Associate Director, Study Start Up

Position:

We are seeking an Associate Director, Study Start-Up to join our Clinical Operations team. In this role, you will support the Eikon Therapeutics portfolio of studies and lead study, country and site feasibility activities for one or multiple clinical trials, ensuring that study forecasts have a > 80% probability of occurring as planned. You will leverage industry benchmarks and cycle times to perform study, country and site feasibility and forecast study timelines as well as evaluate / improve business processes to accelerate site activation. You will directly engage and influence interactions with Clinicians, Study Management, Investigator Sites and support vendor partnerships to deliver consistent operational excellence and high value outcomes. 

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 an analytical, 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 development of Study Start-Up timeline and site activation scenarios that inform early forecasts for study planning. You leverage both industry and company benchmarks to inform study start-up modeling including disease incidence/prevalence, geographic factors and evolving regulatory and contract cycle time requirements. You can facilitate cross functional stakeholder discussions with Clinical Research & Development to drive operational excellence and achievement of clinical study goals, in a dynamic, fast paced biopharma environment.  

What You’ll Do:

• 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 project team’s consideration to forecast and accelerate Study Start-Up turnaround times. 
• Collaborate closely with cross-functional teams and key stakeholders (Clinical Operations, Clinical, 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 vendors and internal stakeholders to facilitate study, country and site feasibility activities.  
• Proactively identify and address potential study & site start-up challenges or bottlenecks to optimize site activation timelines. 
• 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. 

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. 
• Extensive experience in using internal and external competitive landscape datasets that enable the feasibility assessments associated with clinical trial planning and execution. 
• Power user of Excel with the ability to create and manipulate pivot tables and program algorithms/formulas that enable the running of multiple scenarios with limited effort 
• Proven ability to successfully manage multiple clinical trials in study start-up simultaneously. 
• 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. 
• Mastery of study/country/site feasibility assessment systems and tools including industry benchmarks for diseases (e.g,. WHO, Citeline), Institutional Experience (e.g., Trial/Site Trove) and Cycle times (Citeline, KMR). 
• 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.