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Tarsus Pharmaceuticals

Develops FDA-approved ophthalmic therapies

Director – Early Development - Clinical Sciences

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeIrvine, CA, USAHybrid

About the Job

Requirements

  • An advanced degree in sciences, such as a PharmD, MD, or PhD, and deep experience in early clinical development.
  • At least 10 years of biotech or pharmaceutical clinical development experience.
  • At least 8 years of leadership in clinical trial management experience.
  • A track record of leadership and performance-based people management.
  • Expertise with standard operating procedures, Good Clinical Practice, and regulatory and compliance guidelines for clinical trials.
  • Willingness to work hands-on and delve into details.

Responsibilities

  • Create early development clinical plans, program outlines, study designs, and essential clinical study documents.
  • Own early development clinical deliverables and contribute to protocol development, document authoring, data review, study-level problem solving, and execution decisions.
  • Shape clinical plans, including timelines and budgets, and oversee clinical teams.
  • Author and critically review clinical and regulatory documents, including protocols, statistical analysis plans, clinical study reports, investigator brochures, and clinical value dossiers.
  • Lead and oversee training of study investigators on protocols and clinical trial procedures.
  • Conduct research to develop foundational educational material for early development program strategies.
  • Interpret clinical data and support data-driven decisions.
  • Serve as program lead on early development core teams, investigator meetings, and scientific advisory boards.
  • Engage with internal and external stakeholders, including key opinion leaders and regulators.
  • Foster leadership competencies, including innovation, business acumen, outcome orientation, and growth of team capabilities and capacity.
  • Collaborate with Clinical Operations, Regulatory Affairs, Translational Sciences, Biostatistics, Medical Affairs, and other functions to align trial design and ensure scientific rigor and execution.

Desired Qualifications

  • Experience in ophthalmology is preferred; dermatology or infectious disease experience is a plus.

About the Company

Tarsus Pharmaceuticals

Develops FDA-approved ophthalmic therapies

Tarsus Pharmaceuticals develops and markets treatments for eye care and infectious diseases, including XDEMVY (lotilaner ophthalmic solution 0.25%), an FDA-approved eye drop for Demodex Blepharitis. The product is applied as a medicated eye drop to kill Demodex mites and relieve eyelid inflammation. The company differentiates itself with a focused ocular/infectious-disease portfolio, an FDA-approved therapy, and active partnerships to expand its research and reach. Its goal is to address unmet medical needs, grow its product lineup through commercialization, and pursue new indications in eye care and infectious diseases.

Company size
201-500
Company stage
IPO
Headquarters
Irvine, CA
Founded
2017

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