Director, Business Operations & Analytics

DIRECTOR, BUSINESS OPERATIONS & ANALYTICS

Position Summary:

The Director of Business Operations & Analytics is a leadership position within Global Blood Therapeutics' Development team. In close collaboration with the Head of Clinical Operations, this role will influence and facilitate Developments' oversight strategy and execution of GBT's clinical programs. The Director of Business Operations & Analytics is responsible for the oversight and process improvement of Development operations, oversight and management strategies, resourcing and systems (e.g. CTMS, eDC, data visualization etc.). This position requires detailed management of timelines, the ability to multitask, and to adapt to rapid change within a complex environment.

Essential Duties and Responsibilities:

• Works with Development cross-functional teams to understand business needs and priorities
• Reviews business and operational processes and procedures to make recommendations to support operational enhancements
• Engage stakeholders to understand and diagnose business problems and recommend appropriate courses of action
• Identifies opportunities for continuous improvement and adopt emergent relevant methodologies, tools and applications to ensure fit-for-purpose and impactful approaches
• Analyzes data and information to identify business opportunities
• Enhances workflow and cross-functional collaboration
• Queries data and builds analytical models that evaluate data and reports actionable information to support strategic decision making
• Supports systems initiatives through evaluation, documentation, and recommendation of systems requirements and operational impact
• Provides subject matter expertise to perform pre- and post-implementation due diligence for systems initiatives
• collaborates with Development teams to implement continual process improvement activities/measures
• Collaborates with Development, IT and QA teams to identify technology infrastructure needed to support quality improvement programs
• Oversight and implementation of study management infrastructure and systems
• Develops and evaluates data/metrics/key performance indicators to support management of Development programs
• Implementation and maintenance of resource algorithms to support growth and resource strategy for Development organization
• Collaborates with Development and other cross-functional teams to identify process risks and mitigation strategies
• In collaboration with QA, assist in the preparation and presentation of annual quality trending reports
• Perform routine review of quality systems and processes to ensure adherence to company standards
• Lead initiatives within Development organization
• Troubleshoots clinical trials and activities
• Provides leadership and strategy in line with global strategic objectives

Qualifications:

• Clinical Operations/Development leader with greater than 10+ years of international Phase 1-4 trial experience in the pharmaceutical/biotech industry
• Bachelor's degree required. RN/PA with professional clinical experience, and/or master's degree or higher in health-related science or equivalent preferred
• She/he will have:
  • Strong communication skills (verbal and written); effective in interaction cross-functionally and with senior management
  • Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
  • Comfortable executing on multiple projects independently
  • Visionary and passionate about implementing innovation within clinical development
  • An intense drive and organizational expertise are necessary to manage the diverse group of functional activities
  • Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP
  • Knowledge and experience with managing complex clinical development situations
  • GCP inspection preparation and support experience, both clinical site and sponsor GCP inspections
  • Excellent judgment and problem-solving skills
  • Provide direct reports with appropriate coaching, mentoring and development
  • Ability to think creatively, strategically and tactically
  • An entrepreneurial spirit with can do attitude, commitment to teamwork, and initiative
  • Demonstrated ability to lead teams or task forces in the development of Development Operations processes, plans and tools
  • Excellent interpersonal skills
  • Ability to work on problems of diverse scope and extremely complex in nature which may cross many functional areas
  • Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
  • Familiarity with common Clinical Development metrics, industry-standard performance levels and the implementation of continuous process improvement methodologies (such as Six Sigma, Lean/Kaizen, Quality Function Deployment, etc.)
  • Understanding of multiple regulatory agency requirements as they relate to GBT clinical trials
  • Understanding of vendor management and vendor audits
  • Experience with IT systems commonly used in Clinical Development

Fit with GBT culture:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Values-based leadership consistent with GBT's Core Values
• Excitement about the vision and mission of GBT
• Flexibility
• Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.