Essential Functions / Responsibilities:

• Responsible for strategic and scientific leadership within the department. Will regularly interacts with senior executives of the company to align and execute discovery and development projects.
• Lead DMPK as a functional representative on discovery and development project teams.
• Work closely with nonclinical discovery scientists, clinicians, and cross-functional development project team members.
• Guide discovery project teams for candidate selection, develop and drive  DMPK strategies for lead optimization, and solving ADME-related issues. Design, conduct and interpret in vitro and in vivo DMPK studies. Responsible for determining PK parameters for nonclinical studies using WinNonlin and assist with the application of modeling approaches (in silico, PK, PBPK) to support human pharmacokinetics and dose predictions, quantitative risk assessment of drug-drug interactions.
• Manage and outsource GLP bioanalysis for nonclinical and clinical studies. Monitor methods development, validation, sample analysis, and review and approve reports.
• Generate, analyze and present data at internal and external meetings, both orally and as written reports.
• Author and review various regulatory documents and interact with worldwide regulatory authorities.
• Manage junior scientists and DMPK budget, decide outsourcing strategies and participate and define future growth strategies for the department.

 

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

 

Required Education and Experience:

• Ph.D. or Pharm D. in Pharmacokinetics, Pharmaceutical Sciences, or related field with a specific focus on small molecule pharmacokinetics and metabolism with 12+ years of relevant industry experience.
• Extensive understanding of DMPK principles. 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.
• Proven skills in pharmacokinetic data analysis using Phoenix WinNonlin.
• Knowledge of GLP, GCP, drug development, and regulatory guidelines is required.
• Proven track record for managing budgets and people.

 

Preferred Education and Experience:

 

• Familiarity with NONMEM, SimCyp, and/or Gastroplus PBPK modeling.
• Experience in oligonucleotide drug development nice to have. 

 

EEO Statement:

Aligos Therapeutics, Inc. is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation can be directed to sstakes@aligos.com.