Senior Director, Regulatory Affairs

ALX Oncology (ALX) is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. For more information about us, please visit www.alxoncology.com.  

We are looking for an exceptionally talented and motivated individual to join our team as Senior Director, Regulatory Affairs. This position will be responsible for developing and executing innovative regulatory strategies in support of the global development program for ALX148. In this hands-on role, the individual will provide dynamic leadership and direction to multi-disciplined project teams and will work collaboratively with cross-functional team members to achieve development milestones in an efficient and compliant manner. This position will also support and provide key contributions to department and company initiatives related to regulatory affairs operations and strategy.

Responsibilities:

These include but are not limited to: 

• Providing dynamic regulatory leadership and guidance to project teams and working collaboratively with cross-functional team members, external contractors, vendors and consultants to identify optimum and effective regulatory strategies for assigned projects.
• Lead teams in examining regulatory strategy options, provide relevant regulatory guidance / precedents and stay abreast of the regulatory and competitive landscape.
• Identify and assess regulatory risks associated with development programs and define strategies to mitigate risks.
• Monitor and analyze regulatory agency activities in areas of interest to the company and assess potential impact on development programs. Take a global view of regulatory strategy and help teams navigate regional requirements and the potential interplay between key regulatory agencies.
• Prepare and lead teams through successful regulatory meetings and interactions.
• Lead the authoring, review and editing of high-quality, compliant regulatory documents according to specified timelines and goals.
• Lead assigned department initiatives and seek opportunities to improve interdepartmental collaboration.
• Build positive professional relationships and trust with team mates, collegues and regulatory authority contacts.
• Assist in organization and management of staff in the RA group, including coaching, career development and oversight of work.

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.

To apply for this position, please send your cover letter and resume to hr@alxoncology.com