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 Director of Clinical Operations will manage a team of clinical operations staff to ensure the effective and efficient execution of all operational aspects of early stage clinical programs initially evaluating multiple investigational drugs for the treatment for chronic hepatitis B. This will include clinical study planning, implementation, data delivery and reporting. This is a highly visible role that interacts with a broad range of functions within an early drug development environment at a small dynamic biotech company.
This position will report to the Head of Clinical Development and will be a member of the department’s management team. The position holder will have an opportunity to shape the future nature of clinical operations activities at a fast-moving company.
Essential Functions / Responsibilities:
- Managing a team of Clinical Operations personnel responsible for implementing clinical development strategy
- Overseeing the development and proactively managing the execution of high quality, clinical studies including the development of detailed timelines and budgets
- Promoting a productive and positive team environment
- Identifying potential program risks and developing mitigation strategies to address them
- Developing best practices for clinical operational activities
- Developing operational strategies for consistent implementation of clinical studies
- Contributing to the development and maintenance and development of quality management systems
- Ensuring a high level of oversight of all service providers engaged in the conduct of clinical development programs
- Partnering with Quality Management to develop and implement quality activities within Clinical Operations including risk management strategies
- Identifying potential trial level risks and developing mitigation strategies to address them
Required Education and Experience:
- BS/MS Degree with 10+ years of relevant progressive clinical trial management experience in the drug development industry with at least 2 years at Director level
- Demonstrated clinical operational track record in successful implementation and completion of clinical trial programs
- Demonstrated an ability to be effective in a matrixed project team environment including all cross-functional aspects of drug development (e.g., preclinical, CMC, regulatory, clinical, quality, etc.).
Preferred Education and Experience:
- Experience of early clinical development, particularly with antiviral or anti-infectious disease compounds is preferred.
Additional Eligibility Qualifications/Competencies
- Strong written and verbal communications skills.
- Able to operate effectively in a multi-disciplinary environment within a small company.
- Strong influencing skills and facilitation skills to be able to effectively engage with key stakeholders within the company.
- Proactive problem solver and be able to promote ideas persuasively and build on the ideas of others in a constructive manner.
- Strong leadership skills and excellent communication skills.
- Strong financial acumen.
- Experience in running international and US based 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 is a supervisory position, and management of one or several subordinates in the Clinical function is expected.
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.
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