Position Code: 21052-19B
This position participates as a member of the preclinical DMPK team and is responsible for developing and executing PK-PD modeling and simulation (M&S) strategies in a collaborative environment with colleagues in translational, regulatory, safety, and preclinical and clinical pharmacology. This individual will apply state of the art M&S methodologies to support lead optimization, clinical candidate selection, FIH and later stage clinical dose selection.
- Develop/apply state of the art PK-PD modelling techniques to guide advancement of drug candidates across development phases (discovery through early clinical development).
- Initiate and monitor outsourced M&S activities as required.
- Actively participate as PK/PD lead on project teams developing small molecule immunologically focused therapies.
- Contribute to regulatory documents (e.g. IND, IMPD, IB) and attend meetings with regulators as required.
- Participate along with diligence team colleagues in the evaluation of in-license opportunities.
Experience & Education
- PhD, PharmD in Pharmaceutical sciences, Pharmacology, Toxicology or related discipline.
- At least 5 years of hands-on experience with development and application of M&S in a drug-development environment.
- Expertise in a specific therapeutic area and ability to demonstrate successful application of M&S tools in that area.
- Expert user of NONMEM, Phoenix-NLME, R/S-Plus or related software with requisite programming skills.
- Demonstrated skills in development of novel modeling approaches that incorporate factors such as receptor affinity, binding kinetics, and diurnal flux in response.
- Hands-on experience with PBPK model development and implementation is a plus.
- Publication record highlighting application of original PK-PD modeling strategies to guide advancement of drug candidates from discovery through early clinical development.
- Excellent leadership and written/oral communication skills with ability to lead team through influence and collaboration.
- Familiarity with regulatory guidance/expectations applicable to M&S.
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].