Actym Therapeutics, a Bay Area biotechnology company, is seeking a highly motivated Associate Director, 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.

Responsibilities:

• 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.
• Responsible for 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.
• Works closely with study team to prepare and maintain manuals, forms, plans and documents, and participates in internal cross-functional study team meetings.
• Contribute to the writing and review of clinical documents such as, protocols, informed consents, investigator brochures, and clinical study reports.
• 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.
• Ensure clinical studies are executed within projected budget, on time, and with highest quality.
• Develop and manage clinical site budgets and vendor contracts, including review of invoices for accuracy.
• 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.
• Write and/or review clinical operations SOPs and related quality documents including, but not limited to, training, tools, templates, CRO manuals, and vendor oversight plans

Qualifications:

• 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 approximately 15% domestic travel and limited international travel.

About Actym: