Position
We are currently seeking an experienced leader for the clinical operations role of Director, Clinical Study Management within Clinical Study Management. The Director will manage all aspects of clinical operations study management for assigned Eikon clinical studies, and be responsible for exquisite inhouse execution of all such clinical trials and oversight of requisite clinical vendors. The role will also support the systematic pursuit of optimal performance, efficiency, and quality across the assigned clinical studies. 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. 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 and high-performance delivery of clinical studies.
About You
You are agile of mind, systematic, and a collaborative leader with global oncology clinical development experience and a passion for advancing patient care. You possess a deep understanding of clinical trial regulations, guidelines, 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 delivery of assigned clinical studies.
- Manage clinical study management personnel across assigned clinical studies.
- Ensure that compliance, quality and timeline objectives are met for all assigned studies.
- 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, 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 process workstreams and initiatives.
- 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.
- Set 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
- 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.
- Relevant 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.
- Relevant 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.
- Relevant 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.
- Strategic thinking and high emotional intelligence.
- Process improvement 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.
