Senior/Executive Director, Clin Development

Senior Director/Executive Director, Clinical Development

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. Our team is passionate about and committed to advancing a pipeline of potential best-in-class 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 Vice President, Clinical Development, the Senior Director/Executive Director, Clinical Development will be responsible for providing critical input into the strategy, development, management, and implementation of clinical studies by closely working across the clinical organization; leading multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions.

Essential Job Functions and Responsibilities:

• Lead the development of clinical study protocols, protocol amendments, study guides, protocol training materials, and other clinical study-related documents based on the global development plan
• Manage clinical proof of concept, pivotal studies, and regulatory submissions
• Provide practical and overarching strategic guidance for preclinical and clinical programs, ensuring that the design, implementation, and conduct of the company's clinical studies
• Deliver unambiguous data and information that allows for clear decision-making and advancement of its developmental efforts
• Take medical responsibility in data analysis and interpretation, reporting, and communication to ensure consistency and relevance of medical content and scientific messages across Clinical Study Reports, health authority briefing books, NDA/BLA submission documents, etc.
• Identify clinical trial sites; work closely with and support Clinical Operations in site relationship activities as required
• Contribute to operational aspects of study conduct and patient enrollment efforts, including participation in site training, initiation and activation, and subsequent site engagement activities
• Maintain focus on robust study conduct and quality data generation
• Demonstrate the ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape
• Clinical development lead for assigned development programs and represents the program to executive leadership and study team members
• Support the recruitment/screening/selection of investigators in collaboration with Clinical Operations; ensure that Good Clinical Practices (GCPs) are followed
• Author clinical reports upon completion or termination of studies
• Accountable for preparing clinical portions of protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales, and benefit/risk ratios
• Provide leadership in Health Authority interactions and the development of regulatory documents
• Attend and present at investigator meetings and site initiation visits as applicable
• Take initiatives with investigator and KOL engagement

Preferred Qualifications:

• MD required, advanced medical or life sciences or a related area degree preferred with 12+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
• Oncology solid tumor clinical development experience is required
• 10+ years of experience in clinical development
• Proven track record of leading clinical development programs from early-phase trials through regulatory submissions
• Strategic leadership skills with the ability to inspire, mentor and manage cross-functional teams
• 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
• This position requires periodic/regular travel, including up to 15 percentage of work time, which may include overnight travel

Physical Demands and Work Environment:

Physical Demands:

• 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

Work Environment:

• Remote: Home office; expected to travel to and work from the Company's headquarters in San Diego from time to time
• San Diego-based: 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

Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.

Salary Range:

The salary range for this position for a Senior Director is $339,000 to $361,000 per year and for an Executive Director $344,000 to $366,000 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:

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. Employees will also be able to enroll in the Company's 401(k) plan. In addition, employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. Employees also enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies. All benefits are subject to the terms and conditions of the applicable plan documents and Company policies, which may be amended from time to time.

Other Compensation:

The hired candidate will be 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.

The information above is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies.