Manager, Study Start Up

Eikon Therapeutics; Jersey City (NJ); Sur place; USD 130 000 - 158 000; Plein temps

Avantages offerts par ce poste

401k plan with company matching

Medical (premiums covered by Eikon at

Dental and vision insurance

Mental health and wellness benefits

Weeklong summer and winter holiday tak

Generous paid time off and holiday

Life/AD&D Insurance

Enhanced parental leave benefit

Daily subsidized lunch program when on

Résumé du poste

Eikon Therapeutics in New Jersey seeks an experienced Manager, Study Start Up to improve operational excellence across all phases of clinical development. You will drive feasibility deliverables, coordinate with Clinical Operations, Regulatory, Legal, and other teams, and ensure timely site activation in alignment with ICH/GCP standards.

This role requires onsite presence three days per week in Jersey City.

Qualifications

• Postgraduate degree with 4+ years of experience or Bachelor's with 6+ years in life sciences, healthcare, or related field.
• Experience in the pharmaceutical industry or CRO working with clinical data and development processes.
• Deep understanding of study start up.
• Strong analytical and project management skills.
• Excellent verbal and written communication and collaboration in a matrix organization.
• Experience with Veeva clinical solutions.

Responsabilités

• Improve study feasibility deliverables and provide data-driven recommendations to accelerate clinical trials.
• Support study planning and ensure timely execution of trials in alignment with timelines and standards.
• Collaborate with cross-functional teams to manage site start up activities and country requirements.
• Develop and manage site budgets and contracts as needed.
• Collect and summarize start up data and metrics to inform decisions.
• Create and maintain central tools like investigator databases and site intelligence.

Connaissances

Analytical skills

Project management

Communication skills

Collaboration

Veeva

Formation

Postgraduate degree

Bachelor's degree

Outils

Veeva

Description du poste

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 trialteams to improve operational excellence and efficiency of clinical trial execution in study andsite start up across all phases of Clinical Development activities at Eikon Therapeutics by:Driving study feasibility deliverables and providing data driven recommendations to accelerateclinical trials and Supporting Clinical Development Operations Study Planning: to ensure proper planning and timely execution of all clinical trials in alignment with timelines and qualitystandards.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You are collaborative and passionate about unlocking hidden insights in today’s clinicaloperations 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., ClinicalOperations, Clinical Supply, Legal, Regulatory, Clinical IT, Clinical R&D Process andLearning Management, Clinical Project and Portfolio Management, Clinical QualityAssurance, Clinical Data Management, and Clinical Research) to generate the bestoutcomes 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 informationmanagement 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 ofinformation that informs country allocation, investigator site identification throughactivation, forecasting and planning and contributes to accurate site activationdeliverables.
• Support the Clinical Operations team in the successful execution of clinical trials, fromprotocol concept to Site Activation, complying with ICH / GCP / EMEA guidelines andregulations and SOPs.
• Ensure that selected sites are meeting or exceeding all study start up requirementsleading to Site Activation. This includes gathering and monitoring start up metrics tomeasure against KPIs.
• As required, develop site budgets & contracts, establish achievable finalization targetdates and support the negotiations process leveraging FMV.
• Engage Legal and Financeas deemed necessary.
• Collect and summarize data and study start up insights for Clinical Operations and clinicaltrial 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 demandsand change approach or method to achieve optimal fit-for-purpose solution.
• Excellence in driving results. You persist in accomplishing objectives and exceeding goalsdespite obstacles and setbacks, while also helping others to achieve results.
• Excellent verbal / written communication and collaboration skills and ability to influenceand 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 multipletechnologies.

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 $157,500 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Eikon Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.