Director, Clinical Operations

COMPANY:

The mission of Centessa Pharmaceuticals plc (Nasdaq: CNTA) is to deliver consequential new medicines to patients. The Centessa family includes ten wholly owned, highly specialized companies, with drug discovery and development programs in diverse therapeutic areas. The company’s organizational structure and approach combine the agility and sense of urgency typical of start-up companies with the scale and diversification typical of larger R&D organizations.

SUMMARY:

As Centessa continues to expand its clinical department, we are looking for a Director, Clinical Operations. The Director of Clinical Operations reports to the Vice President of Clinical Development Operations. This position will be empowered to lead study, operational strategy, and planning, and oversee execution of clinical studies for an assigned clinical program(s). Additionally, and most importantly you will use your knowledge and skills to further build an already strong Clinical Operations Department for future success. This is a dynamic leadership role which contributes to program strategy with extensive exposure to Executive Leadership.

 RESPONSIBILITIES:

  • Provide strategic input, management, and oversight of clinical development pipeline across all therapeutic areas, managing several clinical trials as needed.
  • Management and oversight of study from startup to completion, including but not limited to management of enrollment, data cleaning, and aiding in writing clinical study reports.
  • Work with cross functional teams to ensure goals and timelines are in alignment with company objectives.
  • Contributes to study documentation including protocol, informed consent, clinical monitoring plan, EDC, and statistical analysis plan.
  • Identify and mitigate clinical study risks as needed.
  • Facilitate completion of contracts, clinical trial agreements, and budgets.
  • Aids company in determining regulatory strategy and preparing submissions to regulatory authorities (FDA, IRB, EC).
  • Lead the clinical team(s), including in-house team members, Contract Research Organizations (CROs), vendors and other suppliers.
  • Ensure compliance with SOP’s, GCP and ICH guidelines.
  • Leverage existing, and establish new, relationships with Key Opinion Leaders across multiple therapeutic areas to support research & development efforts.

QUALIFICATIONS:

  • Ph.D. or M.S. with 5-10+ years minimum experience in life sciences, pharmaceutical and/or biotechnology industry
  • Previous experience in regulatory submissions to the FDA (preferred)
  • Experience in full scope of clinical trial management of domestic and international Phase 1, 2, and 3 clinical trials across an array of therapeutic areas.
  • Demonstrated ability to organize and manage multiple priorities
  • Cross-functional clinical project management experience (preferred)

POSITION: Full-Time, Exempt

EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.


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