Reporting to: Senior Director, Clinical Operations

Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite you to be a part of a patient-focused company developing potential new treatments that could dramatically improve the lives of patients with limited to no current treatment options? If yes, we encourage you to share with us your aspirations and career goals.

Our company is focused on restoring healthy immune system function by developing novel therapeutics to treat chronic neutropenic disorders, including WHIM syndrome, a rare primary immunodeficiency. We are advancing a novel, late-stage clinical candidate, mavorixafor, that we believe has the potential to become a new standard of care for patients with these disorders. We know that developing innovative, new medicines is challenging, and we invite new colleagues who share our values and commitment to join us in achieving our mission.

This opportunity will …

• Align with your values and grit, and passion for innovative science.
• Leverage your deep knowledge of Clinical Operations to support our innovative science and allow you to have a major impact on our mission to support our patients.
• Offer a collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.
  
  

Accountabilities And Responsibilities

The Associate Director, Clinical Operations, plays a crucial role in managing and executing high-quality clinical trials on time and within budget. This position combines operational management and oversight, with an overall focus on study management.

• Accountable for study planning, management, and oversight
• Monitor study progress, data collection, and quality for all clinical trials within their remit, inclusive of oversight of third-party vendors.
• Identify potential risks and issues in clinical trials, develop mitigation strategies, and escalate as necessary.
• Oversee the budget and provide input to forecasting and managing study costs, negotiating contracts, and ensuring payments.
• Collaborate with internal cross-functional counterparts to oversee the performance for all activities delegated to third party vendors, including escalation of issues to governance committees and to senior management when warranted.
• Ensure trial(s) is conducted in compliance with applicable local regulations, as well as industry best practices and ethical guidelines!
• Provide input to regulatory and ethics submission and queries.
• Drive and participate in protocol and study-related document development.
• Develop and build strong working relationships with CROs, key investigators, and other staff/vendors.
• Maintain primary, when applicable, and timely contact with clinical trial site staff.
• Develop relationships with clinical site staff and investigators, as appropriate, to ensure optimal sponsor-site relationships and study conduct.
• Lead planning and conduct of investigator’s meetings and site engagement and training opportunities.
• Provide expertise on related Clinical Operations documents and publications as needed.
• Support the development of best practices and functional SOPs.
• May manage and/or mentor other Clinical Operations staff.
  
  

Requirements: Proven Experience, Skills, and Education:

• Bachelor’s degree required; Advanced degree preferred.
• 8-10 years of relevant Clinical Operations experience in the biotech/pharmaceutical industry.
• Experience with NDA and BLA submissions as well as FDA regulations and other international regulatory agencies.
• Knowledge and ability to implement Clinical Operations concepts and best practices.
• Proven experience with successful management and interaction with CROs, vendors, and other external clients.
• Proven track record of managing multiple and complex studies across early and/or late phase drug development.
• Ability to effectively represent functional expertise at the cross-functional team level.
• Understand the concepts and implementation of budget development.