- 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
- Will be responsible for managing, mentoring and/or providing oversight for less-experienced Clinical Operations staff
- Will be responsible for helping to plan and implement professional development activities for any assigned team members
- A minimum of a bachelor's degree and/or RN Degree is required.
- A minimum of 10 or more years of clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, or contract research organization is required.
- Prior experience of management and supervision of clinical operations personnel required
- Experience of early clinical development, particularly with antiviral or anti-infectious disease compounds is preferred.
- The candidate 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.
- Experience in contributing to or establishing clinical operations staff training programs
- Experience of partnering with Quality Management to support the development and maintenance and development of quality management systems
- Demonstrated ability to identify potential trial level risks and develop effective mitigation strategies to proactively address them
- Significant experience of Service Provider selection and management is required.
- Strong working knowledge, understanding and application of principles, concepts and practices of clinical research 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.
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Director, Clinical Operations - South San Francisco, United States - Aligos Therapeutics, Inc.
Description
About Aligos:
Ready to make a difference in the lives of patients all around the world? As a leading clinical-stage biopharmaceutical company, that's our top priority.
Our team of respected scientists use their decades of experience to build cutting-edge pipelines of transformative treatment options that change lives.
We do this by utilizing our proprietary oligonucleotide and small molecule platforms to develop novel therapeutics that address critical unmet needs in liver and viral diseases-such as NASH, COVID-19 and Chronic Hepatitis B.
With three compounds already in the clinic and a diverse portfolio of assets in a variety of indications, we are poised for growth and excited for what comes next.
At Aligos, you'll have an opportunity to pursue your passion among the best in the industry. It's a place where you'll be challenged, supported, and inspired. A highly-collaborative, fast-paced work environment where we honor accountability, transparency, and diversity.Join us for your next challenge.
Learn more about the opportunities waiting for you at Aligos.
Position Summary/About the Team:
The Director of Clinical Operations 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, NASH, and SARS-Cov2.
Essential Functions / Responsibilities:
Required Education and Experience:
Preferred Education and Experience:
All candidates are expected to have authorization to work in the United States.
Supervisory Responsibility
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. Tuesday through Thursday are on site in SSF.
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).
This position is located in South San Francisco, CA and may require up to 10-15% travel.
Other Duties:
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.
Work Environment
This position works in a standard office setting, in a facility that contains laboratory equipment.
AAP/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 toBenefits and Compensation
Aligos Therapeutics provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short and Long Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Critical Illness, Accident, Legal and ID Theft, 401k plan, PTO, and ESPP (Employee Stock Purchase Plan).
The anticipated salary range for fully qualified candidates applying for this role will be $208,000 - $242,000 (not including discretionary bonus, equity, and benefits).
The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity.
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