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Director/Sr. Director, Clinical Operations

If interested and qualified, please include Requisition # 2016-141 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.

Position Summary

The Director/Senior Director, Clinical Operations will build and lead the function by implementing clinical studies and research programs for our novel gene editing therapies at high quality and in a timely and cost-effective manner.  The successful candidate will ensure that all studies are executed in accordance with US, European and other government regulations as applicable, as well as with appropriate and ICH/GCP guidance. The position directly oversees the Clinical Operations group, including Clinical Trial Leaders/Managers (CTL’s/CTM’s), Clinical Research Associates (CRA), and other staff. Line management responsibilities include setting (together with senior management) the overall vision and structure of clinical operations, hiring talented staff, setting objectives, ensuring and organizing resourcing, monitoring and managing performance, coordinating/organizing activities within the clinical operations group and ensuring alignment with the broader organization. This position will also oversee clinical QA, clinical trial vendor selection and management to ensure that projects are efficiently resourced and effectively managed.

Responsibilities 

The successful candidate will be a confident leader, with significant understanding of the principles of clinical research. This person will have high attention to detail, significant prior success in building and leading a clinical operations function, with specific experience in Phase 1/First in Human trials, and preferably in Cell and Gene Therapy products or Orphan disease, together with a passion and sense of urgency for developing important new medicines for patients with devastating diseases.

Responsibilities include:

  • Together with Senior Management, establish the overall structure of the Clinical Operations function
  • Actively participate in strategic planning activities and translate strategic decisions into operational plans
  • Assess organizational needs and build a scalable infrastructure to support Clinical programs
  • Ensure adequate resources for clinical operations, including operational plans, tactical execution, protocol preparation, report writing, regulatory submissions, etc.
  • Develop, implement and maintain operational processes and systems to allow cost-effective and timely execution of high-quality clinical studies in accordance with all applicable regulations
    • Ensure the appropriate implementation of clinical infrastructure including SOPs, policies and cross-functional communication and interaction
    • Ensure consist operational approach across multiple clinical studies and development programs
  • Provide operational input into integrated development plans and study protocols, as required
  • Direct clinical program implementation to meet program timelines
  • Lead clinical projects (as Clinical Trial Leader) as required, including developing the clinical research strategy, supporting investigator and site selection, identifying, evaluating, selecting CROs and managing CRO performance
  • Assist in development of US cost estimates and budgets for clinical trials
  • Hire, supervise and develop staff within Clinical Operations, including Clinical Trial Leaders/Managers and Clinical Research Associates, and provide support, including analyzing and resolving issues relating to study design, protocol execution and compliance
  • Manage the functional area budgets; provide senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner
  • Must be available for domestic and international travel up to 20%, dependent upon program needs

Minimum Qualifications

  • Bachelors degree and 10 years of clinical research experience with five or more years of experience in a pharmaceutical or biotech environment in the development & management of clinical operations function with direct management of staff; previous field experience as a CRA preferred
  • Prior success implementing and managing therapeutic drug Phase 1/FIH clinical trials and international, preferably European, clinical trials, including clinical supply and document control functions, timelines and budgets
  • Prior experience selecting and managing Clinical Trial CROs
  • Proven excellence in clinical operations strategy; experience with developing, implementing, and measuring the impact of clinical operations tools across multiple projects
  • Experience developing and implementing functional and cross-functional SOPs, Processes and Clinical Quality (cQA) activities
  • Thorough knowledge of FDA and European regulatory requirements and ICH/GCP guidelines
  • Effective stakeholder management and ability to proactively navigate ambiguity to ensure timely execution of strategy
  • Demonstrated ability to build, coach, motivate and supervise a high performing team in a growing company, including ability to clarify roles and responsibilities

Preferred Qualifications

  • Masters or Doctoral degree or equivalent in a scientific discipline
  • 12+ years of related biotech/pharma experience
  • Experience with Cell and Gene Therapy Clinical Trials
  • Experience with clinical development in hematology, specifically Sickle Cell Disease or Beta-thalassemia

Competencies

  • Building a Successful Team – Building an effective group that contributes to the larger success of the organization through setting clear expectations, providing context and building commitment.
  • 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. Proactively works with customer to address issues.
  • Effective Planning – Embedding discipline and thoroughness in our approaches.
  • Job Knowledge – Achieves and maintains technical and professional proficiency related to current job position and areas of expertise.
  • Leverage Vendor Resources – Understands vendor needs, interests and full range of offerings and maximizes benefits to the Company. Manages vendors effectively.
  • Risk and Compliance Management – Demonstrates great attention to detail and assures appropriate output. Identifies situations where risk may arise and implements risk mitigation processes and strategies.

If interested and qualified, please include Requisition # 2016-141 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.