Position

We are seeking a physician with a strong clinical background and a passion for drug development to join our Clinical Development team to serve as a Study Responsible Physician, Senior Director, Clinical Research. In this role, you will play a pivotal part in advancing our oncology and/or non-oncology pipeline by providing medical expertise, leadership, and operational oversight for a clinical development study(ies).

About You

You are a highly accomplished professional who excels in the development and execution of clinical projects. As a key member of the cross-functional Development Teams and the Clinical Study Teams, you will employ your expertise in clinical development to advance new therapies to patients in need. Your dedication to scientific rigor and meticulous attention to detail is evident in all your work. With a deep passion for creating important new medicines, you are committed to advancing the field of medical research and improving patient outcomes.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey or California offices to ensure effective collaboration and high-quality execution of your clinical work.

What You’ll Do in partnership with your Manager

• Design and conduct early-stage or late-stage clinical development trials as needed, including, but not limited to assessing clinical safety and efficacy data, performing medical monitoring, and be responsible for other study-related clinical activities.
• Interpret reports, and prepare oral and written results of product research.
• Be proactive in fulfilling your responsibilities and pay particular attention to quality and accuracy of work as well as timeliness of deliverables.
• Collaborate closely with relevant functions within Eikon including discovery, translational and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, and regulatory personnel.
• Work closely with functional partners (Clinical Science, Data Management, Clinical Operations, Biostatistics) to ensure an integrated approach to flawless execution and systematic oversight of study protocol(s) in clinical development.
• Work closely with functional partners to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.

Qualifications

• MD or DO degree with significant experience in Oncology.
• Minimum of 5-7 years of clinical experience, including 3+ years in drug development.
• Experience in clinical practice with direct patient care.
• Proven track record in leading clinical trials, including medical monitoring of early and late stage clinical trials.
• In-depth knowledge of clinical research methodologies, GCP, and regulatory requirements.
• Ability to work effectively in a matrixed environment.
• Strong analytical, organizational, and problem-solving skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Passion for clinical trials and improving patient outcomes.
• Experience with IND and/or NDA/BLA filings is preferred.

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 $270,000 to $294,500 depending on skills, competency, and the market demand for your expertise.

Position

The Lab Data Manager will be responsible for timely and high-quality management of local lab reference ranges supporting the Eikon portfolio including the loading of Lab Normal Ranges (LNR) within the EDC system and the management of LNR issue tracking and health status of a particular lab, site or study.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City, NJ office or our Millbrae, CA 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 a driven individual that focuses on detail.  An expert in data management and a strong collaborator.

What You’ll Do

• Review and quality control (QC) the reference ranges provided by the site or, if applicable, other Eikon functional groups.
• Create lab normal range import file and uploads it into EDC local lab module.
• Be responsible for LNR issue tracking and maintaining health status at lab, site, and study level for communication to Data Management leadership or other cross functional teams.
• Manage local lab range units within the EDC system including change control process.
• Collaborate with Data Management colleagues, other Eikon functions, and study site personnel to continuously improve the collection and loading of LNR data.
• Provide LNR training for Data Management and other Eikon functions as required.
• Be responsible for the creation and maintenance of any Data Management owned controlled documents and provide SME knowledge to any cross functional controlled documents related to LNRs.
• Act as the LNR SME for Health Authority inspections and audits.
• Serve as a primary point of contact for internal and external study team members regarding local lab reference ranges.
• Serve as a backup for medical coding activities.

Qualifications

• 6+ years of experience with a Bachelor's degree in a health related field (Chemistry, Nursing, etc.); or 4+ years of experience with a post graduate degree
• Proven experience in clinical data management gained from working at recognized clinical data management suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic (Oncology experience will be preferred) and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
• 3+ years of experience focused on the collection and maintenance of local lab reference ranges within standard clinical data management systems.
• Expertise with Lab analytes collected and tested in Oncology clinical trials is preferred.
• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.
• Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management and local lab ranges.
• Strong knowledge and experience of EDC systems (Veeva CDMS preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection.
• Experience using a Local Lab Module within a standard EDC system is required.
• Strong project management, metrics analysis and reporting methodologies experience.
• Excellent oral and written communication skills and able to communicate effectively with senior management and cross-functional teams.
• Good knowledge of CDASH/CDISC (CDASH CRF Library implementation experience is preferred).
• Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)].
• Medical Coding experience is a plus.

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 $104,000 to $114,000 depending on skills, competency, and the market demand for your expertise.

Position

As a Senior Medical Writer 2, you will play a pivotal role in translating complex scientific and medical information into clear and concise written materials. Operating in a dynamic and collaborative environment, you will contribute to the development of various documents that support our research, clinical trials, and regulatory activities.

About You 

The ideal candidate for this position should possess strong writing and communication skills, with the ability to effectively convey complex scientific concepts in a clear and concise manner. Exceptional attention to detail and a commitment to producing accurate and high-quality written materials are essential. Proficiency in Microsoft Office Suite and familiarity with scientific writing tools is important, and the candidate should be capable of thriving in a fast-paced and collaborative work environment. While knowledge of clinical research, regulatory requirements, and biotechnology is advantageous, it is not required.

What You’ll Do

• Document Preparation: Create a wide range of medical and scientific documents, including clinical study protocols, investigator brochures, regulatory submissions, and scientific publications.
• Content Development: Collaborate closely with cross-functional teams to collect and interpret data, ensuring accuracy and relevance in written materials.
• Regulatory Compliance: Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards.
• Literature Review: Conduct comprehensive literature reviews to support the development of evidence-based documents.
• Data Interpretation: Proficiently interpret and summarize complex scientific data and clinical trial results for various audiences.
• Editing and Proofreading: Review and edit documents for grammar, clarity, and consistency while maintaining a high level of accuracy.
• Collaboration: Collaborate closely with scientists, clinical teams, and regulatory affairs professionals to align written materials with project goals and timelines.
• Mentorship: Provide guidance and mentorship to junior medical writers, fostering their professional growth and development.

Qualifications

• PhD with 3 years of experience or a Master’s degree with 6 years of experience or a Bachelor's degree with 8 years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline). 
• Strong writing and communication skills, with the ability to effectively convey complex scientific concepts in a clear and concise manner.
• Must have hands on experience with independently drafting CSRs, ICFs, IBs, Protocols, and/or CTD modules
• Exceptional attention to detail and commitment to producing accurate and high-quality written materials.
• Proficiency in Microsoft Office Suite and familiarity with scientific writing tools.
• Capability to thrive in a fast-paced and collaborative work environment.
• Knowledge of clinical research, regulatory requirements, and biotechnology is advantageous but not required.

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 $148,000 to $161,500 depending on skills, competency, and the market demand for your expertise.

Position

We are currently seeking an experienced leader for the clinical operations role of Director Clinical Study Management & Operational Excellence within Clinical Study Management.  The Director will manage all aspects of clinical operations study management, for assigned Eikon clinical programs, and be responsible for exquisite inhouse execution of all interventional clinical trials and oversight of requisite clinical vendors. The role will also support the systematic pursuit of optimal performance, efficiency, and quality across all aspects of clinical study management via a focus on operational excellence. Adherence to Good Clinical Practice (GCP), local and global policies and procedures to conduct high quality, inspection ready studies is essential. The Director is responsible for trial quality and audit responses and completion of CAPAs. They will be a single point of contact for managing clinical trial operationally excellent execution in all its aspects across clinical study phases. The position has multiple stakeholder touch points within Clinical Research & Development (CR&D) staff and important interactions with, inter alia, Quality Assurance (QA), Finance, Regulatory, Clinical Supplies, Business Development and Legal in a matrix-based organization.

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

About You

You are agile of mind, systematic, and a collaborative leader with global oncology clinical development experience and a passion for operational excellence and advancing patient care. You possess a deep understanding of clinical trial regulations, guideline, and the principles of GCP, ensuring compliance throughout the clinical trial process.

What You’ll Do

• In collaboration with senior clinical operations management, build and lead inhouse clinical operations study management teams responsible for operationally excellent delivery of assigned clinical protocols and programs.
• Manage clinical study management personnel across assigned clinical protocols and programs.
• Ensure that compliance, quality and timeline objectives are met for all assigned trials.
• Work collaboratively in a matrix organization with all internal stakeholders to deliver company clinical trial objectives on time, on budget and with high quality.
• Work with the CR&D Functional Area (FA) leads, as appropriate, in site management to accelerate enrollment and drive high quality.
• Take responsibility for any assigned clinical trial audits, working closely with the Clinical Quality Assurance group.
• Represent Clinical Study Management in operational excellence initiatives, in the systematic pursuit of optimal performance, efficiency, and quality across all aspects of clinical trial management and execution. Key components of operational excellence, in clinical study management, are: (1) quality and compliance, (2) process optimization, (3) technology integration, (4) risk management, (5) performance metrics, (6) cross-functional collaboration.
• Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve CR&D objectives.
• Responsible for ensuring appropriate scientific and operational training for staff members.
• Serve as a talent magnet and develop, coach, and retain top talent in the clinical program team.
• Sets clear performance standards and holds self and organization accountable for achieving results with flawless execution.
• Embrace metrics and performance standards (KPIs) to drive continuous improvement in execution.

Qualifications

• A post-graduate degree with 12+ years of relevant experience with a Bachelor’s degree or 10+ years of relevant experience with a Master's Degree with a demonstrated working experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry. 
• Significant experience managing international clinical studies and programs in oncology.
• Proven track record of contribution to and delivery of clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations.
• Significant management experience in a clinical trial setting with the ability to service and collaborate with different CR&D stakeholders in a matrix organization.
• Demonstrated situational leadership, independence, problem solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment.
• Significant management expertise should cover management of budget, resources, headcount, processes (and controls), productivity, quality and project delivery.
• A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.
• Strong communication skills requiring proficiency in written and spoken English.
• The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking and high emotional intelligence.
• Strong operational excellence mindset and experience.
• Strong leadership that will attract, motivate, inspire, develop and retain talented staff.
• In addition, leadership skills that enable and drive alignment with the goals, purpose and mission of our company.

The expected hourly range for this role is $108.65 to $118.75 depending on skills, competency, and the market demand for your expertise.

Position

The Clinical Program Manager, Oncology, Clinical Study Management, will plan and oversee the execution of clinical trials in oncology and other therapeutic areas, as needed. This role  works in close partnership with cross-functional teams to ensure studies are delivered on time and within budget, with a strong focus on quality,  operational excellence, and best-in-class clinical study management. The successful candidate will play a key role in driving study execution, managing risks, and enabling high-performance collaboration across functions and regions.

This role will require a minimum of 3 day a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices 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, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology or neuroscience.

What You’ll Do

• Develop and own the operational strategy, timelines, and operational plans for clinical trials, ensuring alignment with program objectives and overall business goals.
• Oversee and lead cross-functional clinical trial execution, leading proactive risk identification, assessment, management, and driving alignment on mitigation strategies.
• Ensure high standards of quality by overseeing that clinical studies are conducted in accordance with approved protocols, company SOPs, applicable regulations, and maintain ongoing inspection readiness across the program lifecycle.
• Serve as central point of contact to facilitate cross functional team effectiveness, drive operational efficiency, and provide clear direction and guidance to ensure successful study execution.
• Work with minimal oversight from the Clinical Study Management Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development, Finance, and Legal functions.
• Oversee and manage vendor relationships and performance to ensure that clinical studies are completed in accordance with contractual specifications for quality, timelines, and cost.
• Provide regular, clear updates on study progress, risks, and mitigation plans to stakeholders and executive management (e.g., Clinical Study Management, Project & Portfolio Management, Clinical Research).
• Ensure that all study-related documents are accurate, complete, and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems in a timely manner.
• Lead, manage, hire, develop, and mentor global and regional Clinical Study Management personnel.
• Contribute to improvement initiatives, operational excellence efforts, and cross-functional projects that add value to Eikon Therapeutics.

Qualifications

• Bachelor’s degree with 8 years, a Master’s degree with 6 years, or a PhD with 3 years of relevant experience in life sciences, healthcare, or related field preferred. 
• Fluency in English (strong reading, writing, and speaking skills with the ability to effectively communicate with colleagues and stakeholders at all levels) is required.
• In-depth knowledge of ICH-GCP, regulations, directives, and guidelines.
• Proficiency in clinical trial management systems (CTMS, RTSM (IRT), Veeva Vault suite) and electronic data capture (EDC) systems.
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
• Experience managing budgets, resources, processes and controls, productivity, quality, and project delivery.
• High sense of accountability and urgency to prioritize deliverables effectively.
• Growth mindset and ability to independently.
• PMP certification preferred.

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 $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise.

Position

We are seeking a skilled and highly motivated Associate Director, Biostatistics to join our talented team. The successful candidate will contribute their statistical expertise and strategic thinking to the design, execution, and analysis of clinical trials and experimental studies. In collaboration with cross-functional teams, you will lead statistical efforts that facilitate evidence-based conclusions and guide our research and development initiatives.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey 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

The ideal candidate for this role should possess a proven track record of designing and analyzing clinical trials and experimental studies, particularly within the biotechnology, pharmaceutical, or related industries. This candidate excels in leading interdisciplinary teams to design studies, developing statistical analysis plans, performing advanced statistical analyses, and providing guidance to team members. Their proficiency in statistical programming languages, understanding of regulatory guidelines, and excellent communication skills are essential for conveying complex statistical concepts to non-technical stakeholders. The ideal candidate also demonstrates leadership capabilities and a deep knowledge of emerging trends and best practices in biostatistics, statistical tools, and software.

What You’ll Do

• Collaborate with interdisciplinary teams to design clinical trials, experiments, and studies, ensuring appropriate statistical methodologies are employed.
• Lead the development of statistical analysis plans, including endpoints, sample size determination, randomization strategies, and statistical methodologies.
• Perform advanced statistical analyses on complex datasets, interpreting results and drawing actionable conclusions.
• Provide guidance and mentorship to biostatisticians and statistical programmers within the team.
• Contribute to regulatory submissions by providing statistical expertise and preparing relevant sections of documents.
• Stay current with emerging trends and best practices in biostatistics and their application in the biotechnology field.
• Drive the implementation and utilization of advanced statistical tools and software.

Qualifications

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years of clinical research and drug development experience.
• Proficiency in statistical programming languages (e.g., R, SAS) and experience with data visualization tools.
• Strong understanding of regulatory guidelines (ICH, FDA, etc.) and their implications on statistical analysis and reporting.
• Experience in authoring statistical analysis plans and performing statistical analyses and reporting using tables, listings, and figures. Oncology experience is a plus.
• Excellent communication skills with the ability to convey complex statistical concepts to non-technical stakeholders.
• Demonstrated leadership capabilities, including the ability to lead and mentor a team.
• Experience with Bayesian statistics and adaptive trial designs.
• Publications in peer-reviewed journals showcasing contributions to the field of biostatistics.

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 $200,000 to $218,500 depending on skills, competency, and the market demand for your expertise.

Position 

We are seeking a talented, experienced, and highly motivated Clinical Trial Manager (CTM) to join our oncology Clinical Operations team. This role will require onsite presence a minimum of 3 days a week in our Millbrae, CA or Jersey City, NJ office to ensure effective global clinical trial management. The candidate must have the ability to work independently, be an effective leader, and an engaged clinical study team member in a dynamic, fast-paced environment.  You will play a key role in contributing to high quality in-house clinical study management, ensuring compliance with regulatory guidelines, and contributing to planning, managing and the successful completion of global clinical studies. 

This position requires proficiency in Mandarin, Cantonese, Japanese, or Korean and English (strong reading, writing, and speaking skills and an ability to effectively communicate with colleagues and stakeholders at all levels). 

About You 

You have strong communication skills and are a collaborative, agile, detail oriented trial leader with global trial experience, and you have a passion for operational excellence and advancing patient care for grievous diseases. 

What You’ll Do 

• In partnership with Clinical Study Management, provide guidance and daily oversight for the successful in-house management of all aspects of international in-sourced clinical trials, delivering high quality study data, on time and on budget 
• Develop and execute operational plans for the successful in-house implementation and management of oncology clinical trials 
• Collaborate with cross-functional teams, including data management, clinical scientists, regulatory and investigators, to ensure operational excellence and rapid delivery of high quality data. Ability to examine functional issues from a broader organizational perspective. 
• Manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions (Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance), to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation 
• Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to efficiently and effectively deliver study site initiation, training, and monitoring activities to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines 
• Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to develop and maintain strong relationships with investigators, study coordinators, and study site personnel to facilitate patient recruitment and retention 
• Monitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelines 
• Ensure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle 
• As required, collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trial 
• Contribute to the development and review of study-related documents, such as protocols, informed consent forms, case report forms (CRFs), and standard operating procedures (SOPs) 
• Prepare study materials and establish procedures to ensure adherence to study protocols and administrative requirements 
• Lead the creation and maintenance of all study files, including the study master file, and oversight of site files  
• Lead periodic review of the Sponsor Trial Master File

Qualifications 

• PhD and 3 years of relevant experience, or Masters Degree and 6 years of relevant experience, or Bachelors Degree and 8 years of relevant experience  
• Proven experience in Clinical Operations; Oncology trial management experience preferred 
• In-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology research 
• Demonstrated experience in managing and executing clinical trials from start-up to closeout 
• Strong project management skills, with the ability to effectively prioritize tasks, allocate resources, and manage study timelines and budgets 
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with stakeholders at all levels, and create a clear sense of direction as necessary 
• Detail oriented with strong analytical and problem-solving abilities, capable of identifying and mitigating study risks and deviations 
• Proficiency in using Veeva clinical trial management systems (CTMS)  
• Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology
• 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 $130,000 to $142,500 depending on skills, competency, and the market demand for your expertise.

Position

The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices 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, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology.

What You’ll Do

• Team leader and builder, who manages clinical trial deliverables, timelines, and budgets per the Clinical Development and Operational Plans
• Works with minimal oversight from the Clinical Operations Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development functional teams
• Demonstrate broad understanding of therapeutic and clinical drug development expertise to influence study design and program-level decisions 
• Provide direction to cross-functional study teams to ensure successful study execution Ensure that clinical studies are conducted  following approved protocols, FDA Regulations, ICH-GCP, EMA, PMDA, other relevant regulations, directives, and guidelines, and company procedures and quality documents
• Oversee risk identification, assessment, and mitigation strategies to ensure patient safety and data integrity
• Responsible for the implementation of processes and systems that will facilitate inspection readiness throughout the lifecycle of the trial.
• Oversee the preparation and maintenance of detailed clinical trial project timelines
• Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed following contract specifications of time, cost and quality.
• Work with finance, legal, and external vendors to ensure the assigned studies are meeting the target milestones
• Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research)
• Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems.
• Responsible for hiring, performance management, career development, and providing mentorship to Clinical Study Management personnel.
• Contribute to initiatives and projects adding value to Eikon Therapeutics

Qualifications

• Minimum of 10 years of related experience with a Bachelor’s degree or 8 years and a post-graduate degree.
• Experience leading large, global clinical trials, preferably in oncology
• In-depth knowledge of ICH-GCP, EMA guidelines and other relevant regulations and guidelines.
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
• Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.
• High sense of accountability and urgency to prioritize deliverables.
• Growth mindset and capable of working independently.

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 $183,000 to $199,500 depending on skills, competency, and the market demand for your expertise.

Position

As a Clinical Trial Management Associate (CTMA), you will serve as a critical inhouse clinical operations partner in the execution, and oversight of Phase I–III global oncology clinical trials. Positioned between the Clinical Trial Associate (CTA) and Clinical Trial Manager (CTM), the CTMA brings increased ownership, autonomy, and judgment to the execution of clinical studies. You will independently manage assigned study responsibilities and help ensure the delivery of high-quality, compliant, and timely trial data in support of our mission to bring transformative therapies to patients.

This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices.

This position requires fluency in one of the following languages due to the nature of site interactions in various regions in EMEA or LATAM: Portuguese, German, Italian, French, Polish. 

About You

You bring a strong operational mindset, an ability to work independently, and a flexible and collaborative spirit. You are looking to grow beyond a CTA role and take on more direct responsibility for study deliverables, bringing with you valuable clinical research experience and a strong passion to contribute meaningfully to drug development through consistent operational excellence.

What You’ll Do

• Proactively support Clinical Study Management team members in the day-to-day execution of global clinical trials, with increasing independence and accountability for specific study components. Collaborate closely with assigned global (gCSM)/regional Clinical Study Management (rCSM) teams, ensuring operational excellence throughout study execution.
• Manage and coordinate critical study activities with minimal oversight such as site communications, and maintenance of study timelines, risk logs, and action trackers.
• Lead the coordination and execution of site start-up assigned activities across multiple countries, working closely with regulatory, study start-up, and site engagement and monitoring excellence inhouse teams.
• Independently maintain and oversee trial master file (TMF) quality and completeness, in collaboration with TMF Operations, ensuring inspection readiness at all times.
• Draft, review, and manage study documents such as monitoring plans, training materials, and site communications under the guidance of the CTM.
• Track and reconcile investigational product (IP) and clinical supply/lab shipments, proactively flagging discrepancies and collaborating with supply chain to resolve issues.
• Support site level budget tracking invoice reconciliation, and vendor communications in partnership with Clinical Operations and Finance.
• Coordinate and contribute to key study meetings (e.g., team meetings, vendor meetings, investigator meetings), including agenda development, meeting facilitation, and action item follow-up.
• Monitor enrollment and site performance metrics, contributing to analysis and mitigation strategies to meet enrollment goals and drive operational excellence.
• Partner with data manager lead to ensure timely site follow up (assigned sites) for query reconciliation to meet the study milestones (e.g., interim analyses goals, etc.).
• Ensure compliance with study protocols, SOPs, and regulatory guidelines (e.g., ICH-GCP, FDA) across all operational activities.

Qualifications

• Bachelor’s degree with 3+ years of relevant clinical trial experience or a Master’s degree with 1–2 years of experience.
• Demonstrated ability to work independently and manage multiple competing priorities with minimal oversight.
• Strong understanding of clinical trial processes and regulatory requirements (ICH-GCP, FDA).
• Experience using clinical systems such as CTMS, EDC, and eTMF; Veeva Vault experience is a plus.
• Excellent organizational and time management skills with high attention to detail.
• Strong written and verbal communication skills and ability to interact confidently with internal stakeholders and external partners.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project).
• Previous oncology trial experience preferred but not required.
• Working experience in LATAM/EMEA

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 $133,000 depending on skills, competency, and the market demand for your expertise.

Position 

We are seeking a highly experienced, collaborative, and detail-oriented Contract Senior Manager capable of helping Eikon optimize its clinical Site Engagement and Monitoring function to support delivery of world class clinical drug development. The successful candidate will work closely with the Eikon Site Engagement and Monitoring Excellence (SEME) team, global Clinical Research Associates (CRAs) and internal study teams across therapeutic areas to oversee clinical site engagement and monitoring activities.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices 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 have significant monitoring experience and a passion for leading, training, and mentoring CRAs. You are adept at developing and maintaining relationships with clinical trial sites and demonstrate the ability to oversee monitoring with a strong knowledge of Good Clinical Practice and clinical trial regulations to ensure subject safety, data integrity and inspection readiness. You have experience developing systems, resources, and tools to support high-quality monitoring and forecast CRA resourcing. You also have experience utilizing a Functional Service Provider (FSP) monitoring model embedded within a sponsor study team to execute major data collection and study milestones. You are a strong collaborator across clinical functional areas with a demonstrated ability to creatively and independently resolve complex issues that impact sites and CRAs.

What You’ll Do 

• Establish and foster effective relationships with internal and external stakeholders, such as the CRO and study team members.
• Promote awareness of Eikon’s clinical pipeline and programs to trial sites, investigators, and networks.
• Complete or oversee the qualification of sites and promptly facilitate site selection to support study milestone goals.
• Develop and maintain strong site relationships to support the site/patient experience and drive study team goals such as enrollment and major study milestones.
• Onboard and train CRAs to conduct high quality site qualification, initiation, and monitoring visits.
• Review and approve monitoring trip reports in the Clinical Trial Management System (CTMS).
• Perform and document monitoring oversight activities to assess monitoring quality and CRA performance.
• At times, perform the CRA role as needed, to support prompt site qualification, initiation, monitoring and close-out visits at key sites to meet urgent study milestones.
• Regularly review site and monitoring Key Risk Indicator (KRI) metrics to detect issues and ensure prompt resolution.
• Serve as an escalation point for CRAs and as a Subject Matter Expert (SME) to resolve site management and monitoring quality issues and develop/ensure implementation of Corrective and Preventive Action (CAPA) Plans as needed.
• Support CRAs to ensure sites are inspection-ready and support Eikon Clinical Quality Assurance during site inspections.
• Effectively utilize the CTMS and Trial Master File (TMF) to ensure SEME documents are promptly filed and site data is accurate.
• Contribute to monitoring process improvement initiatives by developing functional area Standard Operating Procedures (SOPs), Work Instructions (WIs), job aids, and tools.
• Contribute to improving site selection, monitoring, and monitoring oversight trip report templates in Veeva CTMS by identifying gaps, suggesting updates, testing and implementing change controls.

Qualifications

• 8+ years of experience with a Bachelor's degree, or 6+ years with a post graduate degree
• Experience utilizing Veeva CTMS and TMF is required.
• Experience supporting site and/or sponsor inspections is required.
• Working on-site from an Eikon office location (Jersey City, NJ or Millbrae, CA) 3 days per week is required during non-travel weeks.​

The expected hourly range for this role is $77.40 to $84.50 depending on skills, competency, and the market demand for your expertise.

Position

We are seeking a skilled and highly motivated Associate Director, Biostatistics to join our talented team. The successful candidate will contribute their statistical expertise and strategic thinking to the design, execution, and analysis of clinical trials and experimental studies. In collaboration with cross-functional teams, you will lead statistical efforts that facilitate evidence-based conclusions and guide our research and development initiatives.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey 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

The ideal candidate for this role should possess a proven track record of designing and analyzing clinical trials and experimental studies, particularly within the biotechnology, pharmaceutical, or related industries. This candidate excels in leading interdisciplinary teams to design studies, developing statistical analysis plans, performing advanced statistical analyses, and providing guidance to team members. Their proficiency in statistical programming languages, understanding of regulatory guidelines, and excellent communication skills are essential for conveying complex statistical concepts to non-technical stakeholders. The ideal candidate also demonstrates leadership capabilities and a deep knowledge of emerging trends and best practices in biostatistics, statistical tools, and software.

What You’ll Do

• Collaborate with interdisciplinary teams to design clinical trials, experiments, and studies, ensuring appropriate statistical methodologies are employed.
• Lead the development of statistical analysis plans, including endpoints, sample size determination, randomization strategies, and statistical methodologies.
• Perform advanced statistical analyses on complex datasets, interpreting results and drawing actionable conclusions.
• Provide guidance and mentorship to biostatisticians and statistical programmers within the team.
• Contribute to regulatory submissions by providing statistical expertise and preparing relevant sections of documents.
• Stay current with emerging trends and best practices in biostatistics and their application in the biotechnology field.
• Drive the implementation and utilization of advanced statistical tools and software.

Qualifications

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years of clinical research and drug development experience.
• Proficiency in statistical programming languages (e.g., R, SAS) and experience with data visualization tools.
• Strong understanding of regulatory guidelines (ICH, FDA, etc.) and their implications on statistical analysis and reporting.
• Experience in authoring statistical analysis plans and performing statistical analyses and reporting using tables, listings, and figures. Oncology experience is a plus.
• Excellent communication skills with the ability to convey complex statistical concepts to non-technical stakeholders.
• Demonstrated leadership capabilities, including the ability to lead and mentor a team.
• Experience with Bayesian statistics and adaptive trial designs.
• Publications in peer-reviewed journals showcasing contributions to the field of biostatistics.

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 $200,000 to $218,500 depending on skills, competency, and the market demand for your expertise.