Manager, Study Start Up

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 currently seeking an experienced, collaborative, detail oriented Manager, Study Start Up expert. In this role you will work with the Senior Director, Study Start Up and the clinical trial teams to improve operational excellence and efficiency of clinical trial execution in study and site start up across all phases of Clinical Development activities at Eikon Therapeutics by: Driving study feasibility deliverables and providing data driven recommendations to accelerate clinical trials and Supporting Clinical Development Operations Study Planning: to ensure proper planning and timely execution of all clinical trials in alignment with timelines and quality standards.

About You

You are collaborative and passionate about unlocking hidden insights in today's clinical operations landscape and relentless in your pursuit of operational excellence.

What You'll Do

Working closely with Clinical Development R&D functions, enhance analytic capabilities to ensure the right questions are being asked and data is being leveraged to drive study feasibility deliverables and provide data driven recommendations to accelerate our clinical trials in study design and study start up

Engage and develop strong working relationships with clinical study teams (e.g., Clinical Operations, Clinical Supply, Legal, Regulatory, Clinical IT, Clinical R&D Process and Learning Management, Clinical Project and Portfolio Management, Clinical Quality Assurance, Clinical Data Management, and Clinical Research) to generate the best outcomes for study and site start up activities

Drive adherence to standards for planning and execution of study start up, country requirements, working in collaboration with Clinical Operations on site information management activities to ensure time critical and high-quality delivery of study specific needs

Partnering with Clinical Operations and clinical trial team, ensure the real time collection of information that informs country allocation, investigator site identification through activation, forecasting and planning and contributes to accurate site activation deliverables

Support the Clinical Operation team in the successful execution of clinical trials, from protocol concept to Site Activation, complying with ICH / GCP / EMEA guidelines and regulations and SOPs

Ensure that selected sites are meeting or exceeding all study start up requirements leading to Site Activation. This includes gathering and monitoring start up metrics to measure against KPIs

As required, develop site budgets & contracts, establish achievable finalization target dates and support the negotiations process leveraging FMV. Engage Legal and Finance as deemed necessary.

Collect and summarize data and study start up insights for Clinical Operations and clinical trial team's consideration to improve Study Start Up turn around times.

Create, manage and archive central start up team tools (e.g., investigator database, clinical site intelligence, etc.) and resources required to support start up team daily operations, communications and records from study assignment to final handoff

Proactively identify and implement best study start up practices, seeking continuous process improvement

Facilitate study start up forum discussions

Support in the development of local workflows to streamline output and deliverables

Support Clinical Development Operations in driving a partnering mindset.

Qualifications

Post Graduate degree with 4+ years of experience or a Bachelor's degree with 6+ years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline).

Solid understanding of US and global regulations and guidelines (e.g., FDA, EMEA, ICH) applicable to clinical development

Significant experience within the pharmaceutical industry or clinical research organization (CRO) working with clinical data and clinical development processes

Deep understanding of complexities of study start up

Strong analytical and project management skills

Able to rapidly adapt to changes in the work environment, manage competing demands and change approach or method to achieve optimal fit-for-purpose solution

Excellence in driving results. You persist in accomplishing objectives and exceeding goals despite obstacles and setbacks, while also helping others to achieve results

Excellent verbal / written communication and collaboration skills and ability to influence and build effective relationships in a matrix organization, including to to ensure timely follow-up, issue resolution, and report updates

Experience with Veeva clinical solutions and familiarity with leveraging multiple technologies.

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 $130,000 to $142,500 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.

Permanent