Principal Scientist; Scientific Director Level)– Nonclinical Drug Safety

Job Summary

We are seeking a Discovery Program Leader (DPL) to represent Nonclinical Drug Safety (NDS) on discovery research teams and in scientific and strategic review meetings focused primarily on immunology and oncology. This position requires exceptional leadership, collaboration, and independence, and a passion to work collaboratively across functions and sites to discover novel medicines that improve the lives of patients. The Discovery Program Leader is responsible for defining and overseeing the NDS strategy for programs in all modalities (including small molecules, peptides, biologics and ADC programs) from Target Identification through to the approval of First-In-Human enabling GLP toxicity studies.

They are responsible for
1) providing risk assessments for targets,
2) de-risking strategies for discovery programs and
3) collaborating with NDS staff at other sites to execute on the appropriate studies to support selection of therapeutic targets, and the identification and development of new drug candidates. The DPL may also serve on development teams with responsibility for defining the GLP toxicology study strategy and execution, and for the non-clinical safety sections of regulatory documents that support clinical trials and worldwide marketing authorization.

In this role you will:
Represent NDS on discovery teams and participate in therapeutic area discovery governance committee reviews. Promote and facilitate creative thinking from target identification/validation through lead optimization in Infectious Disease, Neuroscience, Immunology, Oncology, and/or Cardiometabolic Therapeutic Areas. Be a “drug creator” and promoter of innovative thinking by influencing both cross-site disease area aligned groups, as well as functional area disciplines. Identify and assess potential risks associated with therapeutic targets or development candidates using available literature, internal data, and external information.

The individual may also lead early development teams, informing on preclinical studies to support product development.

PhD in relevant field, DVM, MD degree or equivalent. Minimum 8+ years of demonstrated pharmaceutical industry experience as a non-clinical safety scientist (e.g. Toxicology, Pathology etc.) and/or as non-clinical safety assessment representative to a cross-functional development and/or discovery teams. Demonstrated ability to successfully navigate cross-functional lines and drive team decision making in a matrix organizational structure. Highly dedicated, motivated, resilient, and flexible;

capable of creative problem solving and delivering on goals and objectives in a timely fashion. Excellent team player who can work collaboratively with discovery team members from various functions, other DPLs and scientists responsible for study conduct and portfolio management. Excellent interpersonal skills, able to establish good working relationships within networks of employees of all levels. Excellent communicator who knows when and how to speak up, and appropriately raise issues to stakeholders and to management.

Experience with biopharmaceutical and small molecule pharmaceutical development and/or discovery. Experience with regulatory submissions and responses. Member of pharmaceutical consortia and/or external scientific or professional organizations.

Clinical Safety, Finite Element Analysis (FEA), Good Lab Practices, Immuno-Oncology, Innovative Thinking, Matrix Management, Quality by Design, Regulatory Filings, Regulatory Submissions, Safety Management, Strategic Thinking, Technology Transfer, Toxicology.

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