Senior Director/Executive Director Regulatory Affairs (CMC)

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/Executive Director, Regulatory Affairs (CMC). This position will be responsible for developing and executing innovative global regulatory strategies in support of the chemistry, manufacturing, and controls (CMC) development for ALX148, as well as ALX’s pipeline products. In this lead, hands-on role, the successful candidate will provide dynamic leadership and direction to senior management and product development teams and will work in close partnership with the CMC/Quality leadership to achieve development milestones in an efficient and compliant manner.

This position will also help to develop and provide key contributions to the broader Regulatory Affairs department. This is a hybrid position with possibility for both in office and remote work at home. This position requires a strong scientific background with understanding and experience in large molecule biologic cGMP manufacturing, analytical practices, and relevant regulatory guidelines to contribute to and shape the overall manufacturing strategy.

The successful candidate will interface cross-functionally in a matrixed environment to integrate CMC plans with overall development plans and ensure planning, coordination, and communication to develop timely and robust regulatory strategies and submissions to meet overall program objectives/milestones. We seek a self-starter with exceptional experience, leadership, communication and organizational skills. Attention to detail, as well as excellence in fostering high performing cross-functional teams and the ability to work and influence in a matrixed environment.

Responsibilities:

• Lead / manage all aspects of CMC regulatory strategy development for ALX’s products (early- to late-stage/registration/post-market).


• Lead teams in examining regulatory strategy options, provide relevant regulatory guidance / precedents.
  


• Identify and assess regulatory risks / critical-path activities associated with ALX’s CMC development programs and work to identify regulatory strategies to mitigate risks.


• Problem-solve in a collaborative manner to mitigate risks.


• Monitor and analyze regulatory agency activities with regard to CMC development and assess potential impact on the ALX development programs and stay abreast of the regulatory                  landscape.
  


• Assume a global view of CMC regulatory strategy and help teams navigate regional requirements and the potential interplay between key regulatory agencies.              

• Evaluate proposed manufacturing changes for global impact and provide strategic regulatory strategies that support compliant change implementation.


• Serve as CMC Regulatory Lead on cross functional project teams to achieve project milestones/goals.


• Serve as the Regulatory point of contact for Contract Manufacturing Organizations and Qualified Persons.


• Lead global CMC regulatory submission development - Responsible for planning, coordinating and developing high quality, compliant and timely CMC (Quality) regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, BLA/MAA, pre-meeting briefing documents, etc.).


• Serve as Regulatory Lead for CMC-focused FDA and EU and RoW Scientific Advice meetings. · Review and provide comments on change controls, SOPs, product container labeling, product specifications, comparability protocols and reports, quality agreements, pharmacy manuals, investigator brochures, and other related CMC documents.


• Provide timely and transparent communication to team/stakeholders to ensure appropriate cross-functional communication. Regularly communicate project status including expectations, opportunities and risks via written communication, presentations, discussions and informal interactions, as appropriate.


• Assist in organization and management of staff within the RA group, including coaching, career development and oversight of work, as required.


• This position may require periodic travel (domestic/international).

Education/Experience/Capabilities:

• Bachelor’s degree (or equivalent) in life sciences, masters or advanced degree preferred.


• 10 years working within the biotech/pharmaceutical industry.


• 8 years of pharma and/or biotech regulatory CMC-experience with a demonstrated track record of regulatory success and increasing levels of responsibility.


• Extensive understanding and knowledge of large molecule biologics manufacturing and analytical development validation.


• Extensive knowledge of cGMP, CMC regulatory requirements in the US, EU and RoW.


• Ability to lead matrixed teams, drive and influence effective collaborations. · Sharp critical thinking/problem solving skills.


• Capable of managing multiple projects, excellent time management skills.


• Strong scientific writing and oral communication skills with ability to summarize clearly and succinctly and tailor messaging to target audience.


• Self-motivated, self-disciplined, and able to function independently as well as part of a team.


• Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc.


• Must show proof of full COVID-19 vaccination to attend onsite at our South San Francisco office

ALX Oncology is an equal opportunity employer. All applicants must 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.