Job Opportunities

Director, Regulatory Operations & Program Management

Location: San Francisco, CA

About the position

Enliven Therapeutics is dedicated to advancing small molecule drug development programs in oncology. This position is responsible for creating the project management function and managing cross-functional drug development project teams/sub-teams to ensure all project milestones and deliverables are met, and that tasks are well executed. Responsibilities will include partnering with the functional team leads to create the program plan, as well as day-to-day planning, co-ordination, and tracking of key activities to ensure that that project timelines are met. In addition, this person will develop and manage regulatory operations activities for products at all stages of development through interacting with internal and external subject area experts, managing global submissions for clinical trials, market authorization, discussions with health authorities regarding program design, implementation, product manufacturing and quality, and any emerging issues with ongoing programs or approved products.

Key Responsibilities

Regulatory Operations

  • Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions
  • Provide regulatory operations support to clinical research, clinical operations, CMC, QA, and non-clinical activities
  • Communicate with management on regulatory status of products and significant regulatory issues
  • Author regulatory development plans and timelines for global clinical trial applications and market registrations (INDs/IMPDs/CTAs, NDAs/MAAs)
  • Manage for regulatory dossier submissions around the world in both eCTD and non-eCTD formats; including submission of CTA and IND applications, and writing, formatting, and submitting eCTDs
     

Program Management

  • Partner with the functional leads to optimize decision making and team effectiveness. Work with the team to create the project plan. Drive information flow through the organization and communicate key program updates to stakeholders.
  • Creates and maintains timelines and ensures programs remains on schedule. Timeline will include all key activities, interdependencies, milestones, and clear identification of activities on critical path. 
  • Aid project teams in framing project work, prospectively identify risks and opportunities, highlight resource constraints, understand issues, prepare mitigation and contingency plans as well as facilitate resolutions. 
  • Facilitate team meetings to drive to good decisions in a fun, efficient way. Work with the functional leads and extended team to develop and distribute agendas. Facilitate meetings and keeps them on track. Create meeting minutes and drive follow up on actions. 
  • Maintain electronic platforms for use by team and creates/maintains easily accessible, high level program documents in electronic format.
  • Identify and communicate key information, timelines, project risks, and resource constraints to senior management and Board of Directors via written communications, presentations, and verbal updates. 
  • Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions

Qualifications

  • Bachelor’s degree in Life Science discipline or equivalent, advanced degree preferred
  • 8+ years in the pharmaceutical/biotechnology regulatory affairs
  • Thorough understanding of FDA/EMA regulatory and drug development processes
  • Experience with US and international regulatory submissions preferred
  • Experienced in preparing / reviewing regulatory submissions including INDs/IMPDs and NDAs preferred
  • General business computer, database system, and software application proficiency


Interested applicants, please send resume to: hr@enliventherapeutics.com

Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.

Enliven Therapeutics does not accept resumes from recruitment agencies for this position. Recruiters, please do not send resumes to Enliven employees or to the company location. Enliven is not responsible for any fees related to unsolicited resumes.