Associate Director, Clinical Data Management

Eikon Therapeutics • Jersey City, NJ

2d • Hybrid

About The Position

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. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position We are seeking a highly skilled and experienced Associate Director, Clinical Data Management, to provide strategic leadership and operational oversight for our data management activities. As an Associate Director, you will play a pivotal role in driving the planning, execution, and quality assurance of clinical data management processes, ensuring the integrity, accuracy, and compliance of data throughout the research lifecycle. This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices.

Requirements

• Post Graduate degree with 8+ years of relevant experience or a Bachelor’s degree with 10+ years of relevant experience in a field such as Life Sciences, Biostatistics, Computer Science, or a related discipline.
• Extensive experience in clinical data management, including data collection, database design, and quality assurance.
• In-depth understanding of the biotechnology or pharmaceutical industry and its data management practices, particularly within clinical research.
• Proficiency in relevant data management tools and software, including electronic data capture (EDC) systems and data coding standards.
• Thorough knowledge of regulatory guidelines related to clinical data management and data integrity.
• Demonstrated leadership skills and experience in guiding and mentoring data management teams.
• Strong analytical and problem-solving skills, with the ability to address data-related challenges effectively.
• Excellent interpersonal and communication skills to collaborate seamlessly with cross-functional teams and external partners.

Nice To Haves

• Oncology experience preferred.
• Veeva EDC experience is a plus.

Responsibilities

• Provide strategic direction and leadership for the clinical data management team, ensuring alignment with company objectives and industry best practices.
• Collaborate with cross-functional teams to develop and implement data collection strategies, tools, and systems that meet study goals and regulatory requirements.
• Oversee data quality control processes, including validation, discrepancy management, and reconciliation, to ensure the accuracy and completeness of collected data.
• Lead the design and maintenance of electronic data capture (EDC) systems or databases, ensuring their efficiency and capability to capture essential data elements.
• Ensure adherence to data standards, industry best practices, and relevant guidelines throughout the data management lifecycle.
• Work closely with cross-functional teams, including biostatisticians, clinical researchers, and regulatory experts, to facilitate seamless data integration and analysis.
• Ensure that all data management activities are conducted in full compliance with applicable regulatory standards and guidelines.
• Maintain accurate and comprehensive documentation of data management processes, decisions, and workflows.
• Identify and address complex data management challenges proactively, proposing effective solutions to enhance data quality and operational efficiency.
• Mentor and develop data management team members, fostering their professional growth and ensuring a high level of performance.

Benefits

• bonus and equity compensation
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director