Director, Clinical Operations

CRISPR Therapeutics

Cambridge, MA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 02/15/2021
  • Website: crisprtx.com
  • Company Address: 610 Main Street, Cambridge, MA, 02139

About CRISPR Therapeutics

CRISPR Therapeutics is a leading gene-editing company focused on the development of transformative medicines using its proprietary CRISPR/Cas9 gene-editing platform.

Job Description

Reporting to the Senior or Executive Director of Clinical Operations, this individual will have primary responsibility for clinical trial program oversight within assigned indications including day to day responsibility for trial management. The successful hire will oversee implementation of clinical studies from FIH through commercial marketing authorization in a high quality, timely and cost-effective manner. The successful candidate will ensure that all studies within the program are executed in accordance with US, EU and other governmental regulations as applicable, as well as with appropriate ICH/GCP guidance.  This person will manage cross functional relationships with internal and external stakeholders and will be extremely hands on fostering relationship development with KOLs. This is a high visibility position with great impact potential. 

 

Responsibilities

  • Actively participate in strategic planning activities for assigned programs including budgeting, resource management and vendor identification/management
  • Ensure adequate resources for clinical operations including overseeing operational plans, tactical execution of trials, protocol preparation, report writing, regulatory submissions, etc.
  • Develop, implement and maintain operational procedures and processes within the programs
  • Ensure alignment of activities/decisions affecting all trials within the programs
  • Direct clinical program implementation to meet program timelines
  • Lead clinical projects as required including developing the clinical research strategy, supporting investigator and site selection, identifying, evaluating, selecting CROs and managing CRO performance.
  • Oversee CROs and external vendors on a day to day basis including issue tracking/resolution, timeline/budget management
  • Available for domestic and international travel up to 10%, dependent on program needs
     

Minimum Qualifications

  • BS/BA/BSN – health/science related field preferred
  • Minimum 8-10 years of clinical research experience (including direct trial management experience) with five or more years in a small pharmaceutical or biotech environment
  • Prior success implementing and managing therapeutic drug Phase I/FIH clinical trials, preferably global in nature
  • Prior experience selecting and managing CROs
  • Proven excellence in clinical operations strategy including oversight of multiple trials simultaneously
  • Ability to foster effective relationships with vendors, investigators and colleagues
  • Ability to contribute technical expertise to the various aspects of the clinical trial process.
  • Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR
  • Excellent communication, writing and presentation skills
  • Ability to assess complex issues and propose viable solutions

Preferred Qualifications

  • MS or advanced degree
  • 12+ years of related pharma/biotech experience
  • Experience with cell and gene therapy clinical trials

 

Competencies

  • Adaptability/Flexibility The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands
  • Communication and Teamwork – The ability to effectively express ideas in written and oral context. The ability to work co-operatively with others; the genuine desire to be a part of a team and contribute to organizational and team goals.
  • Customer Partnering – The ability to develop and foster relationships of trust and mutual respect through assuring accessibility and responsiveness.  Demonstrates knowledge of the customer’s function including key issues, processes, metrics, goals, needs and terminology.
  • Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity.
  • Problem Solving – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
  • Relationship Building – Builds and maintains productive working relationships across a diverse spectrum of people.

 

 

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.