Clinical Operations Assistant

Phanes Therapeutics, Inc.; San Diego (CA); On-site; USD 30,000 - 40,000; Full time

Benefits offered by this job

Bonus opportunities

401(k) with employer match

Medical, dental and vision plans

Generous paid time off

On-site gym

EV charging stations

Job summary

Phanes Therapeutics, Inc. is seeking an on-site Clinical Operations Assistant for our San Diego R&D site.

You will support multicenter oncology trials, help implement clinical trial processes, and assist with start-up to close-out activities under guidance from the head of Clinical Operations. The role requires a Bachelor's degree, strong organizational and communication skills, and the ability to work with global teams in a fast-paced environment.

Qualifications

• Bachelor's degree required.
• Strong communication skills, both oral and written.
• Ability to work with global, multi-disciplinary teams.

Responsibilities

• Support multicenter oncology clinical trials per protocol, ICH GCP, and regulatory requirements.
• Develop and maintain study tools, trackers, and filing systems.
• Add essential documents and maintain TMF/eTMF in compliance with SOPs and standards.
• Review and reconcile TMF/eTMF, address QA/QC findings to ensure quality.
• Track study progress and maintain study status updates across site activities.
• Support training and documentation for study team members; assist with key study activities.

Skills

Oral and written communication

Global collaboration

Organizational skills

Learning mindset

Education

Bachelor's degree

Job description

Function: Clinical Development and Operations

Company: Phanes Therapeutics, Inc.

Phanes Therapeutics, Inc. is a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology. Currently, Phanes is conducting three Phase 2 clinical trials with spevatamig, peluntamig, and mavrostobart. Both spevatamig and peluntamig are first-in-class bispecific antibodies and have been granted orphan drug and Fast Track designations by the FDA.

We are looking for motivated and passionate people to join us to help discover and develop new medicines and improve healthcare. We believe that innovative thinking, seamless execution, teamwork, and integrity are key values for building success. Our mission is to become a major source of innovation in the biotech and pharma industry.

At Phanes, we understand that scientific innovation is a challenging task and that is why we are looking for exceptionally talented people to join us on our mission. We are committed to fostering an innovative and fun working environment where individuals can pursue creative ideas and deliver results, because we know that our success depends on how to realize the true potential of our people.

Job Summary:

This position is in the clinical development and operations function located at our R&D site in San Diego, CA and will report to the head of Clinical Operations. The Clinical Operations Assistant will assist in the implementation and conduct of clinical research projects and provide support for project teams. The position requires acquiring knowledge (through internal training) of clinical trial processes and experience in many aspects of trial execution from study start-up to close-out.

This position is onsite full-time.

Key Responsibilities:

• Support aspects of multicenter oncology clinical trials, ensuring that studies are carried out in accordance with the protocol, ICH GCP, and local regulatory requirements.
• Develop and maintain study tools including trackers, spreadsheets, and filing systems for various studies.
• Add essential documents and maintain TMF/eTMF in compliance with SOPs, ICH-GCP, TMF plans, and work instructions.
• Perform ongoing reviews and reconciliation activities of trial TMF/eTMF, and follow-up on QA/QC findings, to assure quality and compliance with relevant SOPs and ICH-GCP.
• Track study progress and maintain study status updates (e.g., site selection, IRB approvals, regulatory document collection, enrollment, SDV status, study drug inventory, clinical specimen tracking).
• Help manage study team member training and documentation.
• Support key study-related activities and deliverables.
• Participate in Clinical Operations department initiatives and other duties as assigned.

Qualifications:

• Bachelor’s degree required. Fresh college graduates with good GPAs and work experience are encouraged to apply.
• Ability to work well with global, multi-disciplinary teams.
• Must be able to thrive in an entrepreneurial, fast paced, and dynamic work environment.
• Must be organized with excellent oral and written communication skills.
• Strong learning orientation, curiosity, and passion for science and patients.

Our Benefits Include:

• Competitive compensation package including bonus opportunities and stock options opportunities.
• Retirement 401(k) savings plan with employer match.
• Exceptional career growth opportunities.
• Excellent medical, dental and vision plans.
• Generous vacation and sick leave plans.
• 18 paid company holidays per year including a Winter Holiday Break.
• An opportunity to do truly meaningful work to make a lasting impact.
• On-site gym, ample parking including complimentary EV charging stations, company-sponsored events, etc.
• Flexible spending accounts (FSAs) for eligible out-of-pocket health care and dependent day care expenses.
• Health savings accounts (HSAs) a trust or custodial account to pay or reimburse certain medical expenses.
• Life and AD&D insurance, short- and long-term disability plans.
• Employee assistance program (EAP) provides employee counseling programs and various online resources.
• Additional voluntary benefits include pet insurance, auto and home insurance, commuter benefits, legal plans, and more.

The hourly wage we reasonably expect to pay is $22.00 - $28.80 per hour. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.