Senior Lead, Preclinical Development

Internal Job Title: Senior Expert: Science and Technology (Level 4/GJFA 5)

Position Location: Cambridge, MA, onsite

Job Description:

Technical Research & Development (TRD) is seeking a highly motivated individual to join the discovery pharmaceutics function, Chemical and Pharmaceutical Profiling (CPP), and contribute to the development of discovery compounds. This successful candidate will join an energizing and collaborative research environment working as part of cross functional drug discovery teams in providing a developability assessment of new chemical entities.

The ideal candidate must be capable of working independently to support projects through the preclinical stages by being a core team member of the research teams and providing a developability assessment of small molecules to expedite them into preclinical PK, PD and tox studies via formulation. Additionally, they will recommend physical form and clinical formulation principles based on biopharmaceutical properties to ensure smooth knowledge transfer to early development colleagues. As such, strong competency in physical pharmacy, preclinical formulation development and biopharmaceutics is required to efficiently function in this role and in understanding the physicochemical properties of new chemical entities and implementing formulation strategies to maximize the exposure in preclinical in vivo studies.

The candidate must demonstrate and foster strong team spirit and promote knowledge exchange within and between teams. Furthermore, the candidate should be able to proactively manage the interactions of project related activities between CPP and other departments such as research and pharmaceutical development. The candidate must ensure alignment with other departments and functions and 3rd parties, as appropriate. To accomplish this, the role requires timely communication of overall project information to the appropriate management level via oral and written communication and ensuring that the project team objectives are in alignment with functional objectives.

Your key responsibilities include, but are not limited to:

• Represent TRD as a member of research stage core project teams, contributing to overall project strategy and success.

• Screening of phase appropriate formulations to enable robust in vivo assessment of new compounds and preparation of formulations for use in preclinical in vivo studies and authoring protocols to enable preparation of formulations for use at internal and external formulation labs

• Conduct assessment of new compounds to identify the main risks and develop strategies to mitigate them. Proactively communicate key issues to influence selection of compounds with favorable profiles.

• Basic drug substance characterization by techniques such as XRPD, DSC and TGA, DVS, PLM and UPLC. Assessment of the chemical and physical properties of small molecules, such as solubility, dissolution, particle size and chemical stability

What you will bring to the role:

• Advanced degree in pharmaceutical sciences, chemical engineering, or related scientific field with 10+ years relevant experience in pharmaceutical development or another related field

• Hands on experience with a range of analytical methods used to assess small molecule compound properties.

• Practical experience in the developability and biopharmaceutical assessment of low molecular weight compounds

• The ability to manage multiple parallel activities and deliver results to agreed timelines in a highly dynamic, fast-paced environment with evolving priorities.

• Ability to work both independently and as a core member in multidisciplinary teams.

The salary for this position is expected to range between $114,100 and $211,900 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days,
holidays and other leaves.

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