A2 Biotherapeutics (51-200 Employees, 113% 2 Yr Employee Growth Rate)
At A2, our mission is to extend the reach of cell therapy to tackle the next frontier in cancer treatment: solid tumors. Our team is dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illness. Central to achieving this mission is our focus on recruiting the best talent and building an environment that enables our team to do the best work of their careers and make an impact on patients and society at large.
Reporting to the Director of Clinical Operations, the Clinical Trial Manager will be a key member of the Clinical Development Operations Team. In this role you will help build the foundations for clinical operations as we take our first program into the clinic. You will manage all logistics for patient samples, ensure data is complete and accurate, and manage site and vendor relationships. Your role will play a key role in patient identification through innovative genetic data analysis and you will have publication opportunities. This is a great opportunity to join a highly experienced team and make an impact on the large unmet need for therapy in solid tumors.
This position can be remotely based (in the US) for the right candidate or located at our Agoura Hills, CA location.
- Manage and liaise with stakeholders cross-functionally and externally for sample receipt and processing.
- Track and provide study metrics for timepoint analysis of all patients.
- Logistical management of patient samples and data to support study milestones.
- Make and execute decisions on sample routing/processing.
- Direct point of contact for investigational site support.
- Manage and maintain relationships with study vendors.
- Provide oversight of clinical monitoring and site management and maintain robust site relationships including patient data and eTMF.
- Provide support to the study team as required, including but not limited to meeting minutes, tracker maintenance, study document filing.
- Assure regulatory compliance of investigational sites with Sponsor’s SOPs and FDA and ICH guidelines.
- Support contract negotiations with vendors and clinical sites for clinical trial services.
- Maintain an in-depth knowledge of legal requirements related to day-to-day management of employees, reducing legal risks and ensuring regulatory compliance.
- Partner with the legal department as needed/required.
- Masters degree and 3+ years of relevant academic or pharmaceutical clinical research experience OR
- Bachelor's degree and 5+ years of relevant academic or pharmaceutical clinical research experience.
- Strong working knowledge of and interest in complex cell immunology.
- Ability to manage and motivate multidisciplinary CRO teams critical to subject treatment, safety and trial oversight.
- Excellent oral and written communication skills to communicate effectively with KOLs and CROs and sponsor stakeholders.
- Strong organizational abilities in order to program and project manage complex chain of custody, chain of identity and biological sample management critical in cell therapy.
- Expertise of GCP, ICH guidelines and FDA regulations.
- Demonstrated ability to work independently and in a team environment.
- Extensive experience in a variety of laboratory databases, electronic data collection (EDC), electronic capture report forms (eCRF) electronic medical records (EMR) and eTMF platforms.
- Budgets, contracts and accounts payable experience.
At A2 we believe in investing in our team. Our benefits are just one of the many ways we strive to help our employees take care of themselves and their families. We offer a variety of programs, from comprehensive medical insurance to generous time off policies designed to help meet the needs of our diverse team.
- Competitive base salary and annual incentive opportunities
- Equity participation
- Comprehensive health and welfare benefits (including medical, dental, vision, life, disability, and accident insurance)
- Wellness and recognition programs
- Paid time off and holiday
- Flexible work arrangements (including hybrid work arrangements)
- Paid parental leave
- Environment where professional development is actively encouraged and supported
A2 is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status.
A2 requires all staff to be vaccinated against COVID-19 as a condition of employment. In accordance with applicable law, A2 will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief.