Associate Director, Regulatory Affairs

ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight

cancer by developing therapies that block the CD47 checkpoint pathway. Our lead

candidate, evorpacept, 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.

We are expanding our existing group of exceptionally talented and well-motivated

colleagues to develop and commercialize our lead candidate, evorpacept.

We are looking for a full-time Associate Director, Regulatory Affairs to join our team.

Reporting to an Executive Director, Regulatory Affairs, the Associate Director will be

responsible for executing innovative regulatory strategies in support of the global

development program for evorpacept. In this hands-on role, s/he 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:

Provide dynamic regulatory leadership to project teams and work collaboratively

with cross-functional team members and external contractors/vendors/consultants

to identify optimum and workable 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 the different regional requirements and

the potential interplay between key regulatory agencies.

Support teams through successful regulatory meetings and interactions.

Support/lead (as applicable) the authoring, review and editing of high-quality,

compliant regulatory documents according to specified timelines.

Lead assigned department initiatives and seek opportunities to improve

interdepartmental collaboration.

Build positive professional relationships and trust with teammates and regulatory

authority contacts.

Supervise and provide guidance to other regulatory personnel, as assigned, and

support their career development.

Qualifications:

Minimum Bachelors degree; studies in science, advanced degree desirable

Minimum 8+ years progressive Regulatory Affairs experience; 6+ years with an

advanced science-related degree.

Prior regulatory experience and understanding of therapeutic development in the

field of oncology.

Successful track record of supporting regulatory health authority interactions and

moving products through the development process.

Extensive knowledge of regulatory requirements and experience with US, EU, and

RoW regulatory submissions (IND/CTA/BLA/NDA, etc) in eCTD format.

Extensive experience working on development programs and driving regulatory

strategies specifically relating to the pre-clinical and clinical aspects of the project.

Ability to create and manage detailed timelines and track regulatory activities across

disciplines and territories.

Experience in pediatric, Orphan Drug, Fast Track or Breakthrough Therapy

development and understanding of US and EU regulations related to these expedited

regulatory pathways.

Prior experience in other key functional areas preferred (e.g., research, toxicology,

pharmacology, chemistry/manufacturing, clinical research and/or biometrics).

Strong interpersonal skills, as well as oral and written communication skills.

Highly responsible, self-motivated professional.

Strong leadership skills that include a desire for accountability.

Highly collaborative working style with the ability to influence others.

Superior work ethic that includes working autonomously with an appropriate sense

of urgency and accuracy.

Entrepreneurial orientation with the ability to effectively operate in a dynamic

environment.

Excellent organizational skills that enable the successful execution of multiple

simultaneous projects.

High energy, enthusiasm and passion for the work.

Salary: $180,000-$220,000 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. Hybrid work model acceptable (i.e., part-time in South San Francisco office 2-3

days/week with flexibility to work part-time from home).