Associate Director, Clinical Operations
About The Position
Avenzo Therapeutics, Inc. (“Avenzo” or “Company”) is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, Inc., respectively). Our team is passionate about and committed to advancing a pipeline of potentially differentiated targeted oncology programs that make a difference in the lives of people with cancer. The Company is headquartered in San Diego, California. Reporting to the Executive Director, Clinical Operations, the Associate Director, Clinical Operations will be responsible for the operational aspects of clinical studies. As the operational lead for individual studies, this individual will serve as the primary point of contact for contract service providers (CSPs) involved in all study aspects and will independently work cross-functionally for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables.
Requirements
- 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
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
- Support the creation of internal SOPs & Clinical work practice documents and implementation of these plans for Clinical Operations to operate in accordance with FDA & Global regulations; evaluates and recommends changes to policies or procedures
- Present at Investigator Meetings as needed
- Effectively communicate clinical trial updates to the team and other appropriate functional groups
- 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
Benefits
- medical
- dental
- vision
- 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
- 10 hours of paid vacation time every month
- 1 hour of paid sick leave for every 30 hours worked
- 17 paid holidays each calendar year, including a winter closure
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
