Eikontherapeutics

Director, Clinical Study Management

Millbrae, CA; Jersey City, NJ · Director

Sponsorship not specified$226k-$273kDetected 2 days ago

GCPBusiness DevelopmentOperations ManagementProcess ImprovementClinical TrialsClinical ResearchResearchLeadershipCommunicationCollaborationProblem SolvingGxP

About the role

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases.
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.

Responsibilities

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.
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.
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.
Serve as a talent magnet and develop, coach, and retain top talent in the clinical program team.
Embrace metrics and performance standards (KPIs) to drive continuous improvement in execution.

Requirements

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.
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.
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.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
401k plan with company matching

Compensation

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

Benefits

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

Apply directly at Eikontherapeutics →Create a free account for alerts like this View Eikontherapeutics immigration profile

This listing is sourced directly from Eikontherapeutics's careers page and normalized into a canonical job model.