Kymera Therapeutics

Head of Clinical Operations (Senior Director to VP)

Job Description:

The Head of Clinical Operations will lead the implementation and execution of multiple clinical programs in accordance with Kymera company goals. The Head or Operations will participate in clinical strategy development and will be responsible for all operational activities associated with start-up, conduct and data delivery of clinical trials in accordance with ICH/GCP guidelines. They are accountable for clinical sourcing strategy including the selection and governance of clinical vendors such as CROs as well as hiring and development of internal Kymera clinical team members. Reporting to the Chief Medical Officer, the Head of Operations will play a key role in the selection of clinical investigators and sites in North America, Europe and Asia across several indications.

Responsibilities:

  • Establishes and maintains operational direction for clinical programs including clinical timelines, enrollment targets and budgets
  • Leads clinical site feasibility, qualification, contracting and performance management processes
  • Selects clinical vendors beginning with proposal process and oversees productive relationships throughout clinical trial conduct
  • Hires, coaches and develops internal clinical staff to optimize expertise in clinical operations, data management and clinical programming
  • Participates in development of key documents including clinical development plans, protocols and consent forms
  • Establishes quality standards and ensures compliance/audit-readiness of clinical programs
  • Tracks and proactively reports on any changes to clinical programs through identification of key milestones and risk indicators
  • Builds and invests in internal and external relationships with key stakeholders

Qualifications:

  • Proven experience hiring and developing clinical operations team members
  • Proven history of successfully selecting and managing external vendors
  • Excellent project management skills including timeline and budget management
  • Detailed knowledge of ICH, GCP and FDA guidelines for conduct of global clinical trials
  • Experience with early phase and global trials as well as regulatory submissions (IND, NDA)
  • Early stage company experience preferred
  • Excellent communication skills with fluency in written and verbal English

Key Attributes:

Enthusiastic, goal-driven, collaborative and team-oriented, open-minded, creative, self-aware, excellent communication skills, proven strategic and people leadership skills

Education/Experience:

  • 10+ years experience in clinical operations management in pharmaceutical or service provider setting. Therapeutic experience in oncology and/or immunology preferred
  • Bachelor’s or advanced degree in science-based field

Email us at careers@kymeratx.com to tell us why you think you’d be a good fit for this position.