Associate Director, Clinical Operations in San Diego, CA

$100K - $150K(Ladders Estimates)

Arena Pharmaceuticals, Inc   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech


8 - 10 years

Posted 35 days ago

This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas. Our team in San Diego is growing and we are seeking clinical operations professionals who want to be part of team dedicated to improving patient lives through the development of transformational medicines.

The Associate Director (AD), Clinical Operations will lead the planning, execution and completion of regional/global clinical trials, ensuring alignment of activities with study timelines, budgets, SOPs, GCP and applicable regulatory guidelines. The individual selected for this role will be the key leader in driving a cross-functional clinical trial team to execute on regional/global clinical trials through partnering and collaboration with internal and external team members.

What you'll dive into

  • Demonstrated leadership in the planning, execution and completion of Arena clinical trials – on-time, on-budget and adhering to all regulatory and patient safety requirements
  • Drives the completion of all study-related materials and systems according to timelines and standards
  • Responsible for oversight of study budget, investigator and vendor contracts, budgets and payments; completes accruals on a regular basis
  • Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalates study-related issues, risks and mitigation plans to management in a timely manner
  • Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready
  • Interacts with and participates in strategy discussions with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities
  • Participates in the selection and oversight of Contract Research Organizations (CROs) and vendors
  • May have functional reporting responsibilities or indirect reports (eg, study team members)
  • Assists with clinical operations process development, innovative problem solving and training initiatives

What we expect

  • Bachelor's degree
  • 8+ years of relevant and progressive clinical trial management experience across the full-cycle of drug development (Phase 1 through Phase 3)
  • Leadership excellence as a member of a cross-functional, global clinical trial team
  • Collaboration, teamwork and passion for excellence in clinical operations
  • Demonstrated leadership in the management and monitoring of CRO and investigative sites
  • Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management
  • Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations
  • Motivated to work in a fast-paced, high accountability environment
  • Travel up to 25%

What you'll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people's lives
  • Opportunities to learn and contribute creative solutions
  • Multi-cultural work environment
  • Competitive compensation package (incl. long term incentives)
  • Summer and Winter break provided by the company
  • Company celebrations
  • Public holidays of canton Zug

Valid Through: 2019-10-7