Associate Director, Regulatory Affairs

Kymera Therapeutics

Watertown, MA, US
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Post Date: 02/11/2021
  • Website: kymeratx.com
  • Company Address: 400 Technology Square, 10Th Floor, Cambridge, MA, 02139

About Kymera Therapeutics

Kymera Therapeutics is a biotechnology company pioneering a transformative new approach to treating previously untreatable diseases. The company is advancing the field of targeted protein degradation, accessing the body’s innate protein recycling machinery to degrade rather than inhibit dysregulated, disease-causing proteins. Powered by a proprietary predictive modeling capability and a game-changing integrated degradation platform, Kymera is accelerating drug discovery with an unmatched ability to target and degrade the most intractable of proteins, and advance new treatment options for patients.

Job Description

We are seeking a talented Regulatory Affairs professional to join our fast-growing regulatory team and act as the program regulatory lead on one or more Kymera development programs. The ideal candidate is a hands-on, dynamic team player able to navigate complex regulatory requirements across disciplines including CMC, nonclinical and clinical. We are seeking someone with excellent project management, communication, and negotiation skills with experience successfully operating in a small or mid-sized biotech environment. Experience should include directly authoring, managing and overseeing significant regulatory submissions, communicating with health authorities, and providing strategic regulatory guidance to cross functional program teams through early and mid-stage development. This position is an excellent opportunity to play a critical role in the build out of Kymera’s regulatory team and is best suited for a highly motived individual passionate about contributing to the forward progress of a potentially transformative new class of drugs.

Kymera Therapeutics is a biotechnology company focused on advancing the field of targeted protein degradation (TPD), a transformative new approach to address previously intractable disease targets. Kymera’s Pegasus™ TPD platform harnesses the body’s natural protein recycling machinery to degrade disease-causing proteins, with a focus on undrugged nodes in validated pathways currently inaccessible with conventional therapeutics. Our mission is to discover, develop, and commercialize transformative therapies while leading the evolution of targeted protein degradation. Kymera’s goal is to become a fully integrated biopharmaceutical company with a pipeline of novel medicines, with an initial focus on immune-inflammatory diseases and oncology.

In 2021, we plan to continue to grow and strengthen our organizational capabilities to deliver on the potential of inventing a new class of protein degrader medicines for patients. Kymera is rapidly advancing toward the clinic with three programs planned to begin clinical studies this year. We are also actively advancing a broad pipeline of preclinical programs across a wide variety of diseases, both internally and in collaboration with our partners Sanofi and Vertex Pharmaceuticals.

 

Responsibilities:

  • Acts as the overall regulatory lead for one or more assigned programs, including developing and driving overall regulatory strategy, directly authoring, managing, and overseeing all regulatory submissions, and acting as the Kymera point of contact with US FDA and other global health authorities.
  • Provides sound, science-based, solution-oriented regulatory guidance and advice to cross functional program teams through strategic and flexible application of experience and regulatory knowledge.
  • Leads and manages program teams through major regulatory filings and interactions (INDs, Agency Meetings).
  • Manages CROs responsible for Ex-US clinical trial regulatory submissions.
  • Tracks relevant regulatory intelligence data and interprets and disseminates to internal teams.
  • Contributes to defining and implementing standard processes and best practices for the Kymera regulatory group.
  • Monitors the development of emerging regulations and guidance and advises on impacts to programs or business operations.
  • Manages and oversees contractors and consultants.
  • Mentors and trains junior regulatory team members.

 

Qualifications:

  • Bachelor’s degree in a scientific discipline, advanced degree preferred but not required.
  • 8+ years of Regulatory Affairs experience in a generalist capacity with demonstrated progression in roles and responsibilities, ideally in small to mid-size company environments.
  • Experience acting as a regulatory program lead or exemplary work in a progressive series of supporting roles with the skill set, drive and desire to act as the regulatory program lead.
  • Experience in directly authoring a broad range of regulatory submissions.
  • Experience in small molecule early and mid-stage drug development. Late-stage experience (pre-NDA through post marketing) beneficial but not required.
  • Experience in oncology, immunology and/or orphan/rare diseases is highly desirable.
  • Excellent understanding and knowledge of global drug development and regulatory principles and practices with the motivation to continually learn and build on existing skills and knowledge base.
  • Demonstrated ability to lead teams, internal and external, through excellent interpersonal and communication skills.
  • Someone recognized continuously for their attention to detail.
  • A self-starter willing to take on new challenges, work outside their areas of comfort and collaborate cross functionally to contribute to the success of their programs.

 

Kymera Therapeutics is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

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This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.