Director, Clinical Study Management (Contract)

Position

We are currently seeking an experienced leader for the clinical operations role of Director Clinical Study Management & Operational Excellence within Clinical Study Management.  The Director will manage all aspects of clinical operations study management, for assigned Eikon clinical programs, and be responsible for exquisite inhouse execution of all interventional clinical trials and oversight of requisite clinical vendors. The role will also support the systematic pursuit of optimal performance, efficiency, and quality across all aspects of clinical study management via a focus on operational excellence. Adherence to Good Clinical Practice (GCP), local and global policies and procedures to conduct high quality, inspection ready studies is essential. The Director is responsible for trial quality and audit responses and completion of CAPAs. They will be a single point of contact for managing clinical trial operationally excellent execution in all its aspects across clinical study phases. The position has multiple stakeholder touch points within Clinical Research & Development (CR&D) staff and important interactions with, inter alia, Quality Assurance (QA), Finance, Regulatory, Clinical Supplies, Business Development and Legal in a matrix-based organization.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City, New Jersey or Millbrae, California offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth and collaboration.

About You

You are agile of mind, systematic, and a collaborative leader with global oncology clinical development experience and a passion for operational excellence and advancing patient care. You possess a deep understanding of clinical trial regulations, guideline, and the principles of GCP, ensuring compliance throughout the clinical trial process.

What You’ll Do

• In collaboration with senior clinical operations management, build and lead inhouse clinical operations study management teams responsible for operationally excellent delivery of assigned clinical protocols and programs.
• Manage clinical study management personnel across assigned clinical protocols and programs.
• Ensure that compliance, quality and timeline objectives are met for all assigned trials.
• Work collaboratively in a matrix organization with all internal stakeholders to deliver company clinical trial objectives on time, on budget and with high quality.
• Work with the CR&D Functional Area (FA) leads, as appropriate, in site management to accelerate enrollment and drive high quality.
• Take responsibility for any assigned clinical trial audits, working closely with the Clinical Quality Assurance group.
• Represent Clinical Study Management in operational excellence initiatives, in the systematic pursuit of optimal performance, efficiency, and quality across all aspects of clinical trial management and execution. Key components of operational excellence, in clinical study management, are: (1) quality and compliance, (2) process optimization, (3) technology integration, (4) risk management, (5) performance metrics, (6) cross-functional collaboration.
• Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve CR&D objectives.
• Responsible for ensuring appropriate scientific and operational training for staff members.
• Serve as a talent magnet and develop, coach, and retain top talent in the clinical program team.
• Sets clear performance standards and holds self and organization accountable for achieving results with flawless execution.
• Embrace metrics and performance standards (KPIs) to drive continuous improvement in execution.

Qualifications

• A post-graduate degree with 12+ years of relevant experience with a Bachelor’s degree or 10+ years of relevant experience with a Master's Degree with a demonstrated working experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry. 
• Significant experience managing international clinical studies and programs in oncology.
• Proven track record of contribution to and delivery of clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations.
• Significant management experience in a clinical trial setting with the ability to service and collaborate with different CR&D stakeholders in a matrix organization.
• Demonstrated situational leadership, independence, problem solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment.
• Significant management expertise should cover management of budget, resources, headcount, processes (and controls), productivity, quality and project delivery.
• A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.
• Strong communication skills requiring proficiency in written and spoken English.
• The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking and high emotional intelligence.
• Strong operational excellence mindset and experience.
• Strong leadership that will attract, motivate, inspire, develop and retain talented staff.
• In addition, leadership skills that enable and drive alignment with the goals, purpose and mission of our company.

The expected hourly range for this role is $108.65 to $118.75 depending on skills, competency, and the market demand for your expertise.