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Process Management Director
4 weeks ago
About Eikon Therapeutics
Eikon Therapeutics is a biopharmaceutical company pioneering innovative technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Our discovery platform is built on groundbreaking innovations from our founders, culminating in the creation of microscopes that enable real-time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Job Summary
We are seeking a strategic Associate Director, Process Management to create and drive business process optimization and continuous improvement in support of the growth and organizational effectiveness of our Clinical Research & Development team. This role requires a minimum of 3 days a week of onsite presence in either of our California or New Jersey offices.
About the Role
- Lead project teams through the creation, review, and maintenance of procedural documents, process maps, and personnel qualification strategies.
- Partner with Business Process Owners to ensure processes integrate with the end-to-end clinical drug development process and deliver efficiencies and mitigate compliance risks.
- Identify gaps and inefficiencies in current state business processes and opportunities for improvement.
- Implement tools to collect and measure relevant data, identify key performance indicators, and produce a data-driven analysis of critical functions.
- Define and evaluate metrics to monitor the effectiveness of existing business processes.
- Partner with Business Process Owners and IT System Owners in the design, implementation, and release management of clinical systems.
- Collaborate with Business Process Owners, IT System Owners, functional leaders, subject matter experts, and Clinical Quality Assurance to define applicable compliance and business requirements.
- Develop and implement strategies to ensure ongoing inspection readiness for clinical trials.
- Support GCP audits and inspections by regulatory authorities and business partners.
- Collaborate in the development and delivery of training programs associated with the introduction of new or updated operational procedures or deployment of new or modified clinical systems.
- Remain informed about changes in regulations, industry standards, and best practices.
Qualifications
- 10+ years of clinical drug development experience with a Bachelor's degree.
- Experience in the biotechnology or pharmaceutical industry is required.
- In-depth knowledge of ICH-GCP, EMEA guidelines, and other relevant regulations and guidelines.
- Demonstrated ability to lead and influence change in process development and system implementation.
- Ability to collaborate effectively with cross-functional teams and subject matter experts.
- Proven ability to synthesize information from multiple sources and make risk-based decisions.
- Experience with Veeva Quality Vault and Veeva Clinical Platform is preferred.
- Excellent written, organizational, and interpersonal skills.
- Ability to work onsite at least 3 days a week.
Benefits
- 401k plan with company matching.
- Medical, dental, and vision insurance.
- Mental health and wellness benefits.
- Weeklong summer and winter holiday shutdowns.
- Generous paid time off and holiday policies.
- Life/AD&D Insurance and optional supplemental employee-paid life/AD&D policies.
- Enhanced parental leave benefit.
- Daily subsidized lunch program when on-site.
Compensation
The expected salary range for this role is $122,000 to $190,000 depending on skills, competency, and market demand for your expertise.
Eikon Therapeutics is an Equal Opportunity Employer
We are proud to be an equal opportunity employer and will consider all qualified applicants for employment.
COVID-19 Vaccination Policy
In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA-approved COVID-19 vaccines. If you believe that you are exempt from this requirement under an applicable law or regulations, please contact the Company's Human Resources group.
