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, pre-IPO Research and Development company. We are looking for an enthusiastic scientist 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.
The (Senior) Clinical Study Manager will report directly to the Head of Clinical Operations and will be responsible for the operational implementation of one or more clinical trials. This individual will be a key member of a small clinical development team that is implementing a number of early stage clinical programs evaluating multiple investigational drugs for the treatment for chronic hepatitis B.
Essential Functions / Responsibilities:
- The development and execution of high-quality, realistic, cross-functional, clinical trial plans using best practice management standards and methodologies
- The identification and selection of Service Providers (SPs) and investigational clinical sites
- The development of Requests for Proposals from Service Provider’s
- The management of Service Providers including training and oversight, and for being the primary point of contact for SPs
- The drafting and coordination of reviews of study-related documents including protocols, informed consent forms, case report forms, monitoring plans, investigator brochures, and clinical study reports
- The development and maintenance of study timelines and study budgets
- The coordination of the review of data listings and oversight of the preparation of interim/final clinical study reports
- Contributing to the development of abstracts, presentations, and manuscripts
- Monitoring and tracking clinical trial progress and upkeep of status update reports
- Identification of program risks and development and implementation of mitigation strategies
- Set up of (e)TMF, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages
- Ensuring GCP compliance and inspection readiness are maintained throughout study conduct
- Performing Sponsor quality oversight of clinical investigational staff and SPs
- Performance of oversight of central laboratories and other ancillary vendors during start-up, conduct, and close-out
- Coordination with CMC regarding drug forecasting and supply of study drug to investigational sites
- Contribution to the development of clinical trial management best practice processes and SOPs
- Contributing to department initiatives to improve the efficiency and effectiveness of the Clinical Operations group
- May be responsible for mentoring less-experienced Clinical Operations staff on the study team
Required Education and Experience:
- A minimum of a bachelor’s degree and/or RN Degree is required.
- A minimum of 5 or more years (7 or more years for Senior CSM) of clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, or contract research organization is required.
Preferred Education and Experience:
- Experience of early clinical development, particularly with antiviral or anti-infectious disease compounds is preferred.
Additional Eligibility Qualifications/Competencies
- Must have excellent teamwork, communication, decision-making and organizational skills plus a thorough knowledge and understanding of FDA and EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- Significant experience of Service Provider selection and management is required.
- The successful candidate must have in depth knowledge of the Code of Federal Regulations related to clinical research, ICH GCP guidelines, and other applicable regulations and practices is required.
- Working knowledge, understanding and application of principles, concepts and practices of clinical research, experimental design and statistical analysis is required.
- Excellent communication, organizational, negotiation and interpersonal skills required.
- Ability to prioritize and handle multiple tasks and to facilitate and resolve cross-functional activities and issues required.
- The successful candidate must be flexible and adaptable to the needs of a small company.
Work Authorization/Security Clearance
- All candidates are expected to have authorization to work in the United States.
- This position may require the management of contractors external to the company.
Position Type and Expected Hours of Work
- This is a full-time position. Expected days and hours of work are Monday through Friday, 40 hours per week.
- This position is located in South San Francisco and may require approximately 10-15% travel.
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.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for their job. Duties, responsibilities and activities may change at any time with or without notice.
This position works in a standard office setting, in a facility that contains laboratory equipment.
Please send your resume to email@example.com