Associate Director, Clinical Operations

About the role

Avenzo Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing next-generation oncology therapies. This position is based in San Diego and reports to the Executive Director, Clinical Operations.

Responsibilities

• Lead and oversee the planning, implementation, and execution of one or more clinical trials across one or more key programs in accordance with project timelines and budget
• Oversee contract research organization (CRO) and vendor activities and coordinate cross-functional department activities to successfully achieve milestones and quality deliverables in study management, including but not limited to site selection, study start-up, recruitment, study conduct, and database lock and study close-out
• Develop and manage comprehensive program project plans, including but not limited to study protocols, clinical trial budgets, timelines, enrollment, and risk mitigation strategies
• Ensure clinical trials are conducted according to Good Clinical Practice (GCP) guidelines and all applicable regulatory requirements, SOPs, and other quality standards
• Develop relationships with investigators and trial site administrators
• Support development of infrastructure with an emphasis on implementation and use of harmonized, consistent processes and excellence in study management deliverables related to cost-effective, timely, and high-quality clinical trial data
• Collaborate with cross-functional teams to support scenario-based planning to forecast resource and budget needs to contribute to the clinical development plan and execution
• Review resource allocation, utilization, and cost efficiency across all clinical trials
• Serve as the subject matter expert (SME) on study protocol and operations and ensure proper training and education of internal and external resources
• Contribute to the preparation and review of clinical study documents, including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA), and/or Marketing Authorization Application (MAA), updates to the IND, NDA, and other safety reports
• Present at Investigator Meetings as needed
• Effectively communicate clinical trial updates to the team and other appropriate functional groups

Qualifications

• Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, PhD) with 10+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
• Working knowledge of the processes required to operationally execute clinical trials
• Demonstrated capability to proactively manage vendor-supplied resources
• A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH and GCP
• Demonstrated track record in conducting clinical trials in an outsourced model
• Significant experience working in a fast-paced biotech environment
• Experience participating in GCP inspection readiness as part of NDA/MAA activities
• Strong understanding of FDA regulations, GCP, ICH guidelines, and clinical research SOPs
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset

Preferred Qualifications

• Periodic/regular travel, including up to 15% of work time, which may include overnight travel

Physical Demands and Work Environment

• Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasks
• Constant or frequent sitting, standing, or walking
• May lift and/or move objects of various weights
• On-site requirement (Monday through Thursday)
• Noise level in the work environment is usually moderate
• Fast-paced, time sensitive environment with frequently changing priorities
• Handle multiple projects simultaneously

Pay

The salary range for this position is $173,000 to $194,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and years of experience within the job and the industry, education, and skills and certifications.

Benefits

• Group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance
• Short-term and long-term disability insurance
• Flexible spending accounts
• Health savings accounts
• Voluntary insurance programs, including voluntary life, AD&D accident, and critical illness
• 401(k) plan
• Accrual of 10 hours of paid vacation time every month and accrual of 1 hour of paid sick leave for every 30 hours worked
• 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies

Other Compensation

• Eligible to receive an annual discretionary bonus and an equity award, subject to the terms of the applicable employment agreement, plan documents, and Company policies

Equal Employment Opportunity

Avenzo is committed to providing equal employment opportunities to all employees and applicants without regard to an individual’s actual or perceived protected characteristic or characteristics, or any combination of protected characteristics including race (including traits associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniformed service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), the employee or their family member’s status as a victim of a qualifying act of violence, political activity or affiliation, use of cannabis off the job and away from the workplace, association with an individual who has, or is perceived to have, a protected characteristic or characteristics, or any combination of protected characteristics, or any other protected status in accordance with all applicable federal, state, and local laws.