Actym Therapeutics, Inc. is a Berkeley, CA based venture-backed biotechnology company focused on developing novel immunotherapies intended to transform the treatment of cancer. Patients burdened with metastatic disease desperately need new and effective treatment options. Actym’s revolutionary microbial-based technology platform is designed to overcome the hostile tumor microenvironment and promote durable anti-tumor immunity. This technology allows for the safe, programmed delivery of multiplexed immunological payloads to tumor-resident immune cells after IV dosing, in a single therapeutic composition. This paves the way for safely targeting immunological pathways that are intractable using conventional small molecule or antibody-based therapeutics due to systemic toxicities, which are of significant interest to the biopharma community. Actym recently completed a significant venture financing backed by top tier investors and has announced a lead therapeutic candidate for clinical development.
Actym seeks a highly motivated Sr. Clinical Trial Manager or Sr. Manager Clinical Operations to join our growing Clinical Development Department. This role will serve as the clinical operations project lead for clinical trials including project planning, budget and resource management, and oversight of the Contract Research Organization(s) and project vendors.
- Manage/oversee the conduct and execution of an assigned clinical trial and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements.
- Assists with the identification, review and selection of appropriate investigational sites and vendors.
- Responsible for management and oversight of CROs, and selected study vendors; ensuring all vendors meet the predetermined program milestones according to budget and timeline.
- Help develop and manage clinical site budgets and vendor contracts, including review of invoices for accuracy, working closely with our finance department.
- Works closely with study team to prepare and maintain manuals, forms, plans and documents, and participates in internal cross-functional study team meetings.
- Ensures compliance with GCP and global regulatory guidelines.
- Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial
- Recommend and implement innovative processes to improve and impact clinical trial management and deliverables including contingency plans.
- Works with Data Management to create and implement study-specific tools to ensure clean data and timely data entry.
- Acts as a cross functional liaison to ensure study plan aligns with program level goals.
- Bachelor’s degree (or equivalent) in a relevant scientific field preferred.
- Minimum of 6 years of clinical trial experience including clinical trial management, in pharmaceutical, biotech or CRO setting; oncology and/or GMO study experience preferred.
- Experience in Phase I-III clinical trials. Global experience preferred.
- Thorough knowledge of drug development, clinical operations processes, and procedures according to FDA GCP/ICH regulatory guidelines.
- Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.
- Able to recognize need(s), find solutions and take initiative to address in proactive manner.
- Strong organizational and time management skills.
- Excellent communication skills, both oral and written.
- Strong team player with demonstrated track record of success in a cross-functional team and fast-moving environment.
- Proven ability to effectively collaborate with internal team and external collaborators.
- This position may require up to 10% domestic travel and limited international travel.
Work is performed in an office and laboratory environment. May be exposed to biological and chemical hazards. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. Light to moderate lifting and carrying objects with a maximum lift of 30lbs. Must be able to work while wearing personal protective equipment such as safety glasses, gloves, and lab coats deemed necessary to protect testing and to protect employees. Work is to be performed on site.
Actym offers comprehensive benefits including 401K, PTO, and generous health care coverage with Medical, Dental, Vision plans.
This job description is not necessarily a comprehensive list of all duties and responsibilities. The employer reserves the right to revise key functions of this position at any time. Actym is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.