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 disease. 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 of proteins as drug targets.
We are currently seeking a highly experienced and innovative leader for the role of Executive Director, Data Management. This is not your standard clinical data management role. This position is highly visible and of significant impact to the company. This position will lead and drive transformational initiatives in partnership with the business and leverage technical and functional expertise to manage successful execution of the clinical data management strategy. The position will collaborate to drive innovative use of technology, data and create value and superior experiences for Eikon colleagues and exquisite delivery of high-quality clinical data to support all interventional clinical trials, whether managed through inherited external vendors or a growing and highly talented internal staff.
What You’ll Do
- Provide leadership to Clinical Data Management: Build the best team and chart the course. This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority clinical data management projects and associated study deliverables.
- Responsible for developing and implementing a strategic vision for the Clinical Data Management team and overseeing all activities pertaining to end-to-end clinical data management activities from study start-up through close-out, reporting and archiving for Eikon’s clinical trials. This includes integration of machine learning (ML), robotic process automation (RPA) and artificial intelligence (AI) into workflows.
- Accountable for developing and leading a highly functional and scalable clinical data management organization that consistently delivers business objectives on time with integrity, and high quality to support Eikon’s clinical development pipeline.
- Drives a culture of collaboration and continued improvement and works closely with other functional leads to maintain cross-functional operational excellence.
- Provide oversight for the development and quality control of data management documents including data management plans, data validation and specifications.
- Facilitate the development of key data and metrics reports for data cleaning and review and lead the development and implementation of clinical database management SOPs, work instructions, standards and best practices.
- Champion appropriate clinical data management methodological approaches, driving the institution of best practices on the planning, execution, and interpretation of clinical studies, while also encouraging the rigorous development of novel methodologies with the potential to improve the drug development process.
- Ensure compliance with SOPs, GCP, ICH guidelines, and other established guidelines of national and international regulatory authorities.
- Master’s degree, or equivalent, combined with a proven track record of contribution to and delivery of clinical data management that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations.
- 12+ years of experience in clinical data management gained from working at recognized clinical data management suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
- Demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Ability to negotiate project timelines across programs with competing priorities given constraints; manage and coordinate limited resources to produce high quality deliverables within timelines.
- Ability to partner with Clinical Development leaders and internal stakeholders to establish clinical data management best practices, SOPs, standards and processes regarding conduct of clinical trials, data analysis and interpretation.
- Ability to assess needs for changing processes, and to recommend and implement new infrastructure and/or processes to improve efficiency and quality.
- Demonstrate a high level of understanding with the design and development of electronic Case Report Forms (eCRFs), clinical databases and other methods of capturing and transferring data, clinical database development tools, reporting tools, and the development process in support of clinical research.
- Strong sense of urgency and cross functional stakeholder focus. Ability to work independently, possess excellent communication skills and interact with clinical study teams, including CROs/vendors where applicable, to integrate study team requirements into all deliverables.
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 $248,000 to $285,000 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.
In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to have received both an FDA-approved primary vaccine series and at least one booster vaccine against COVID-19 as of their start date. If you are unable to meet this requirement due to a disability or serious medical condition, or due to a sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.