Director, Clinical Study Management

About the role

Eikon Therapeutics is seeking a Director, Clinical Study Management to manage all aspects of clinical operations study management for assigned Eikon clinical studies. Key responsibilities include managing clinical study management personnel, ensuring compliance, quality, and timeline objectives are met, collaborating with internal stakeholders, representing Clinical Study Management in process workstreams, and effectively solving problems.

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 to deliver company clinical trial objectives on time, on budget, and with high quality.
• Work with CR&D Functional Area (FA) leads to accelerate enrollment and drive high quality.
• 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.
• Ensure appropriate scientific and operational training for staff members.
• 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.
• Demonstrated working experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry.
• Proven track record of contribution to and delivery of clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals.
• Relevant management experience in a clinical trial setting with the ability to service and collaborate with different CR&D stakeholders in a matrix organization.
• Situational leadership, independence, problem-solving abilities, self-motivation, resourcefulness, and ability to work in a fast-paced team environment.
• 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

• 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.
• Experience in managing budget, resources, headcount, processes (and controls), productivity, quality and project delivery.

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