Position Code: 21065-19B
The Senior Scientist will join the Toxicology group as a project toxicologist to support Gossamer’s pipeline programs. This includes supporting programs from early compound selection, through IND and clinical development. The Senior Scientist will be responsible for coordinating external activities and timelines in collaboration with cross-functional project team members. The Senior Scientist will be responsible for developing and executing toxicology strategies to support lead optimization, interpretation of nonclinical safety studies, and deliver high quality nonclinical submissions. The successful candidate must have the ability to multitask, exhibit strong interpersonal skills, and both oral and written communication skills.
- In conjunction with project team members, including DMPK, Research, CMC, Project Management, Clinical, and Regulatory Affairs, develop toxicology strategies and timelines and provide expert support for lead optimization, candidate selection, IND and clinical development
- Execution of toxicology strategies including study designs, protocols, study monitoring at contract research organizations (CROs), data interpretation, and reporting
- Prepare and present nonclinical safety data to project teams, portfolio management, internal/external partners and/or scientific groups
- Provide strategic advice to project teams and senior management including evaluation of conclusions and potential impact of toxicology results on program and clinical/regulatory strategy
- Coordinate finalization of toxicology reports and manage the written and tabular nonclinical sections of the eCTD
- Support the preparation of US and international regulatory submissions and interactions with health authorities.
- Collaborate on the design of non-GLP investigative and pharmacology studies to support development programs, as needed
- Participate on due diligences for potential in-licensing candidates, as needed
Experience & Education
- Doctorate degree with 6+ years or Masters Degree with 10+ years of applying toxicology in drug discovery and development.
- Biopharmaceutical experience in small molecule drug development and Immunology experience preferred, and DABT certification strongly preferred.
- Familiarity with GLP regulations and ICH/FDA guidelines for the conduct of toxicology studies to support regulatory filings
- Experience working with CROs to enable high quality study reports
- Ability to multi-task and change quickly to changing priorities
- Strong written and oral communication skills and a track record of achievement in publications. Will work collaboratively with multifunctional teams and relentlessin pursuing success
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest to [email protected].