The posting
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.
About You
You have extensive expertise in clinical data management, including data collection, database design, and quality assurance, along with a deep understanding of industry-specific data management practices. You also have technical proficiency in data management tools and software, comprehensive knowledge of regulatory guidelines, strong leadership skills, analytical acumen, and excellent interpersonal and communication abilities to collaborate effectively with cross-functional teams and partners.
What You’ll Do
- Leadership and Strategy: Provide strategic direction and leadership for the clinical data management team, ensuring alignment with company objectives and industry best practices.
- Data Management Planning: Collaborate with cross-functional teams to develop and implement data collection strategies, tools, and systems that meet study goals and regulatory requirements.
- Quality Control: Oversee data quality control processes, including validation, discrepancy management, and reconciliation, to ensure the accuracy and completeness of collected data.
- Database Management: Lead the design and maintenance of electronic data capture (EDC) systems or databases, ensuring their efficiency and capability to capture essential data elements.
- Data Standards and Compliance: Ensure adherence to data standards, industry best practices, and relevant guidelines throughout the data management lifecycle.
- Team Collaboration: Work closely with cross-functional teams, including biostatisticians, clinical researchers, and regulatory experts, to facilitate seamless data integration and analysis.
- Regulatory Adherence: Ensure that all data management activities are conducted in full compliance with applicable regulatory standards and guidelines.
- Documentation: Maintain accurate and comprehensive documentation of data management processes, decisions, and workflows.
- Problem-Solving: Identify and address complex data management challenges proactively, proposing effective solutions to enhance data quality and operational efficiency.
- Team Development: Mentor and develop data management team members, fostering their professional growth and ensuring a high level of performance.
Qualifications
- 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.
- Data Management Expertise: Extensive experience in clinical data management, including data collection, database design, and quality assurance.
- Industry Knowledge: In-depth understanding of the biotechnology or pharmaceutical industry and its data management practices, particularly within clinical research.
- Technical Proficiency: Proficiency in relevant data management tools and software, including electronic data capture (EDC) systems and data coding standards.
- Regulatory Acumen: Thorough knowledge of regulatory guidelines related to clinical data management and data integrity.
- Leadership Experience: Demonstrated leadership skills and experience in guiding and mentoring data management teams.
- Analytical Skills: Strong analytical and problem-solving skills, with the ability to address data-related challenges effectively.
- Collaborative Approach: Excellent interpersonal and communication skills to collaborate seamlessly with cross-functional teams and external partners.
- Oncology experience preferred.
- Veeva EDC experience is a plus.
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 $178,000 to $215,250 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
