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Position:
Associate Director-DMPK  

Employer:
Aligos Therapeutics

Description:

About the job

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 of a high-energy, public Research and Development company. We are looking for an enthusiastic Senior Financial Analyst 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.

 

Position Summary/About the Team:

This position will be responsible for leading DMPK scientific strategies for small molecule and oligonucleotides, as a project representative on multi-disciplinary drug discovery and development teams. The position will have high visibility within the company and is expected to contribute directly to the company’s goals and objectives.



Qualifications/Experience:

Essential Functions / Responsibilities:

  • Responsible for day-to-day management of project related activities that includes working closely with nonclinical discovery scientist, clinicians and cross-functional project team members. Will participate as functional representative on discovery/development project teams.
  • Provide strong scientific guidance for candidate selection, develop and drive DMPK strategies for lead optimization and solving ADME-related issue.
  • Design, conduct and interpret in vitro and in vivo DMPK studies. This will include, determining PK parameters for nonclinical studies, 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 for internal and external meetings, both orally and as written reports.
  • Author and review various regulatory documents and interact with worldwide regulatory authorities.   

 

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 and oligonucleotide pharmacokinetics and metabolism with 8 to 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 of supporting regulatory submissions.

 

Preferred Education and Experience:

  • Familiarity with NONMEM, SimCyp and/or Gastroplus PBPK modeling is nice to have.
  • Managerial experience is nice to have. 

 

Physical Requirements:

  • It is expected that the employee is able to sit/stand at a desk and have full use of a computer through its standard input devices (e.g., mouse and keyboard).

 

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.



Location: South San Francisco

Contact: vgohil@aligos.com

Post Date: 6/25/2021 8:59:12 AM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 9/25/2021; Admin Logon
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