Associate Director, Process Optimization
5 days ago
Eikon Therapeutics is a pioneering biopharmaceutical company that leverages cutting-edge technology to develop novel treatments for life-threatening diseases. Our discovery platform combines innovative chemistry, engineering, computation, and biology to unlock previously inaccessible classes of proteins as drug targets.
Job SummaryWe are seeking a highly skilled Associate Director, Process Management to drive business process optimization and continuous improvement within our Clinical Research & Development team. This role requires a minimum of 3 days a week of onsite presence in either our California or New Jersey offices.
Key Responsibilities- Lead project teams in creating, reviewing, and maintaining 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, delivering efficiencies and mitigating 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 (KPIs), and produce data-driven analysis of critical functions.
- Define and evaluate metrics to monitor the effectiveness of existing business processes.
- Collaborate with Business Process Owners, IT System Owners, functional leaders, subject matter experts (SMEs), 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/updated operational procedures or deployment of new/modifications to clinical systems.
- 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.
- Competitive salary range: $122,000 to $190,000.
- Bonus and equity compensation.
- Generous benefit programs, including 401k plan with company matching, medical, dental, and vision insurance, mental health and wellness benefits, weeklong summer and winter holiday shutdowns, 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.
Eikon Therapeutics is an equal opportunity employer and welcomes applications from qualified candidates. We are committed to creating an inclusive and diverse work environment.
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