Director - DMPK
Aligos Therapeutics, Inc. is a biotechnology company located in South San Francisco, California that is developing novel medicines to treat liver diseases in virology, inflammation/fibrosis and oncology. Aligos is pursuing the development of both oligonucleotide-based and small molecule therapeutics, each addressing major commercial market opportunities.
At Aligos, our science is the key to our success, and to improving patients' quality of life. Our pipeline of developing novel compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the area of liver diseases. This is an exciting opportunity to become an early employee a high energy pre-IPO Research and Development company. We are looking for an enthusiastic person who understands and appreciates the entrepreneurial environment of a “start-up” and who is willing to do what it takes to contribute to the success of the company.
This position is responsible for providing DMPK expertise for new chemical entities as a project representative on multi-disciplinary drug discovery and development teams. The candidate will work closely with nonclinical discovery scientist, clinicians and cross-functional project team members. Responsibilities include guiding discovery project teams for candidate selection, developing and driving DMPK strategies for lead optimization and solving ADME-related issue, designing and interpreting in vitro and in vivo DMPK studies. Responsibilities also includes determining PK parameters for nonclinical and clinical studies using WinNonlin and assisting with the application of modeling approaches (in silico, PK, PBPK) to support human pharmacokinetics and dose predictions, quantitative risk assessment of drug-drug interactions, monitoring of GLP bioanalysis, and CRO management. To support GLP studies, this position is responsible for selecting qualified CROs for bioanalysis, monitor method development, validation, sample analysis and reviewing and approving reports. As compounds progress into clinical development, this person may be responsible for the clinical pharmacokinetic aspect of clinical trials. The candidate will be required to generate, analyze and present data, both orally and as written reports, author and review various regulatory documents and interact with worldwide regulatory authorities. As part of management duties, the candidate will be responsible for maintaining the budget. This position may have direct report(s).
Qualifications and requirements:
- PhD or Pharm D. in Pharmacokinetics, Pharmaceutical Sciences, or related field with a specific focus on small molecule pharmacokinetics and metabolism with 10+ years of relevant industry experience.
- A proven track record of supporting drug discovery and development as a functional representative on multidisciplinary project teams, authoring regulatory documents, supporting worldwide regulatory filings and interactions.
- Extensive understanding of DMPK principles. Proven skills in pharmacokinetic data analysis using Phoenix WinNonlin. Familiarity with NONMEM, SimCyp and/or Gastroplus PBPK modeling is nice to have.
- Knowledge of GLP, GCP, drug development and regulatory guidelines is required.
- The ability to work independently, excellent interpersonal and organizational skills, excellent oral/written communication, proven track record of teamwork, ability to multi task and prioritize to delivery results within tight timelines is a must.
- This position may require <15% of time for travel.