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Associate Director/Director, Clinical Outsourcing

If interested and qualified, please include Requisition # 2018-326 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.

Position Summary

This position reports to the Head of Clinical Operations.

The Associate Director/Director will be responsible for leading all clinical outsourcing activities related to vendors and clinical trial sites. The successful candidate will develop the vendor oversight strategy for the department and partner with key stakeholders across programs to ensure successful identification, selection and maintenance of vendor, consultant and site contracts. This individual would be responsible for managing third-party relationships and developing best working practices for vendor interaction, pricing, and negotiations.

The successful candidate must be hands-on and comfortable developing procedures, templates, and relationships. The position is expected to build a small team as the organization grows.

Responsibilities

Vendor Selection and Qualification

  • Lead and manage vendor selection process including preparation of RFIs and RFPs
  • Act as the quality liaison for vendor qualification; ensure that sponsor obligations for vendor selection and qualification are followed, including vendor audits, as applicable
  • Build cross-functional relationships with Finance, Legal, and project teams for all scope of work change requests, contract negotiation, and creation of standard budget and SOW templates
  • Negotiate and manage new vendor budgets and SOWs; negotiate and manage change control process, including changes in SOWs and budgets
  • Manage and track purchase orders and current spend, vendor accruals, and projections; and update vendor budget information for annual budget and long-range planning processes
  • Track vendor contract timelines; initiate renewal process as needed
  • Ensure completion of vendor close-out activities and final financial reconciliation at end of engagement

Clinical Trial and Site Budgets

  • Oversee creation and management of site budgets and development of strategic clinical site collaborations
  • Approve clinical patient contract and budget negotiating parameters for CROs
  • Develop cost estimates for study scenarios, forecast full study budgets and keep them up-to-date, working closely with each clinical trial manager; assist clinical trial managers with preparing accruals

Vendor Oversight

  • Oversee and lead supplier governance activities; coordinate executive oversight meetings and monitor key performance indicators (KPIs) and performance metrics; facilitate early escalation of cross-functional vendor issues; partner with study teams to create and manage risk mitigation plans or corrective action plans for vendor performance or quality issues
  • Create and define overall outsourcing strategy, including potential preferred provider relationships, negotiated rate cards, volume discounts, etc.
  • Create and maintain outsourcing/vendor oversight standards and templates

Minimum Qualifications

  • Bachelor's degree with at least 8-10 years of experience with a focus on developing and overseeing clinical budgets, and contracts with clinical outsourcing vendors in the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered)
  • At least 3 years of direct clinical trial and/or vendor oversight experience required; experience negotiating, administering, extending, terminating, and re-negotiating contracts
  • Advanced negotiation skills and vendor selection experience
  • Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
  • Excellent written and verbal communications skills
  • Ability to influence without direct authority
  • Results-driven with demonstrated successful outcomes
  • Ability to handle multiple tasks and priorities in a fast-paced environment with awareness of deadlines
  • Proficient in the use of Microsoft software and development of tracking tools
  • Ability to identify processes needing improvement, and to recommend improvements
  • Strong attention to detail and organization
  • Working knowledge of various contract types and complexity levels
  • Knowledge of clinical development financial principles including cash flow neutrality, payment schedules, costing systems, relational costs

Preferred Qualifications

  • Advanced degree in life science and/or MBA.
  • Experience in clinical drug development including negotiating FIH clinical site budgets/contracts.
  • Experience with drug development in rare genetic diseases or complex indications.

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.
  • Effective Planning - Embedding discipline and thoroughness in our approaches.
  • Leverage Systems & Technology - Uses systems and technology in a facile way. Identifies opportunities to improve processes through systems and technology.
  • Results-Oriented - Drives issues to closure and gets the job done.
  • 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 # 2018-326 in the subject line when emailing resume to: careers@crisprtx.com.

For more information on CRISPR Therapeutics, please click here.