible for leading a comprehensive and strategic approach to developing and executing integrated global CMC strategies to fully integrate the deliverables of the CMC development plan within the objectives of the discovery and drug development teams. You will also represent the company with domestic and international regulatory authorities, contractors and corporate partners as needed.
• Please note this is a remote/ hybrid role and occasional travel is required to our office in Oxford, UK (approximately once a quarter), with flexibility to work from home in the UK the remaining time. We are a flexible working organisation and were willing to consider other options which would provide similar contact time with the team.

You will have the opportunity to:

• Manage and lead all Biopharmaceutics deliverables and formulation strategy aspects of late-stage lead optimisation, preclinical and clinical projects at Exscientia, to agreed timelines and budget by interacting with internal and external multidisciplinary teams in a virtual development organisation.
• Applying biopharmaceutics knowledge across projects to support integrated product design, drug delivery and targeting, innovative manufacturing processes, and smart bioavailability and bioequivalence studies, where applicable.
• Apply in-silico physiologically-based biopharmaceutics (PBPK) models to predict in vivo performance of oral formulations and other routes of administration.
• Act as the internal expert when discussing Biopharmaceutics and formulation strategy with our Pharma partners.
• Collaborate with PKPD modellers to integrate and apply the mechanistic understanding of absorption/biopharmaceutics for each drug substance and drug product development.
• Be up to date with emerging regulatory expectations in the field of PBPK absorption modelling and biopharmaceutics and contribute to and review patent applications and regulatory documents to support Submissions.

Requirements

Essential skills:

• PhD with a minimum of ten years in the pharmaceutical industry and 7-9 years of experience in the field of biopharmaceutics, drug absorption/ pharmacokinetics, PBPK modelling, in-silico platforms and/or drug delivery of small molecules.
• In-depth understanding of and experience and expertise in physicochemical and biopharmaceutics profiling and associated techniques (e.g. solubility, in-vitro release, particle characterization etc.), mechanistic PBPK modelling (e.g., Gastroplus, Simcyp), in-silico platforms and application to product design across dosage forms.
• Experienced in managing projects with external CROs and CDMOs/CMOs including all aspects of external vendor selection and management (with demonstrable success working with internal and external partners to meet deliverables).
• Experienced in IND, CTA and preparations for regulatory authority interactions; thorough knowledge of relevant FDA and EMEA regulations.
• Excellent scientific leadership skills, delivering robust scientific contributions to projects with evidence of applying risk-based and value driven approaches for successful delivery.
• A good team player, able to communicate clearly, with the ability to discuss complex ideas in a simple, easy to understand, manner.

Please apply on the below link for a quicker response.

https://lifelancer.com/jobs/view/b9138f97247ec62d45b9d0818b00e7d9