Qureos Mentor

Eikon Therapeutics

<div><div>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.</div>
Position

Eikon Therapeutics is seeking a highly motivated Technician 1, Lab Support to support our dynamic R&amp;D teams. This individual will contribute to efficient laboratory operations by performing a variety of core lab support duties.

About You
The ideal applicant is organized, able to multi-task across multiple responsibilities, and comfortable working in a fast-paced environment. This role reports to the Lab Manager and involves daily interaction with scientific staff. This is a full-time, non-exempt position working 40 hours per week, Monday&ndash;Friday.

What You'll Do
<ul>
<li>Transport, clean, and sterilize glassware, plasticware, and laboratory equipment by safely operating an autoclave, commercial dishwasher, and hand-washing delicate items.</li>
<li>Handle biohazardous and chemical waste in accordance with OSHA and institutional safety standards.</li>
<li>Maintain laboratory spaces, including cleaning biosafety cabinets, incubators, and performing general housekeeping tasks.</li>
<li>Prepare, restock, and maintain various culture media, buffers, and stock solutions.</li>
<li>Perform general laboratory maintenance, including equipment sterilization, supply restocking, and inventory recordkeeping.</li>
<li>Replace LN&#8322;, CO&#8322;, and other laboratory gases as required.</li>
<li>Monitor controlled-temperature units and perform routine maintenance such as defrosting freezers, organizing freezer space, recording issues, and documenting temperature monitoring logs.</li>
<li>Collaborate with team members to maintain a clean, organized, and efficient laboratory environment.</li>
<li>Coordinate with external vendors for maintenance, repair, and calibration of laboratory instruments and equipment.</li>
<li>Participate in an on-call rotation with other team members.</li>
<li>Ensure compliance with all safety protocols, including proper hazardous waste disposal and adherence to laboratory hygiene standards.</li>
<li>Provide routine laboratory operational support as needed.</li>
</ul>
Qualifications
<ul>
<li>1-2 years of related experience in a laboratory setting.</li>
<li>Bachelor's degree (B.S.) in Life Sciences or a related field preferred.</li>
<li>Ability to work independently in a fast-paced environment and manage multiple tasks simultaneously.</li>
<li>Knowledge of laboratory sanitation, sterilization methods, and related equipment; experience with autoclaves and commercial dishwashers preferred.</li>
<li>Strong attention to detail, excellent organizational skills, and the ability to follow protocols and SOPs.</li>
<li>Customer-service&ndash;oriented team player with strong interpersonal and communication skills.</li>
<li>Ability to lift or handle 50 lbs. and move heavy Dewars safely.</li>
<li>Proficiency with Microsoft Office, Excel, and basic computer applications.</li>
</ul>
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
<ul><li>401k plan with company matching
</li><li>Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
</li><li>Mental health and wellness benefits
</li><li>Weeklong summer and winter holiday shutdowns
</li><li>Generous paid time off and holiday policies
</li><li>Life/AD&amp;D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&amp;D policies
</li><li>Enhanced parental leave benefit
</li><li>Daily subsidized lunch program when on-site
</li></ul>The expected hourly range for this role is $25.00/hr to $27.41/hr depending on skills, competency, and the market demand for your expertise.<div>
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

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.</div></div>

Technician 1, Lab Support

<div><div>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.</div>
Position

The Senior Manager, Statistical Programming will be responsible for statistical programming deliverables in Eikon clinical studies. In this role, you will report to the Sr. Director, Statistical Programming.
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 &amp; collaboration.

About You

You have experience with the oversight and management of statistical programming deliverables for clinical studies, ensuring that they meet quality, compliance, and timeliness requirements. You are excited to collaborate with various stakeholders including Biostatistics, Clinical Research, Regulatory, Clinical Safety, Data Management, and PK/PD Modeling.

What You'll Do
<ul>
<li>Be responsible for statistical programming deliverables in multi-disciplinary interactions.</li>
<li>Provide development, review, and approval for statistical programming documents and oversee vendor programming work to ensure high quality as well as operational excellence.</li>
<li>Have in-depth understanding of CDISC standards (SDTM, ADaM, Define.xml, etc.) and apply corresponding knowledge to develop ADaM specifications, SAS programs, and review regulatory electronic submission packages.</li>
<li>Conduct statistical programming and/or statistical simulations to support clinical decision making, regulatory interaction, and publications.</li>
<li>Support statistical programming quality control process and develop functional Standard Operating Procedures (SOPs) and Work Instructions.</li>
<li>Support the development of CRFs, edit checks, review of Data Transfer Specifications, and any other collaborations with Data Management function.</li>
</ul>
Qualifications
<ul>
<li>Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant field (e.g., statistics, biostatistics, computer science, or a related discipline).</li>
<li>Proven expertise in SAS and clinical trial programming required; experience in R or Python is a plus.</li>
<li>Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards based on quality, compliance, and timeliness requirements.</li>
<li>US or worldwide drug regulatory application submission experience including the development of electronic submission deliverables.</li>
<li>Experience with CDISC and ADaM standards.</li>
<li>Demonstrated success in the assurance of deliverable quality and process compliance.</li>
<li>Excellent interpersonal skills and ability to negotiate and collaborate effectively.</li>
<li>Recent experience working in the field of oncology preferred.</li>
<li>Experience developing and implementing statistical programming standards preferred.</li>
<li>Experience developing JReview reports to support medical monitoring preferred.</li>
<li>Experience developing AI application or automation system to improve programming efficiency preferred.</li>
<li>Strong working knowledge of reporting processes (e.g., SOPs) and statistical computing environments preferred but not required</li>
</ul>
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
<ul><li>401k plan with company matching
</li><li>Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
</li><li>Mental health and wellness benefits
</li><li>Weeklong summer and winter holiday shutdowns
</li><li>Generous paid time off and holiday policies
</li><li>Life/AD&amp;D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&amp;D policies
</li><li>Enhanced parental leave benefit
</li><li>Daily subsidized lunch program when on-site
</li></ul>The expected salary range for this role is $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise.<div>
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

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.</div></div>

Senior Manager, Statistical Programming

<div><div>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.</div>
Position

We are seeking a seasoned 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 as a Senior Director, Clinical Research, Oncology. In this role, you will play a pivotal part in advancing our Oncology pipeline by providing medical expertise, strategic leadership, and operational oversight for multiple clinical development studies.

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 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 &amp; collaboration.

What You'll Do
<ul>
<li>Design and conduct early-stage or late-stage clinical development trials, including, but not limited to: assessing clinical safety and efficacy data, performing medical monitoring, and be responsible for other study-related clinical activities.</li>
<li>Work closely with biomarker, discovery, and translational research scientists.</li>
<li>Interpret reports, prepare oral and written results of product research, and participate in the discussion of strategies formulated within the disease areas that Eikon is focusing on.</li>
<li>Collaborate closely with Clinical Science and other relevant functions within Eikon and potential partners including discovery, translational, and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, regulatory representatives, as well as personnel from Global Clinical Operations, and other support functions.</li>
<li>Establish strong working relationships and collaborations with external study investigators, key opinion leaders in drug development, and external alliance partners.</li>
<li>Work closely with functional partners (Data Management, Clinical Operations, Biostatistics, Regulatory) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in clinical development in close collaboration with key functional stakeholders.</li>
<li>Work in partnership with colleague study responsible physicians and clinical scientists to ensure development of high-quality study protocols including use of consistent processes/standards across studies.</li>
<li>Work closely with functional partners to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.</li>
</ul>
Qualifications
<ul>
<li>MD or DO degree with significant experience in Oncology.</li>
<li>Minimum of 5-7 years of clinical experience, including 3+ years in drug development.</li>
<li>Significant experience in clinical practice with direct patient care (preferably in Oncology)</li>
<li>Proven track record in leading clinical trials, including medical monitoring of early and late clinical trials and managing complex projects.</li>
<li>In-depth knowledge of clinical research methodologies, GCP, and regulatory requirements.</li>
<li>Ability to work effectively in a matrixed environment.</li>
<li>Strong analytical, organizational, and problem-solving skills.</li>
<li>Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.</li>
<li>Passion for innovation and improving patient outcomes.</li>
<li>Experience with IND and/or NDA filings is preferred.</li>
</ul>
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
<ul><li>401k plan with company matching
</li><li>Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
</li><li>Mental health and wellness benefits
</li><li>Weeklong summer and winter holiday shutdowns
</li><li>Generous paid time off and holiday policies
</li><li>Life/AD&amp;D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&amp;D policies
</li><li>Enhanced parental leave benefit
</li><li>Daily subsidized lunch program when on-site
</li></ul>The expected salary range for this role is $270,000 to $294,500 depending on skills, competency, and the market demand for your expertise.<div>
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

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.</div></div>

Senior Director, Clinical Research - Oncology

<div><div>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.</div>
Position

The Director Study Site Engagement &amp; Monitoring Excellence will be responsible for leading the development and execution of Eikon's global trial site engagement strategy, including oversight and accountability for all internal/external managed site monitoring activities to ensure predictable delivery of high-quality data and establish Eikon as a preferred sponsor for clinical sites.

The Director will ensure effective collaboration with clinical study teams, and Functional Service Provider (FSP) partners, to implement excellent site relationship management and site monitoring activities to accelerate operational excellent delivery of Eikon's clinical programs.

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 &amp; collaboration.

What You'll Do

Strategic Leadership
<ul>
<li>Define and implement site engagement strategies to improve relationships</li>
<li>Support the build of new partnerships and networks</li>
<li>Support high quality monitoring approaches and ensure alignment with regulatory standards</li>
<li>Serve as liaison between clinical study teams and investigative sites</li>
</ul>
Operational Support
<ul>
<li>Provide guidance, oversight and training to the study site engagement team, including CRA site monitors, whether insourced or outsourced suppliers, to maximize effectiveness and acceleration in Eikon's operational execution of clinical research.</li>
<li>Develop and maintain appropriate performance standards, processes and documentation for harmonized site engagement and monitoring support across Eikon's clinical programs.</li>
<li>Maintain regular information exchange within the study site engagement team, identify common elements of study support across regions/countries to codify and apply lessons learned, troubleshoot issues and distribute acquired site intelligence to Clinical Operations study teams and Clinical Development stakeholders as required.</li>
<li>Oversee resource and talent management of site engagement team, including CRA monitors, whether insourced or via outsourced suppliers, across relevant regional/country clusters to maintain quality of monitoring that deliver and achieve Clinical Operations study team goals.</li>
<li>Accountable for overall oversight and training of FSP, study site engagement and CRAs by country/region, including identifying and managing CRA performance issues. Responsible for ensuring associated corrective and preventative actions are put in place, and that ICH GCP compliance, regulatory, quality and timeline objectives are met for all trials executed globally.</li>
<li>Responsible for site and monitoring quality using interpretive signals in conjunction with local country intelligence to proactively identify risks. Lead risk assessment at the site/country level for designated studies, including identification of mitigation and control. Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.) and demonstrate use of data to enhance quality and accelerate study delivery. Track site engagement metrics and satisfaction scores.</li>
<li>Demonstrate a learning culture by ensuring site quality and trends, including preventative actions are shared across study &amp; assets in the clinical programs to drive accelerated drug delivery.</li>
<li>Be the point of escalation for issues that arise in site engagement, escalating as necessary and keeping the relevant Clinical Operations study team informed of escalation and resolution. Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions and timelines.</li>
<li>Manage functional budget, including resource projections, capacity assessment and vendor (e.g., FSP) oversight and evaluation, to ensure adequate and appropriate resourcing for Eikon's clinical trial portfolio.</li>
</ul>
Cross Functional Collaboration
<ul>
<li>Align with global Clinical Development stakeholders to ensure strategy and approach for clinical programs and studies is appropriate to meet study goals while incorporating study engagement team, including CRA monitors.</li>
<li>Contribute to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes and clinical system capabilities to consistently deliver operational excellence.</li>
<li>Collaborate with Clinical Development leadership to partner on important projects and stay current with relevant industry trends and innovations to ensure best practices in study site engagement are applied across Eikon.</li>
<li>Serve as a talent magnet and develop, coach, and retain top talent in the team. Set clear performance standards and holds self and organization accountable for achieving results. Embraces metrics and performance standards (KPIs).</li>
</ul>
Qualifications
<ul>
<li>Post Graduate degree with 10+ years of experience or a Bachelor's degree with 12+ years of experience in a relevant field, such as Life Sciences, Nursing, or a related discipline.</li>
<li>Significant management experience in oncology clinical trial setting with the ability to effectively collaborate with different Clinical R&amp;D stakeholders in a matrix organization. Management expertise should cover management of budget, resources, headcount, processes (and controls), productivity, quality and project delivery.</li>
<li>A complete understanding of ICH GCP and global/regional regulatory requirements is required.</li>
<li>Strong communication skills requiring proficiency in written and spoken English. The incumbent must be competent and effective in written and verbal communication. Skills in more than one language are an advantage in this role.</li>
<li>Strategic thinking and high emotional intelligence.</li>
<li>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.</li>
<li>Travel: up to 25% travel expected</li>
</ul>
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
<ul><li>401k plan with company matching
</li><li>Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
</li><li>Mental health and wellness benefits
</li><li>Weeklong summer and winter holiday shutdowns
</li><li>Generous paid time off and holiday policies
</li><li>Life/AD&amp;D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&amp;D policies
</li><li>Enhanced parental leave benefit
</li><li>Daily subsidized lunch program when on-site
</li></ul>The expected salary range for this role is $204,000 to $223,250 depending on skills, competency, and the market demand for your expertise.<div>
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

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.</div></div>

Director, Site Engagement & Monitoring Excellence

Join Eikon Therapeutics and explore 4   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Eikon Therapeutics

ABOUT_COMPANY

Technician 1, Lab Support

Senior Manager, Statistical Programming

Senior Director, Clinical Research - Oncology

Director, Site Engagement & Monitoring Excellence