Leal Therapeutics is seeking a highly driven individual to lead its Clinical Operations team.

About Leal Therapeutics:

  • Biotechnology company developing novel, precision therapeutics for major diseases of the central nervous system (CNS) with critical unmet needs including ALS, Schizophrenia, and Alzheimer’s disease
  • Core operations in Worcester, MA and Philadelphia, PA
  • Fast-paced startup environment with broad exposure to multiple facets of biotechnology and drug development 
  • Emphasis on cross-functional collaboration within a collegial, learning-oriented environment
  • Continuous career development opportunities and support
  • Ability to have a large impact in a rapidly growing company

Key Responsibilities:

  • Select and manage external CROs, clinical consortia, and study sites for the clinical trials conducted by the Company across multiple programs.

  • Assume responsibility for recruitment strategies and mitigation activities to increase patient randomization, monitoring plans and data management oversight.

  • Participate in protocol and strategy development and Clinical Study Report preparation in combination with internal and external parties

  • Proactively identify potential study issues/risks and implementation of solutions.

  • Prepare metrics and study updates for management, along with cross-functional communication and coordination.

  • Organize and manage internal clinical team meetings, investigator meetings and other trial-specific meetings.

  • Manage clinical trial budget in conjunction with the finance department.

  • Establish procedures to ensure adherence to trial protocols, administrative requirements, and tracking of timeline milestones.

  • Other duties to support clinical trial activities as may be reasonably assigned from time to time. 

Education, Experience, and Qualities Required:

  • Advanced degree preferred (e.g., Pharm.D., M.D., M.Sc.) in a relevant scientific discipline, with 5+ years additional experience required
  • A minimum for 3 years in industry or preclinical drug development required
  • Experience in CNS disorders and early clinical development required
  • Experience with oligonucleotide clinical development preferred
  • Experience with regulatory filings (IND, NDA, CTA) preferred
  • Strong organizational skillset with ability to manage multiple concurrent workstreams
  • Excellent verbal and written communication skills
  • Ability to work collaboratively in a fast-paced, dynamic environment
  • Passion for bringing new therapies to serve patients with unmet medical needs
 

Leal is an equal opportunity employer.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national orientation, veteran status, disability, or any other legally protected status.

 

If interested, please contact Human Resources (hr@lealtx.com) with a brief statement of interest and resume.