Senior Mrg/Associate Dir, Clinical Science
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 Science, the Senior Manager/Associate Director, Clinical Science will provide scientific and clinical support for the design conduct, analysis, and reporting of clinical trials. This role contributes hands-on clinical expertise across study teams while collaborating closely across the organization to ensure high-quality scientific execution.
Requirements
- Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, Ph.D., MPH, PharmD) with 6+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
- Experience conducting clinical data listing reviews and demonstrating familiarity with standard clinical and regulatory references (e.g., CTCAE, MedDRA)
- Working knowledge of principles and techniques of clinical data analysis and interpretation
- Experience reviewing and contributing to clinical study protocols and related documents
- Knowledge of GCP (Good Clinical Practice), ICH, FDA, EMA, and other relevant guidelines and regulations
- Proven ability to collaborate within cross-functional teams
- Ability to understand and assimilate complex scientific and clinical information.
- Demonstrates initiative, strong organizational skills, and attention to detail.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Electronic Data Capture systems (e.g., RAVE), J-Review, or similar data review tools
- 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
- Serve as the Clinical Science representative on cross-functional study teams, providing scientific and clinical input to support study planning, execution, data review, and study-related decision-making
- Contribute to the design and development of clinical studies, including protocol development, feasibility assessments, study-related documents, and clinical sections of regulatory submissions (e.g., INDs, Investigator's Brochures, DSURs, regulatory responses, and case report forms)
- Partner with Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, Regulatory Affairs, and external vendors to support study execution, protocol compliance, subject safety, and overall trial oversight
- Conduct ongoing clinical review of safety and efficacy data, including data trend analysis, signal identification, assessment of data quality and completeness, and communication of observations and recommendations to study teams
- Support safety monitoring activities through participation in safety review meetings, Data Monitoring Committees, review of safety narratives and safety-related documents, and collaboration with Medical Monitoring and Pharmacovigilance colleagues
- Develop and review study training materials and support investigator meetings, site initiation visits, and other study-related training and communication activities
- Author and review clinical narratives, support data review and study closeout activities, and contribute to clinical study reports and other study deliverables
- Interact with investigators, key opinion leaders, and other internal and external subject matter experts to support study conduct and ensure alignment with scientific and regulatory requirements
- Contribute to study planning activities, including review of CRO deliverables, study budgets, scopes of work, and operational plans in collaboration with Clinical Operations and Clinical Outsourcing
- Support scientific communications through development of presentations, abstracts, posters, publications, and other internal and external materials
- Review scientific literature, emerging clinical data, and competitive intelligence to support study execution and clinical development activities
Benefits
- medical insurance
- dental insurance
- vision insurance
- basic life and AD&D insurance
- short-term disability insurance
- 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
- paid vacation time
- paid sick leave
- paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Senior
