Director, Regulatory Affairs

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Job description

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, 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 .

We are expanding our existing group of exceptionally talented and well-motivated colleagues to develop and commercialize our lead candidate, ALX148. We are looking for a Director, Regulatory Affairs to join our team.

The Director, Regulatory Affairs will be responsible for developing and executing innovative regulatory strategies in support of the global development program for ALX148. In this hands-on role, s/he will provide dynamic leadership and direction to multidisciplined 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. The successful candidate will be required to reside within a commutable distance of our South San Francisco office. ALX Oncology Inc. follows a hybrid work model (i.e., part-time in South San Francisco office with flexibility to work part-time remotely).

Responsibilities:

These include but are not limited to:

• Providing dynamic regulatory leadership to project teams and working 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.

• Prepare and lead teams through successful regulatory meetings and interactions.

• Coordinate 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.

Requirements:

• Minimum Bachelor's degree; studies in science and advanced degree desirable

• Minimum 8-10+ years progressive Regulatory Affairs experience; 6+ years with an advanced degree in Regulatory Affairs.

• Prior regulatory experience and understanding of therapeutic development in the field of oncology.

• Successful track record of interacting with regulatory health authorities and moving products through the development process.

• Extensive knowledge of regulatory requirements and experience with US, EU 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, clinical and CMC 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 and Breakthrough Therapy development and understanding of US and EU regulations related to these regulatory pathways.

• Prior experience in other key functional areas, (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 that you do each day.

Salary: $210,000-$230,000

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.

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