Position Code: 21009-19B
Gossamer Bio is seeking an outstanding scientist to support our drug discovery and IND enabling programs. The focus of the DMPK scientist will be to lead the research ADME team in support of Gossamers drug discovery project teams. As such, an individual with in-depth knowledge and expertise in ADME and PK/PD is essential. This position will collaborate, align and influence cross-functional teams to identify and mitigate key project questions related to PK, metabolism, assessment of DDI risk, support of IND enabling ADME and toxicology efforts in addition to supporting PK/PD studies and human dose projection calculations.
- Coordination of DMPK activities at CRO’s and guide project DMPK activities across multiple phases, including lead discovery, lead optimization and regulatory filings.
- Accountable for developing a cutting-edge infra-structure including in house capabilities, that leverage automation and robotics, design tools, electronic lab note-books and collaborative IT tools.
- Supervise the DMPK team focused on supporting lead optimization and IND enabling programs.
- Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates.
- Responsible for overseeing the analysis, interpretation, integration and reporting of preclinical DMPK data generated both internally and with external vendors.
- Participate in the selection and management of CROs for the conduct of in vitro/in vivo ADME studies, including IND-enabling studies and studies to support clinical development.
- Provide expertise in human PK and efficacious dose prediction of drug candidates using different approaches.
- Author high quality Regulatory documents including INDs, CTAs and other regulatory filings.
- Partner with and support Medicinal Chemistry, Toxicology, Regulatory, Clinical, Project Management and other departments by implementing ADME strategies that meet regulatory requirements and program goals.
Experience & Education
- PhD in Drug Metabolism, Pharmacokinetics, Chemistry or related scientific discipline with a minimum of 8+ years of biotech/pharmaceutical drug discovery and development experience; or BS/MS with 15+ years of experience.
- Ability to plan, organize, and critically assess and/or perform PK/PD data analyses.
- Knowledge of the latest in technological and regulatory advances in the DMPK arena and demonstrate strong interest and expertise in PK and physicochemical properties modeling techniques.
- Strong knowledge of drug metabolism and pharmacokinetics principles.
- Experience in serving as the lead ADME/PK expert on discovery and lead optimization teams.
- Experience in applying DMPK concepts and principles to drug discovery and development.
- Demonstrated capability to mentor junior scientists and manage in a matrix environment.
- Builds strong relationships with peers and partners outside of DMPK to enable high team performance.
- Excellent oral and written communication skills and an ability to influence.
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].