Director, Clinical Study Management

About the role

We are currently seeking an experienced leader for the clinical operations role of Director, Clinical Study Management within Clinical Study Management.

Responsibilities

• 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 compliance, quality and timeline objectives are met for all assigned studies.
• Collaborate with senior clinical operations management, CR&D Functional Area (FA) leads, QA, Finance, Regulatory, Clinical Supplies, Business Development and Legal in a matrix-based organization.
• Represent Clinical Study Management in process workstreams and initiatives.
• Solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions, and timelines.
• 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.
• Ensure appropriate scientific and operational training for staff members.
• Develop, coach, and retain top talent in the clinical program team.
• Set clear performance standards and hold self and organization accountable for achieving results with flawless execution.
• Embrace metrics and performance standards (KPIs) to drive continuous improvement in execution.

Requirements

• 12+ years of relevant experience with a Bachelor’s degree or 10+ years of relevant experience with a Master's Degree.
• 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.
• 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.

Qualifications

• Bachelor’s degree or Master's Degree in relevant field.
• Minimum of 12+ years of relevant experience or 10+ years with a Master's Degree.
• Experience managing international clinical studies and programs in oncology.
• Track record of contributing to and delivering clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations.
• Management experience in a clinical trial setting with the ability to 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.
• Management expertise covering management of budget, resources, headcount, processes (and controls), productivity, quality, and project delivery.
• A thorough understanding of ICH GCP and Global/Regional/Local regulatory requirements.
• Proficiency in written and spoken English.
• Strategic thinking and high emotional intelligence.
• Process improvement mindset and experience.
• Strong leadership that attracts, motivates, inspires, develops, and retains talented staff.

Benefits

• 401(k) plan with company matching
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
• Mental health and wellness benefits
• Weeklong summer and winter holiday shutdowns
• Generous paid time off and holiday policies
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
• Enhanced parental leave benefit
• Daily subsidized lunch program when on-site

Pay

The expected salary range for this role is $226,000 to $273,000 depending on skills, competency, and the market demand for your expertise.

Schedule

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.