Associate Director, Study Start Up at Eikon Therapeutics

Jersey City, New Jersey, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, BiotechnologyIndustries

Requirements

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 Good Clinical Practice (GCP) guidelines
Analytical, collaborative leader with a passion for solving operational challenges, agile and adaptive mindset, and relentless pursuit of excellence
Ability to develop Study Start-Up timeline and site activation scenarios using industry and company benchmarks, including disease incidence/prevalence, geographic factors, and evolving regulatory/contract cycle times
Ability to facilitate cross-functional stakeholder discussions in a dynamic, fast-paced biopharma environment
Minimum 3 days a week onsite presence in Jersey City, NJ or Millbrae, CA (or more as needed)

Responsibilities

Drive the collection, analysis and summarization of data to generate study start-up insights (e.g., metrics, KPIs, industry benchmarks) for forecasting and accelerating 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 aligned 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 and 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
Lead study, country and site feasibility activities for one or multiple clinical trials, ensuring study forecasts have >80% probability of occurring as planned
Leverage industry benchmarks and cycle times to forecast study timelines and evaluate/improve business processes to accelerate site activation
Directly engage and influence interactions with Clinicians, Study Management, Investigator Sites and support vendor partnerships to deliver operational excellence and high-value outcomes

Skills

Study Start-Up

Clinical Trials

Feasibility Analysis

Site Activation

Timeline Forecasting

Vendor Management

Clinical Operations

Country Feasibility

Site Feasibility

Business Process Improvement

Eikon Therapeutics

Biotech startup developing innovative medicines

About Eikon Therapeutics

Eikon Therapeutics focuses on discovering and developing new medicines in the pharmaceutical industry. The company employs advanced technologies to study biological systems, aiming to identify new drug targets by examining the dynamic aspects of biology rather than just static chemical processes. Their team consists of diverse professionals, including data scientists, chemists, and engineers, which allows them to combine science and engineering to create new therapies that aim to improve and extend life. A key feature of Eikon's approach is their proprietary single-molecule tracking (SMT) platform, which enables rapid visualization of protein movements in living cells. This technology, along with artificial intelligence and automation, allows for precise inventorying of molecular interactions. Eikon Therapeutics targets patients with serious diseases who need effective treatments, generating revenue through the development and commercialization of their therapies.

Hayward, CaliforniaHeadquarters

2019Year Founded

$750.8MTotal Funding

SERIES_CCompany Stage

AI & Machine Learning, BiotechnologyIndustries

201-500Employees

Benefits

401(k) Company Match

Medical (premiums covered by Eikon at 95%)

Dental Insurance

Vision Insurance

Mental Health Support

Unlimited Paid Time Off

Paid Holidays

Life Insurance

Enhanced Parental Leave

Daily subsidized lunch program

Risks

Competition from biotech unicorns like Abogen Biosciences is increasing.

Integrating new clinical-stage assets may delay drug development timelines.

Reliance on SMT technology risks obsolescence from emerging molecular biology technologies.

Differentiation

Eikon uses proprietary single-molecule tracking for real-time protein movement analysis.

The company integrates AI and automation for large-scale molecular interaction studies.

Eikon's diverse team combines expertise in science, engineering, and technology.

Upsides

Growing interest in SMT technology boosts Eikon's drug discovery potential.

Partnerships with AI firms enhance Eikon's drug candidate identification.

Rising demand for precision medicine aligns with Eikon's focus on dynamic biology.

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