Executive Director, Clinical Development

Avenzo Therapeutics, Inc.; United States; Remote; USD 346,000 - 383,000; Full time

Benefits offered by this job

Equity award

Discretionary bonus

Job summary

Avenzo Therapeutics, Inc. seeks an Executive Director, Clinical Development to lead strategy, development, and regulatory submissions for oncology programs. This senior role reports to the VP of Clinical Development and guides multi-disciplinary teams across global studies.

The position requires an MD with 12+ years in life sciences, oncology experience, and a proven record of leading development programs from early phases through regulatory submission. Travel up to 15% may be expected.

Qualifications

• MD required; advanced medical or life sciences degree preferred with 12+ years in life sciences.

Responsibilities

• Lead development of clinical study protocols and related documents.
• Manage clinical proof of concept, pivotal studies, and regulatory submissions.
• Provide strategic guidance for preclinical and clinical programs.
• Deliver data for decision-making across Clinical Study Reports and NDA/BLA documents.
• Identify clinical trial sites and support site relationship activities.
• Contribute to operational aspects of study conduct and enrollment.
• Maintain robust study conduct and quality data generation.
• Develop innovative clinical strategies to shorten development cycles.
• Lead clinical development programs and represent to executives.
• Support investigator recruitment and ensure GCP compliance.
• Author clinical reports and deliver protocols and reports.
• Provide leadership in Health Authority interactions.

Education

MD

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Executive Director, Clinical Development

Full Time CA - Corporate Office

6 days ago Requisition ID: 1034

Salary Range: $346,000.00 To $383,000.00 Annually

Job Title: Executive Director, Clinical Development

Location: San Diego or Remote U.S.

Job Type: Full-Time

Who We Are

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.

Position Summary

Reporting to the Vice President, Clinical Development, the 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
• 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 is $346,000 to $383,000 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.

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.

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 other protected status in accordance with all applicable federal, state, and local laws.

Notice to Search Firms/Third Party Agencies

Avenzo does not accept unsolicited resumes from recruiters, employment agencies or search firms without a valid, executed search agreement in place.