Position Code: 23132-19B
This position acts as the lead clinical pharmacology analyst for clinical studies at Gossamer. This position is responsible for assigned clinical studies and will be the key expert on all clinical pharmacology analysis supporting assigned projects. This position will work in close collaboration with different functions including Clinical, Biometrics, Medical Writing and Regulatory. The level of this position will depend on the experience and qualification of the candidate.
- Responsible for the data analysis and function support of clinical studies and will manage the clinical study process from protocol development to final study reporting.
- Evaluate and perform hands-on analysis of clinical PK and PK/PD data; authorize and review PK clinical study reports
- Ensure timely and accurate communication of study results and interpretation to Clinical Pharmacology Lead and appropriate internal drug development teams
- Assist preparation of Clinical Pharmacology components of investigator brochures and regulatory submissions.
- May provide PK/PD modeling to support dosing strategies for clinical programs
- Maintain a current understanding of PK literature and methodology
- Ensure appropriate quality of documentation for internal department studies compatible with global regulatory submission requirements
Education & Experience
- BS, MS, PharmD, or PhD with relevant expertise in pharmacokinetics, pharmacology or pharmaceutical science is required; minimum of 2+ years of direct industry experience in conducting clinical PK and PK/PD data analysis
- Experienced in authoring clinical pharmacology sections of CSR and providing clinical pharmacology function support to study teams.
- Knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, drug metabolism, bioanalysis, biopharmaceutics and regulatory affairs.
- Population PK/PD analysis and PBPK modeling experience is a plus
- Experience in working with external CROs and timely delivery of clear, accurate and well written study findings
- Must be experienced and skilled in working with matrix teams.
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].