Eikon Therapeutics, Inc.
Clinical Trial Manager, Oncology
Eikon Therapeutics, Inc., Millbrae, California, United States, 94031
Overview
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. Eikons discovery platform enables real-time, molecular-resolution measurements of protein movement in living cells, unlocking otherwise intractable classes of proteins as drug targets. Position
Clinical Trial Manager (CTM)
to join the oncology Clinical Operations team. The candidate must be able to work independently, be an effective leader, and be an engaged clinical study team member in a dynamic, fast-paced environment. You will contribute to high quality in-house clinical study management, ensure regulatory compliance, and help plan, manage, and complete global clinical studies. This role will require a minimum of 3 days a week 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 expected team growth and collaboration. 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 Youll Do
In partnership with Clinical Study Management, provide guidance and daily oversight for the successful in-house management of all aspects of international 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 to deliver efficient site selection, feasibility assessments, and preparation of study-related documentation. Collaborate with other Clinical Operations functions to 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 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 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. Collaborate with external vendors (CROs, central laboratories, and imaging providers) to ensure their efficient and effective deliverables to the trial as required. Contribute to the development and review of study-related documents, such as protocols, informed consent forms, CRFs, and 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 with 3 years of experience; or a Masters Degree with 6 years of relevant experience; or a Bachelors degree with 8 years of relevant experience in a life sciences, healthcare, or related field. In-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology research. Experience in managing and executing clinical trials from start-up to closeout. Strong project management skills with the ability to prioritize tasks, allocate resources, and manage study timelines and budgets. Excellent interpersonal and communication skills to collaborate with stakeholders at all levels and provide clear direction as needed. Detail-oriented with strong analytical and problem-solving abilities to identify and mitigate study risks and deviations. Proficiency with Veeva CTMS (clinical trial management systems). Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology. Compensation and Benefits
The expected salary range for this role is $130,000 to $142,500 depending on skills, competency, and market demand. Employee compensation includes bonus and equity, in addition to generous benefit programs: 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 life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site 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. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes. #J-18808-Ljbffr
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. Eikons discovery platform enables real-time, molecular-resolution measurements of protein movement in living cells, unlocking otherwise intractable classes of proteins as drug targets. Position
Clinical Trial Manager (CTM)
to join the oncology Clinical Operations team. The candidate must be able to work independently, be an effective leader, and be an engaged clinical study team member in a dynamic, fast-paced environment. You will contribute to high quality in-house clinical study management, ensure regulatory compliance, and help plan, manage, and complete global clinical studies. This role will require a minimum of 3 days a week 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 expected team growth and collaboration. 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 Youll Do
In partnership with Clinical Study Management, provide guidance and daily oversight for the successful in-house management of all aspects of international 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 to deliver efficient site selection, feasibility assessments, and preparation of study-related documentation. Collaborate with other Clinical Operations functions to 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 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 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. Collaborate with external vendors (CROs, central laboratories, and imaging providers) to ensure their efficient and effective deliverables to the trial as required. Contribute to the development and review of study-related documents, such as protocols, informed consent forms, CRFs, and 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 with 3 years of experience; or a Masters Degree with 6 years of relevant experience; or a Bachelors degree with 8 years of relevant experience in a life sciences, healthcare, or related field. In-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology research. Experience in managing and executing clinical trials from start-up to closeout. Strong project management skills with the ability to prioritize tasks, allocate resources, and manage study timelines and budgets. Excellent interpersonal and communication skills to collaborate with stakeholders at all levels and provide clear direction as needed. Detail-oriented with strong analytical and problem-solving abilities to identify and mitigate study risks and deviations. Proficiency with Veeva CTMS (clinical trial management systems). Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology. Compensation and Benefits
The expected salary range for this role is $130,000 to $142,500 depending on skills, competency, and market demand. Employee compensation includes bonus and equity, in addition to generous benefit programs: 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 life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site 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. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes. #J-18808-Ljbffr