Senior Vice President, Head of Regulatory Affairs and Quality Assurance

ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.

The Senior Vice President, Head of Regulatory Affairs and Quality Assurance will be responsible for developing and driving the execution of the global regulatory strategy. The ideal candidate is creative with high ethical standards and strong leadership skills. The candidate must be comfortable in a fast-paced environment with drug development professionals, and is thoughtful when prioritizing regulatory workstreams.

Reporting to the Chief Medical Officer, the Head of Regulatory Affairs and Quality Assurance will provide long term global regulatory strategies, vision and direction to optimize our Company’s oncology portfolio.

Major Duties/Responsibilities:

Develop, and create alignment around global regulatory strategies in collaboration with the executive leadership team.
Provide regulatory guidance to executive leadership and project teams in all areas of regulatory affairs throughout the research and development process, approval, and post approval phases.
Oversee regulatory and team interactions with health authorities, submission management activities, regulatory function processes.
Responsible for ongoing growth of the quality and regulatory teams.
Provide guidance on critical impact regulatory submissions, due diligences for potential out-licensing activities and external collaborations.
Partner with the executive team to lead the overall quality vision within the company and drive / promote a culture of continuous improvement.
Oversee the strategic development and execution of the GxP Quality. Management System to support the evolving nonclinical, clinical and commercial development programs to ensure patient safety, IMP quality, and data integrity.
Oversee GMP QA and QC activities to assure compliance, appropriate vendor oversight and continuous clinical supply.
Oversee the regulatory team to develop and communicate project timelines for regulatory filings; oversee all activities in support of INDs, NDAs, CTAs, BLAs, and other regulatory submissions.
Oversee the preparation, submission and follow-up contact with regulatory agencies for all applications and submissions. Provide regulatory review and final approval for all submissions and associated documentation.
Participate in regulatory and CMC due diligence activities for licensing candidates in collaboration with business development group.
Play a lead role in updating and preparing the company for major changes in legislation which impact across functions.
Ability to travel as needed.

Qualifications:

Science degree (PhD, PharmD, MD, MSc) with extensive experience in regulatory leadership.
Minimum 15+ years of relevant regulatory leadership experience in biotech and pharmaceutical industry, oncology drug development program experience.
Proven track record of success in supporting Phase I-III clinical trials and progressing programs including INDs, early and late-stage development plans to completion with FDA, PMDA, and other global health authorities.
Expertise working within a GxP compliant arena.
Experience with biologics through approval is preferred.
Excellent strategic planning, team building and leadership skills.
Demonstrated ability to develop and maintain excellent working relationships with US FDA, PMDA, and similar key international regulatory agencies.
Excellent interpersonal communication and presentation skills to facilitate collaboration across functions and building successful relationships with internal and external stakeholders.

Success Factors:

Demonstrates behaviors consistent with ALX Oncology values and culture.
Understands how regulatory and quality activities contribute to company development and commercialization goals and takes measures to maximize these values to the organization.
Demonstrates independence and high competence in the leadership of all regulatory and quality responsibilities.
Establish and maintain collaborative working relationships with all key stakeholders, and internal and external customers and ensure the same across relevant teams.
Ensures compliance with all governing laws, regulations, Quality Management System (QMS), ALX Oncology standard operating procedures (SOPs) and other guidelines.
Acts independently to oversee regulatory and quality responsibilities across teams.
Proactively takes on responsibility for complex deliverables.
Brings critical, systematic thinking to shape current issues and opportunities into meaningful, deliverable actions.
Demonstrate ability to lead and influence, with and without authority, in a global matrix environment.
Proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships.
Ability to mentor, and coach within department and cross functionally as well as lead global work groups.

Salary: $360,000-$410,000 DOE

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.