What are the responsibilities and job description for the Senior Director, Regulatory Affairs position at Avenzo Therapeutics?
Job Title: Senior Director, Regulatory Affairs
Location: San Diego or Remote U.S.
Job Type: Full-Time
Who We Are
Avenzo Therapeutics, Inc. (“Avenzo”) 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). With a proven track record in building and scaling biotech companies, our experienced management team is passionate about and committed to building a pipeline of potential best-in-class targeted oncology programs. The company is headquartered in San Diego, California.
Position Summary
Reporting to the Senior Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs will have the opportunity to shape both program-level strategy and the evolving regulatory function within a dynamic, mission-driven organization. This individual will be responsible for primary authorship and supporting regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements.
Essential Job Functions And Responsibilities
Physical Demands
Anticipated Base Salary Range
The salary range for this position is $276,400 to $287,500 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.
Applications for this position are anticipated to close on June 30, 2026. For more information about this posting, please contact careers@avenzotx.com .
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.
Notice to Search Firms/Third Party Agencies
Avenzo does not accept unsolicited resumes from recruiters or employment agencies without an executed search agreement in place.
Location: San Diego or Remote U.S.
Job Type: Full-Time
Who We Are
Avenzo Therapeutics, Inc. (“Avenzo”) 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). With a proven track record in building and scaling biotech companies, our experienced management team is passionate about and committed to building a pipeline of potential best-in-class targeted oncology programs. The company is headquartered in San Diego, California.
Position Summary
Reporting to the Senior Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs will have the opportunity to shape both program-level strategy and the evolving regulatory function within a dynamic, mission-driven organization. This individual will be responsible for primary authorship and supporting regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements.
Essential Job Functions And Responsibilities
- Develop and execute U.S. and global regulatory strategies for one or more solid tumor oncology programs across the clinical development lifecycle, aligned with corporate and program objectives
- Serve as the Regulatory Affairs lead on cross‑functional program teams, providing regulatory guidance to Clinical, CMC, Biometrics, Pharmacovigilance, Quality, and other stakeholders
- Lead the strategic planning, review, and execution of regulatory submissions and maintenance activities (e.g., INDs, CTAs, amendments, briefing packages, and, as applicable, BLAs/MAAs), ensuring compliance with global regulatory requirements
- Assess and pursue oncology-specific expedited programs and designations, including Fast Track, Breakthrough Therapy Designation, Orphan Drug Designation, Accelerated Approval, and EMA PRIME, as appropriate for solid tumor indications
- Lead and coordinate health authority interactions, including meeting strategy, preparation and oversight of briefing documents, responses to requests for information, and management of post‑meeting commitments
- Conduct regulatory risk assessments and gap analyses; identify potential issues and develop mitigation strategies to support successful regulatory outcomes
- Provide regulatory leadership in the assessment of emerging clinical data and operational activities, evaluating regulatory impact and advising on strategy adjustments as needed
- Contribute to and/or lead the development and review of key regulatory documents, including, clinical protocols, and clinical and nonclinical study reports
- Drive high‑quality execution of regulatory deliverables, including alignment of timelines, content consistency across documents, and adherence to internal standards and best practices
- Translate evolving global regulatory guidance and regulatory intelligence into actionable recommendations for program teams and senior leadership
- Support the growth and scalability of the Regulatory Affairs function through process improvement, cross‑functional alignment, and mentoring of internal team members and external partners, as appropriate
- 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 10% of work time, which may include overnight travel
- Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, Ph.D.) with 12 years of regulatory affairs experience in the life sciences industry or an equivalent combination of academic and industry experience
- Direct experience supporting early-stage (pre-IND to Phase 1/2) solid tumor oncology programs
- Familiarity with multiple oncology modalities (e.g., small molecules, biologics, ADCs)
- Demonstrated ability to develop, lead, and implement global regulatory strategies for complex development programs across multiple phases of the product lifecycle
- Extensive knowledge of U.S. and international regulatory requirements, including FDA and EMA regulations, guidance, and industry standards applicable to oncology development programs
- Proven experience leading major regulatory submissions and global filing activities (e.g., INDs, CTAs, and, as applicable, BLAs, MAAs, NDAs/NDSs)
- Demonstrated success leading regulatory interactions with health authorities, including briefing package development, response strategy, and negotiation of regulatory positions and commitments
- Strong track record of independent decision‑making, regulatory risk identification, and development of mitigation strategies affecting program and portfolio outcomes
- Demonstrated ability to influence and lead cross‑functional teams in a matrix environment, providing strategic regulatory guidance to Clinical, CMC, Biometrics, Pharmacovigilance, and related functions
- Strategic thinker with strong analytical judgment, problem‑solving skills, and the ability to thrive in a fast‑paced, evolving biotech environment
- 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 10% of work time, which may include overnight travel
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
Anticipated Base Salary Range
The salary range for this position is $276,400 to $287,500 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.
Applications for this position are anticipated to close on June 30, 2026. For more information about this posting, please contact careers@avenzotx.com .
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.
Notice to Search Firms/Third Party Agencies
Avenzo does not accept unsolicited resumes from recruiters or employment agencies without an executed search agreement in place.
Salary : $276,400 - $287,500