Eikon Therapeutics
Associate Director, Process Management - Clinical R&D
Eikon Therapeutics, Hayward, California, us, 94557
Position
We are seeking a dynamic and 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 will require a minimum of 3 days a week of onsite presence in either of our California or New Jersey offices.
About You
The ideal candidate for the Associate Director, Process Management – Clinical R&D role is a collaborative and dynamic individual with a strong background in developing and executing robust business processes to improve efficiency, optimize resources, and reduce errors and compliance risks. They have experience in engaging and organizing subject matter experts and cross-functional groups to identify gaps and inefficiencies and taking action to bridge the gap through process optimization. Additionally, they have a strong background in the end-to-end clinical drug development process.
What You’ll Do
Lead project teams through the creation, review, and maintenance of procedural documents (e.g., Standard Operating Procedures, policies, job aids), 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 to deliver efficiencies and mitigate compliance risks.
Identify gaps and inefficiencies to current state business processes and opportunities for improvement.
Implement tools required to collect and measure relevant data, identify key performance indicators (KPI), and produce a data-driven analysis of critical functions.
Define and evaluate metrics to monitor effectiveness of existing business processes.
Partner with Business Process Owners and IT System Owners in the design, implementation, and release management of clinical systems, i.e., Clinical Trial Management System, electronic Trial Master File, etc.
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 in order to identify and prioritize core business processes based on strategic importance, regulatory requirements, and impact on business operations.
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; develop documentation, tools, and training to support adoption.
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.
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 $122,000 to $190,000 depending on skills, competency, and the market demand for your expertise.
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We are seeking a dynamic and 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 will require a minimum of 3 days a week of onsite presence in either of our California or New Jersey offices.
About You
The ideal candidate for the Associate Director, Process Management – Clinical R&D role is a collaborative and dynamic individual with a strong background in developing and executing robust business processes to improve efficiency, optimize resources, and reduce errors and compliance risks. They have experience in engaging and organizing subject matter experts and cross-functional groups to identify gaps and inefficiencies and taking action to bridge the gap through process optimization. Additionally, they have a strong background in the end-to-end clinical drug development process.
What You’ll Do
Lead project teams through the creation, review, and maintenance of procedural documents (e.g., Standard Operating Procedures, policies, job aids), 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 to deliver efficiencies and mitigate compliance risks.
Identify gaps and inefficiencies to current state business processes and opportunities for improvement.
Implement tools required to collect and measure relevant data, identify key performance indicators (KPI), and produce a data-driven analysis of critical functions.
Define and evaluate metrics to monitor effectiveness of existing business processes.
Partner with Business Process Owners and IT System Owners in the design, implementation, and release management of clinical systems, i.e., Clinical Trial Management System, electronic Trial Master File, etc.
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 in order to identify and prioritize core business processes based on strategic importance, regulatory requirements, and impact on business operations.
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; develop documentation, tools, and training to support adoption.
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.
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 $122,000 to $190,000 depending on skills, competency, and the market demand for your expertise.
#J-18808-Ljbffr