Senior Director, Regulatory Affairs

At Adaptive, we’re Powering the Age of Immune Medicine.  Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated.

As an Adapter, you’ll have the opportunity to make a difference in people’s lives. With Adaptive, you’ll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application.

It’s time for your next chapter. Discover your story with Adaptive.

Position Overview

Adaptive is searching for a Senior Director, Regulatory Affairs to function as a key leader within our Measurable Residual Disease (MRD) business responsible for proactively developing, leading, and driving the execution of the global regulatory strategy for Adaptive’s diagnostics business.  This includes, but is not limited to, leading the development of timely regulatory plans for Adaptive’s diagnostic products, advising on product development and commercialization initiatives, and maintaining accountability for global regulatory compliance across the organization.

Reporting directly to the Chief Commercial Officer of our MRD Business Unit, you will manage a team of direct reports and also work collaboratively with Commercial, R&D, Operations, Quality Assurance, and Legal leadership to accomplish Adaptive’s regulatory and corporate objectives. 

Leaders at Adaptive demonstrate behaviors consistent with Adaptive’s Core Values and Leadership Principles. Critical functions of your role include helping establish individual team member goals, aligning those individual goals with broader team objectives, and ensuring those objectives drive the achievement of company goals. Providing thoughtful coaching and consistent feedback to your team members will drive performance excellence and accountability, as well as support your team members’ growth and development. Leaders at Adaptive create an environment of belonging, respect, and open and honest communication every day.  

Key Responsibilities and Essential Functions

• Provide management and leadership to the Regulatory Affairs team in the development and implementation of regulatory strategies and processes
• Lead the planning and preparation for meetings with regulatory agencies, and represent Adaptive during meetings and negotiations with regulatory agencies
• Monitor, interpret and communicate any emerging regulations, global regulatory trends, and guidelines.  Assess their impact on Adaptive’s products and operations and bring forward findings and recommendations.
• Monitor competitors’ regulatory activities and changes to anticipate potential impacts on the Adaptive’s products and regulatory strategies.
• Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies, within applicable regulations and guidelines; ultimate responsibility for reviewing and approving relevant regulatory filing documentation
• Assume responsibility for regulatory component of IVDR compliance
• Provide counsel, training and interpretation of FDA and global regulatory requirements to all company personnel
• Provide regulatory oversight and guidance for compliant product promotion
• Serve as primary contact responsible for communications with the U.S. and global regulatory agencies.  Develop and maintain external relationships with relevant opinion leaders and regulatory officials
• Identify and assess regulatory risks related to planned clinical development activities; develop mitigation strategies and work closely with cross-functional teams to ensure risk assessments are integrated into product development and lifecycle management processes.
• Leverage knowledge of pharma drug development trends and evolving regulatory agency viewpoints on MRD in hematology to inform a forward-looking regulatory strategy that supports expansion of Adaptive’s MRD pharma business.
• Work cross-functionally with collaborators to support delivery of pharma partner regulatory requirements, including clinical trials IDEs and other relevant applications.
• Understand and translate regulatory intelligence, scientific, operational and business knowledge into effective strategy and implementation plans for key product development initiatives.
• Direct the development of systems, practices and processes to ensure effective ongoing review of product design or other operational and manufacturing changes.
• Partner with Quality to oversee post-market regulatory surveillance, and reporting, and regulatory audits to ensure compliance and optimal market access.
• Set and maintain regulatory policies and standard operating procedures (SOPs) to ensure compliance with applicable regulations worldwide.  Train cross functional teams according