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Position:
We are seeking an Associate Director of Study Start-Up to join our Clinical Operations team. In this role, you will support the Eikon Therapeutics Portfolio of studies and lead study start-up activities for one or multiple clinical trials, ensuring efficient and compliant initiation of studies. You will leverage industry benchmarks and cycle times to perform Feasibility and forecast study timelines as well as evaluate/improve business processes / practices to compress the time to Site Activations. You will directly engage and influence interactions with Clinicians, Study Management, Investigator Sites and support vendor partnerships.

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, CA offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You:
You are a collaborative leader with a passion for solving operational challenges, with an agile and adaptive mindset, and relentless in your pursuit of excellence. You excel in the creation and socialization of Study Start Up timeline and enrollment scenarios that inform early forecasts for Study Planning. You leverage both industry and company benchmarks to inform start up modeling. You are detailed oriented and are intimately familiar with the itemization of required activities/tasks that drive study start up at the country and site level. You can translate Protocol particulars into activities that will inform the creation and negotiation of Investigator Grants/Site Budgets. You can facilitate stakeholder discussions that include Study Management, Regulatory Affairs/Operations, Clinical Supply Chain and Site Monitoring functions with the intention of driving to decisions that support the completion of targeted deliverables and desired results. You thrive in an environment that is dynamic and fast paced with a number of moving parts that require thoughtful coordination and orchestration across a diverse group of functional stakeholders

What You’ll Do:

• Manage the study start-up process for clinical trials, including country and site identification & selection, feasibility assessments, and regulatory ethics submissions. 
  
• Drive the collection, analysis and summarization of data to generate study start-up insights (e.g., metrics, KPIs, industry benchmarks, etc.) for Clinical Operations and clinical trial team’s consideration to forecast and accelerate Study Start Up turnaround times. 
• Contribute directly to the development, negotiation and finalization of site contracts & budgets to support rapid site activation.  
• Accelerate the adoption of Veeva clinical technologies to enhance study start-up & coordination with Clinical Operations. 
• Oversee the preparation, submission and collection of study, country & site essential documents in support of IMP shipment to sites. 
• Proactively identify and address potential study & site start-up challenges or bottlenecks to optimize site activation timelines. 
• Collaborate closely with cross-functional teams and key stakeholders (Study Management, Site Engagement & Monitoring Excellence, Clinical Science, Regulatory Operations, Clinical Supply, Legal and Finance) to develop and execute study start-up plans in alignment with project timelines and objectives.  
• Develop and maintain strong relationships with investigative sites, vendors, and internal stakeholders to facilitate study and site start-up activities.
• Ensure compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and internal standard operating procedures (SOPs) throughout the study start-up phase.
• Identify and drive process improvement initiatives to enhance the efficiency and effectiveness of study start-up processes.
• May mentor / coach 1-2 resources to ensure knowledge transfer and upskilling talent.

Qualifications:

• 10+ years of relevant experience with a Bachelor's degree, or 8+ years with a post graduate degree
• Extensive experience in clinical operations or study start-up roles within the biotechnology or pharmaceutical industry. Proven ability to successfully manage multiple clinical trials simultaneously from start-up to close-out.
• Strong knowledge of clinical trial start-up processes, regulatory requirements and industry standards. 
• Clinical budget development and negotiation experience (i.e., GrantPlan) required. Experience with the creation and negotiation of investigator site budget templates and budgets including benchmarking for real world references and application of Fair Market Value (FMV) preferred.
• Excellent project management skills with a focus on delivering results within established timelines and budgets.
• Strong interpersonal and communication skills, with the ability to build effective relationships with internal and external stakeholders.
• Detail-oriented and organized, with the ability to prioritize tasks and adapt to changing priorities in a fast-paced environment.
• Certification in clinical research (e.g., ACRP, SoCRA) or project management (e.g., PMP) is a plus.
• Strong familiarity with Veeva Vault Clinical: Clinical Trial Management System (CTMS) and electronic trial master file (eTMF) systems and supporting study start-up technologies.
• Familiarity with Study/Country/Site Feasibility assessment systems and tools including industry benchmarks for Diseases (eg. WHO, Citeline), Institutional Experience (eg. Trial/Site Trove) and Cycle times (Citeline, KMR) is a plus.
• Experience with scenario modeling and generation of country and site activation forecasts preferred. 

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

• 401k 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​

The expected salary range for this role is $165,000 to $180,500 depending on skills, competency, and the market demand for your expertise.