Associate Director, Process Management - Clinical R&D

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Job description

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 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 or 8+ years experience with post graduate 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.

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 be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.

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.

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