Director, Trial Master File Operations
Eikon Therapeutics, Inc. Job In Millbrae, CA
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
As the Director, Trial Master File Operations, you will be responsible for leading the TMF (Trial Master File) operations function for clinical trials across Eikon Therapeutics. This is a senior-level position that requires a strategic thinker with the ability to drive change and improve processes. The successful candidate will be a strong leader with excellent communication and collaboration skills, and experience in managing TMFs for clinical trials. You will be accountable for ensuring the completeness, accuracy, and regulatory compliance of TMFs, and overseeing all TMF-related activities across the clinical trial portfolio.
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), New York City (NYC) or Millbrae (CA) 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 a strategic and collaborative leader that drives transformative initiatives to create efficient processes that meet rigorous quality standards. You are an effective change manager with the ability to be hands on to achieve organizational objectives in support of the business and TMF needs across the entire Clinical Research & Development organization. You have exceptional proficiency in utilizing data to drive decision-making and performance improvements.
What You'll Do
* Lead the TMF Operations function to support Clinical Research and Development
* Manage and oversee the TMF Operations team, including hiring, training, and performance management
* Manage, provide direction, and maintain strong relationships with TMF third party vendors, including driving resolution of issues and remediation activities
* Oversee on-site TMF facilities and off-site records storage facilities, including ensuring compliant chain-of-custody procedures
* Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices
* Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements
* Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle
* Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival
* Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, CRO, and other stakeholders
* Monitor and report TMF metrics to senior management, identifying areas for process improvement and implementing changes as needed
* Monitor and report on TMF completeness and readiness to Clinical Trial Teams, including study specific TMF review activities
* Serve as functional TMF inspection lead for regulatory inspections, providing relevant documents and information as required
* Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required
* Keep informed of regulatory changes and industry best practices related to TMF operations and coordinate with stakeholders to implement continuous operational excellence
* Serve as eTMF platform business owner, including managing eTMF system configuration changes in accordance with established change control processes and monitoring the impact of configuration changes to optimize performance
* Serve as sponsor archivist providing oversight of the contents and access to the archive
Qualifications
* Minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
* Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations
* Experience with electronic Trial Master File systems (e.g., Veeva) and related technology platforms
* Proficient knowledge of DIA TMF Reference Model
* Knowledge of clinical trial operations and processes, preferred
* Demonstrated leadership skills to drive results to achieve optimal outcomes
* Experience in managing a team and providing leadership to drive performance
* Excellent communication skills and ability to collaborate with cross-functional teams
* Ability to manage multiple projects simultaneously and meet tight deadlines
* 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 $200,000 to $218,500 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.
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.
Senior Director, Clinical Finance
Eikon Therapeutics, Inc. Job In Millbrae, CA
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
Eikon Therapeutics is seeking an accomplished Senior Director, Clinical Finance to lead financial strategy and operations for our clinical programs. In this critical leadership role, you will oversee financial planning & analysis (FP&A), accounting, and payments related to clinical trials, ensuring financial discipline and operational efficiency. Reporting to the Executive Director, Finance, you will work cross-functionally with clinical operations, R&D, and executive leadership to drive financial insights that support data-driven decision-making.
About You
You are a strategic and detail-oriented finance leader with deep expertise in clinical finance within the biopharmaceutical, pharmaceutical, or healthcare industries. You excel at navigating complex financial landscapes, translating data into actionable insights, and optimizing processes to support business growth. You thrive in fast-paced, high-growth environments and are a collaborative partner who fosters strong relationships across teams.
Key Responsibilities
* Develop and execute financial strategies that align with Eikon's clinical program objectives.
* Lead clinical financial planning processes, including annual budgeting, monthly forecasting, and long-term financial modeling.
* Oversee clinical trial financial operations, including trial budgeting, site payments, and vendor financial management.
* Manage financial oversight of multiple global clinical trials, ensuring efficiency, compliance, and cost-effectiveness.
* Create and maintain robust financial models to support accurate forecasting and scenario analysis.
* Provide strategic financial insights to senior leadership, influencing key business decisions.
* Ensure compliance with internal controls, financial reporting standards, and regulatory guidelines.
* Identify and implement process improvements to enhance financial operations and reporting accuracy.
* Support strategic initiatives such as mergers & acquisitions, partnerships, and licensing deals.
* Lead, mentor, and develop a high-performing finance team, fostering a culture of excellence and continuous improvement.
Qualifications & Experience
* 15+ years of experience with Bachelor's degree or 12+ years with a post graduate degree in financial planning & analysis, with a strong focus on clinical finance in the biopharma or healthcare sector.
* Bachelor's degree in finance, accounting, or a related field; MBA or CPA preferred but not required.
* Deep understanding of clinical trial operations, budgeting, and financial oversight of CROs (Clinical Research Organizations).
* Proven ability to collaborate with R&D and non-finance teams while maintaining financial integrity.
* Expertise in financial modeling, forecasting, budgeting, and long-term planning.
* Strong communication skills, with the ability to distill complex financial insights into actionable recommendations for senior executives.
* Experience leading and developing finance teams in high-growth environments.
* Knowledge of financial reporting requirements for publicly traded companies.
* Proficiency with ERP systems and financial reporting tools.
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 $235,000 to $256,500 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.
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.
Postdoctoral Scientist - Urbanowicz Lab - Computational Biomedicine
San Diego, CA Job
Principal Investigator, Dr. Ryan Urbanowicz, is seeking a Postdoctoral Scientist to join the Department of Computational Biomedicine!
The primary focus of the URBS Lab (Unbounded Research in Biomedical Systems) is the development, evaluation and application of machine-learning (ML) and artificial intelligence (AI) tools/methods targeting various biomedical data types and problems. We develop and apply methods that (1) automate and provide rigor to machine-learning analyses, (2) can detect complex patterns of association, (e.g., epistasis and heterogeneity), (3) are interpretable/explainable to promote trust and translational adoption, as well as to identify and address sources of bias, (4) scale to “big data” and (5) flexibly adapt to common data challenges, (i.e., missing values, class imbalance, consideration of covariates). We aim to make ML and AI tools that are applicable to a wide variety of biomedical problems and that are accessible, reliable, reproducible, flexible, user-friendly, computationally efficient and transparent. Our lab holds particular interest in the research of rule-based ML, automated ML, feature selection and evolutionary algorithms. To learn more, please visit: Cedars-Sinai | Urbanowicz Lab
Are you ready to be a part of breakthrough research?
The URBS-lab focuses on the development and application of machine learning, artificial intelligence, and statistical methodologies targeting a variety of domains and data types within biomedical research. Emphasis is placed on developing methods that are interpretable/explainable, scalable to ‘big data', and capable of detecting complex patterns of association. Current research focuses on automated machine learning, rule-based modeling, feature selection, and evolutionary optimization. Other areas of interest include (but are not limited to) rare-variant analysis, data simulation, data integration, heterogeneous patient subgroup identification, time-series analysis, deep learning, and identifying and correcting for biases. We are a highly collaborative lab with access to EHR, genomic, and other ‘omics' data in areas of research such as obstructive sleep apnea, congenital heart disease, pancreatic cancer, transplantation donor-recipient matching, and hospital readmission.
Working independently but in close cooperation and in consultation with Dr. Ryan Urbanowicz and other research scientists, the Postdoctoral Scientist will perform routine and complex computational, mathematical, and statistical procedures throughout the training period. As a Postdoctoral Scientist you may develop, adapt, and implement new techniques, algorithms, analysis pipelines, and software, as well as analyze, interpret, summarize, and compile data.
Primary Duties and Responsibilities:
May assist in the preparation of grant proposals, but is not responsible for generating grant funds.
May participate in publications and presentations as author or co-author.
Designs and performs experiments. Will keep appropriate experimental records and documentation and analyze the results with the Principal Investigator.
Analyzes interpret, summarizes, and compiles data.
Operates and maintains equipment and instruments.
May observe MD-patient or MD-human research subject interactions as it pertains directly to research being performed.
Qualifications
Education:
Doctorate (MD, PhD, VMD, or DDS) in computer science, computational biology, data science, bioinformatics, biomedical informatics, biostatistics, engineering, or a related quantitative field is required.
Experience and Skills:
Competitive candidates will be proficient in scientific writing having published in more than one of the areas mentioned as well as experience with algorithm development/application.
Including a cover letter and publication examples (first authorship) are preferred, but not required.
Independently works on research projects designed in collaboration with one or more mentors within an area of specialization.
Acquires thorough technical and theoretical knowledge of research projects and objectives during one to five (1-5) year post-doctoral appointment.
Demonstrated aptitude to perform experimental protocols and procedures, including detailed data collection.
Knowledge of safety standards and maintenance of specialized equipment.
About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Req ID : 8644
Working Title : Postdoctoral Scientist - Urbanowicz Lab - Computational Biomedicine
Department : Computational Biomedicine
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Postdoctoral Scholar
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $62,400 - $93,600
Clinical Research Specialist II - Clinical Coordinating Center (CCC)
Los Angeles, CA Job
This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time.
Within ACRO, the Clinical Coordinating Center (CCC) offers infrastructure and expertise for investigator-initiated trials (IITs) and collaborative, multi-site clinical research. The CCC Clinical Research Specialist II will serve in a cross-functional role and interface with internal and external stakeholders to coordinate all aspects of assigned investigator-initiated and multi-site projects.
The Clinical Research Specialist II provides clinical research expertise by participating in the design and implementation of research projects as needed. Responsible for specific and assigned aspects of research infrastructure development, coordinates projects, and communicates status and improvement areas to leadership. May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities
Provides research writing activities such as developing scientific documents for abstracts, publications, presentations, funding applications, and study protocols.
Serves as an internal advisor for specific departmental activities.
Provides guidance regarding project planning, project logistics, and project implementation.
Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.
Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
Coordinates research projects at an institutional or departmental level.
Communicates project status and improvement areas with leadership in a timely manner.
Projects may include, but are not limited to investigator-initiated protocol development including protocol writing, case report form development, budget development, and coordination of departmental research committees.
May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Qualifications
This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time.
Requirements:
Bachelor's Degree required.
5 years of experience in clinical research, regulatory, or data coordination required.
Experience with investigator-initiated and/or multisite research preferred.
ACRP/ SOCRA (or equivalent) certification preferred.
#Jobs-Indeed
Req ID : 8229
Working Title : Clinical Research Specialist II - Clinical Coordinating Center (CCC)
Department : Enterprise Research Admin
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $37.66 - $64.02
Senior Specialist 2, Environmental Health and Safety
Eikon Therapeutics Job In Millbrae, CA
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 seeking a seasoned and dedicated Senior Specialist 2, Environmental Health and Safety, to join our forward-thinking Environmental, Health, and Safety (EHS) team. As a Senior EHS Specialist 2, you will take on a leadership role in ensuring the safety, compliance, and sustainability of our operations. Your expertise and guidance will contribute significantly to the continued growth and success of our high-impact biotech endeavors.
About You
The ideal candidate for this role should have extensive knowledge of environmental regulations, safety protocols, hazardous materials management, and risk assessment methodologies. Exceptional leadership skills, meticulous attention to detail, and the ability to inspire and collaborate effectively within cross-functional teams are crucial. Strong communication skills are essential for clear interactions with team members, stakeholders, and regulatory authorities. Proficiency in utilizing EHS software tools, data management systems, and analytical techniques for comprehensive reporting and analysis is also required. Finally, dedication to promoting a culture of safety, sustainability, and compliance in a dynamic biotech environment is essential.
What You'll Do
Lead the strategic planning, development, and implementation of advanced EHS programs, policies, and procedures to ensure adherence to local, state, and federal regulations.
Conduct comprehensive risk assessments, detailed inspections, and thorough hazard evaluations to proactively minimize environmental and safety risks within our operations.
Collaborate seamlessly with cross-functional teams to design and deliver advanced EHS training programs, fostering a culture of safety, accountability, and compliance.
Oversee and optimize complex hazardous waste management and disposal processes, ensuring strict compliance with labeling, storage, and documentation requirements.
Play a central role in incident investigations, root cause analysis, and the formulation of comprehensive corrective and preventive action plans to mitigate potential risks.
Maintain precise and up-to-date EHS records, reports, and documentation to support compliance and reporting obligations.
Stay abreast of evolving EHS regulations, industry trends, and technological advancements, providing strategic insights and recommendations to enhance EHS strategies.
Qualifications
Ph.D. 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 Environmental Science, Occupational Health and Safety, or a related field is preferred.
Relevant professional certifications (e.g., CSP, CIH) or substantial experience in EHS field is highly advantageous.
Extensive knowledge of environmental regulations, safety protocols, hazardous materials management, and risk assessment methodologies.
Exceptional leadership skills, meticulous attention to detail, and the ability to inspire and collaborate effectively within cross-functional teams.
Strong communication skills, facilitating clear interactions with team members, stakeholders, and regulatory authorities.
Proficiency in utilizing EHS software tools, data management systems, and analytical techniques for comprehensive reporting and analysis.
Dedication to promoting a culture of safety, sustainability, and compliance in a dynamic biotech environment.
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 $117,000 to $128,250 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.
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.
Senior Medical Writer
Eikon Therapeutics Job In Millbrae, CA
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 seeking an experienced, detail-oriented individual to join our Medical Writing team. In the Senior Medical Writer role, you will be responsible for independently leading document development by authoring and editing of medical and regulatory writing deliverables that support the Eikon clinical portfolio. You will partner with cross functional colleagues within study teams/project teams to prepare high-quality, accurate and fit for use clinical and regulatory documents enabling delivery of Eikon portfolio milestones.
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), New York City (NYC) or Millbrae (CA) 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 an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing.
What You'll Do
Independently write clinical and regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules (Module 2.7.Xs, 2.5, and Module 5 integrated summaries), briefing documents, posters, abstracts, manuscripts and other documents per company and regulatory guidelines.
Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
Independently manage and maintain document lifecycle, including timelines, workflow of writing assignments, review cycle management, and document quality management where appropriate.
Help to iteratively improve medical writing processes as appropriate.
Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations.
Take ownership of a given assignment, proactively consulting other cross-functional project team members to align and build consensus on timelines, document interdependencies, organize and drive kick off meetings, comment resolution meetings, and ad-hoc meetings to mitigate risks and resolve project related issues.
Interpret and understand scientific and clinical data, provide input on data, figures, tables, and listings for clear data presentation per the document scope.
Qualifications
Doctoral-level degree in Life Sciences (e.g., Ph.D., M.D., PharmD; preferred), or Master's degree with 3+ years of relevant experience, or Bachelor's degree with 5+ years of relevant experience in regulatory, scientific, or medical writing.
Substantial clinical study protocol writing experience desired.
Excellent communication, presentation, and project management skills.
Ability to independently prepare clinical and regulatory documents (e.g., protocol, CSR, IB, CTD modules) in compliance with company SOPs and international health agencies/regulatory guidelines with a focus objective data presentation in a clear, concise format in keeping with industry guidelines.
Working knowledge of statistical concepts and techniques.
Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.
Strong understanding of federal regulations, GCPs, and ICH guidelines is a plus.
Understanding of clinical development, including study phases, submission processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., SharePoint, Veeva RIM, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote).
Familiarity with concepts of structured content management preferred.
Proven ability to work independently in a dynamic, fast-moving environment while striving for excellence in collaboration and innovation, as part of a cross-functional team.
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 $125,000 to $136,800 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.
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.
Eikon G&A Community
Eikon Therapeutics Job In Millbrae, CA
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.
If you can't find a specific G&A role to apply to but want to be part of our G&A talent community, join here.
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.
Infection Prevention Manager Exempt
Los Angeles, CA Job
CHA Hollywood Presbyterian (CHA HPMC) is a nationally recognized acute care facility that has been caring for the Hollywood community and Los Angeles Areas since 1924. Join our Global Network and be a CHA Global Ambassador CHA HPMC is also a part of the world-renown CHA Health System (CHS). CHS has CHA University which consists of 14 education institutions including medical school, nursing school and pharmacy. CHA global network operates 81 hospitals and specialty clinics, 30 research and 31 bio/pharmaceutical/healthcare companies with 14,000 employees in seven countries.
Our New Facility is seeking for Top Talents
The best women's hospital in Los Angeles is looking for current RN candidates to staff Operating Room, Emergency Department, Labor & Delivery and Mother-Baby care units to be housed in our expanding new patient tower facility scheduled to open next year. Come be a part of this dedicated and caring team right in the heart of Hollywood.
Position Summary:
Coordinates and manages the operations of the Infection Prevention Department, including identification, investigation, reporting, prevention and control of infections and communicable diseases within the organization, including both healthcare associated infections and community-acquired infections. Ensures quality patient care is given across the continuum. Directs performance improvement and continuous quality improvement (CQI) activities.
Provides coordination and management of the infection prevention department
Hires, completes performance management and development of staff within department(s).
Ensures quality care is delivered to patients in timely and effective manner.
Demonstrates knowledge of the principles of growth and development over the life span and the skills necessary to provide population specific care to the patients served. Ability to interpret data about patient's status in order to identify each patient's age specific needs and provide care needed by the patient group.
Maintains performance improvement and quality control activities. Provides education and guidance to staff on performance improvement. Able to plan, organize and participate in orientation and in service training for staff.
Ensures participation of facility personnel in the formulation of the standards of infection prevention practices. Implementing standards, annually reviewing and revising, as necessary, to reflect changes in practice.
Ensures compliance with Federal and State regulatory agencies including The Joint Commission and CDPH.
Develops and recommends department operational and capital budgets. Initiating corrective action for budget variances.
Develops and maintains a system for identifying, reporting investigating and controlling infections and communicable diseases of patients and staff.
The Infection Control Manager has comprehensive knowledge of the infection control process in the healthcare setting.
Assists in the development, implementation and improvement of infection prevention and control practices.
In collaboration with the Infection Preventions and Control Committee Chairperson, develops, reviews and/or revises and implements all department policies and procedures related to the control of infections and communicable diseases on a concurrent basis.
Demonstrates knowledge of risk stratified statistics as applicable to trending healthcare associated infections (HAIs).
Designs and implements new methods to improve the efficacy and outcomes of the Infection Prevention and Control Program
In coordination with the Infection Preventions and Control Committee, measures and evaluates the effectiveness of the Infection Prevention and Control Program.
Demonstrates knowledge of microbiology and modes of transmission of disease entities.
Demonstrates understanding of Standard Precautions and Transmission-Based Precautions as set forth by the CDC.
Demonstrates ability to teach principles and practical application of infection prevention and control to all levels of healthcare staff.
Is a consultant to nursing and medical staff.
Reviews cultures and sensitivities reported by microbiology laboratory of patients to determine if infection is healthcare associated in origin.
Confers with staff nurses on all patient care units on a regular basis to determine occurrence of healthcare associated infections (HAIs).
Confers with medical and nursing staff to determine appropriate implementation of Transmission-Based Precautions (isolation precautions). Investigates infections, especially those occurring above established thresholds, and/or in clusters by patient care units.
Supports and maintains a culture of safety and quality.
Performs all aspects of patient care in an environment that optimizes patient safety and reduces the likelihood of medical/health care errors.
Communicates appropriate reports to Performance Improvement through the Infection Prevention and Control Committee.
Assists with in service education related to infection prevention and control throughout the organization.
Completes required CMR reports to Public Health Department in a timely and accurate manner
Monitors proper use (manufacturers' instructions) of germicides, cleaning products, antiseptics and disinfectants in use throughout the facility.
Monitors methods of asepsis, sterilization and disinfection employed throughout the organization.
Communicates infection prevention and control activities to administration, Performance Improvement Committee, the medical staff and MEC via the Infection Prevention and Control Committee minutes and/or Infection Prevention and Control Committee Chairperson.
Prepares statistics and other pertinent data and reports to the Infection Prevention and Control Committee every month.
Implements and conducts special studies when appropriate or requested by the Infection Prevention and Control Committee Chairperson.
Based on studies which identify areas for improved patient outcomes, submits targeted surveillance indicators for Infection Prevention and Control Committee approval on an annual basis.
Stays abreast of changing infection prevention and control practices and presents plan for organizational compliance in a timely manner.
Designs and implements new methods to improve the efficacy and outcomes of the Infection Prevention and Control Program.
Minimum Education:
Bachelor's Degree in Public Health, Microbiology or Nursing is required.
Preferred Education:
N/A
Minimum Work Experience and Qualifications:
Ability to communicate effectively verbally and in writing.
Five years recent experience in similar position in acute healthcare setting.
Highly developed organizational skills.
Preferred Work Experience and Qualifications:
N/A
Required Licensure, Certification, Registration or Designation:
Current Los Angeles County Fire Card required (within 30 days of employment).
Assault Response Competency (ARC) (within 30 days of employment).
CIC preferred or obtain CIC within 2 years of appointment.
Membership in either APIC (Association of Professionals in Infection Control and Epidemiology) or SHEA (Society for Healthcare Epidemiology of America) preferred.
Shift: Day
Hours: 8:00am - 4:30pm
Shift Hours: 8
Weekly Hours: 40
Type: Exempt
FTE: 1.0
Postdoctoral Scientist - Urbanowicz Lab - Computational Biomedicine
Fresno, CA Job
Principal Investigator, Dr. Ryan Urbanowicz, is seeking a Postdoctoral Scientist to join the Department of Computational Biomedicine!
The primary focus of the URBS Lab (Unbounded Research in Biomedical Systems) is the development, evaluation and application of machine-learning (ML) and artificial intelligence (AI) tools/methods targeting various biomedical data types and problems. We develop and apply methods that (1) automate and provide rigor to machine-learning analyses, (2) can detect complex patterns of association, (e.g., epistasis and heterogeneity), (3) are interpretable/explainable to promote trust and translational adoption, as well as to identify and address sources of bias, (4) scale to “big data” and (5) flexibly adapt to common data challenges, (i.e., missing values, class imbalance, consideration of covariates). We aim to make ML and AI tools that are applicable to a wide variety of biomedical problems and that are accessible, reliable, reproducible, flexible, user-friendly, computationally efficient and transparent. Our lab holds particular interest in the research of rule-based ML, automated ML, feature selection and evolutionary algorithms. To learn more, please visit: Cedars-Sinai | Urbanowicz Lab
Are you ready to be a part of breakthrough research?
The URBS-lab focuses on the development and application of machine learning, artificial intelligence, and statistical methodologies targeting a variety of domains and data types within biomedical research. Emphasis is placed on developing methods that are interpretable/explainable, scalable to ‘big data', and capable of detecting complex patterns of association. Current research focuses on automated machine learning, rule-based modeling, feature selection, and evolutionary optimization. Other areas of interest include (but are not limited to) rare-variant analysis, data simulation, data integration, heterogeneous patient subgroup identification, time-series analysis, deep learning, and identifying and correcting for biases. We are a highly collaborative lab with access to EHR, genomic, and other ‘omics' data in areas of research such as obstructive sleep apnea, congenital heart disease, pancreatic cancer, transplantation donor-recipient matching, and hospital readmission.
Working independently but in close cooperation and in consultation with Dr. Ryan Urbanowicz and other research scientists, the Postdoctoral Scientist will perform routine and complex computational, mathematical, and statistical procedures throughout the training period. As a Postdoctoral Scientist you may develop, adapt, and implement new techniques, algorithms, analysis pipelines, and software, as well as analyze, interpret, summarize, and compile data.
Primary Duties and Responsibilities:
May assist in the preparation of grant proposals, but is not responsible for generating grant funds.
May participate in publications and presentations as author or co-author.
Designs and performs experiments. Will keep appropriate experimental records and documentation and analyze the results with the Principal Investigator.
Analyzes interpret, summarizes, and compiles data.
Operates and maintains equipment and instruments.
May observe MD-patient or MD-human research subject interactions as it pertains directly to research being performed.
Qualifications
Education:
Doctorate (MD, PhD, VMD, or DDS) in computer science, computational biology, data science, bioinformatics, biomedical informatics, biostatistics, engineering, or a related quantitative field is required.
Experience and Skills:
Competitive candidates will be proficient in scientific writing having published in more than one of the areas mentioned as well as experience with algorithm development/application.
Including a cover letter and publication examples (first authorship) are preferred, but not required.
Independently works on research projects designed in collaboration with one or more mentors within an area of specialization.
Acquires thorough technical and theoretical knowledge of research projects and objectives during one to five (1-5) year post-doctoral appointment.
Demonstrated aptitude to perform experimental protocols and procedures, including detailed data collection.
Knowledge of safety standards and maintenance of specialized equipment.
About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Req ID : 8644
Working Title : Postdoctoral Scientist - Urbanowicz Lab - Computational Biomedicine
Department : Computational Biomedicine
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Postdoctoral Scholar
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $62,400 - $93,600
Clinical Research Finance Coordinator II (Pre-Award): Remote Role
Remote or Beverly Hills, CA Job
Please note: Only candidates residing in the following states will be considered for remote work: California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia.
Cedars-Sinai is seeking a Clinical Research Finance Coordinator II (Pre-Award) to join our dynamic research team. In this role, you will be responsible for the financial management of clinical research studies during the pre-award phase. You will collaborate with principal investigators and study teams to develop and negotiate budgets, review contracts, and ensure compliance with institutional and sponsor regulations. This position requires strong attention to detail and expertise in research finance to support the successful launch of clinical studies.
The Clinical Research Budget Coordinator II develops complex clinical trial budgets for industry, National Institutes of Health (NIH), and investigator-initiated clinical research. Evaluates research protocols to assess resource needs, procedures, clinical research staff time, investigator time, and costs from ancillary departments. Determines cost allocation, negotiates budgets, details budgets, and responsible for monitoring accounts and invoicing. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Primary Duties and Responsibilities:
Works closely with investigators and ancillary departments to identify research procedures needed, budget estimates and cost details.
Evaluates complex research protocols to assess resource needs, research procedures, clinical research staff time, investigator time, and costs from ancillary departments.
Determines whether research procedures in the protocol are standard-of-care or a research-related costs in order to correctly classify expenses.
Develops complex clinical trial budgets for industry and the National Institutes of Health (NIH) as well as investigator-initiated clinical research. Works with the CSMC office of Sponsored Research to develop final budgets for clinical trials and research projects.
Negotiates trial budgets and payment terms with industry sponsors.
Monitors study accounts to evaluate the cost expenses/details are appropriate and within expected limits, reconciles accounts receivable and payments, and recommends the best course of action for any deficits and/or surpluses. Negotiates with sponsors the final payment due for account closeout. May conduct review and/or audits of clinical trial budgets. Serves as a resource for fiscal related questions and engages management as appropriate.
Responsible for invoicing sponsors, patient research billing, reimbursement to ancillary departments, and payment tracking. Issues and submits invoices for protocol-related items and patient-related expenses per the executed contract and internal invoices for staff time and effort allocation into study accounts. Works with sponsors and clinical teams to resolve queries regarding invoices and/or payments due.
Extracts and defines relevant information, analyzes and interprets data to determine financial performance and/or to project a financial probability and makes recommendations to influence business results. Prepares and delivers data, reports and/or presentations to investigators, management and/or leadership.
Enters financial information from finalized clinical trials budgets and clinical trial agreements into the Clinical Trial Management System. Reviews and finalizes clinical trials calendars to ensure agreement with Medicare coverage analysis and clinical trial budget.
Performs Medicare coverage analysis for clinical trials and collaborates with Institutional Review Board (IRB) to finalize and obtain approval.
Reviews protocol amendments for impact to sponsored research budget/contract. Process budget/contract amendments as applicable.
May provide training and education to other personnel.
May plan and coordinate strategies to improve existing standard operating procedures related to budgeting and clinical trials finance. May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
Qualifications
To be considered for the Clinical Research Finance Coordinator II (Pre-Award) position, applicants must have direct experience in a clinical research setting. This role requires a understanding of the financial aspects of clinical trials, including budget preparation, funding management, and financial reporting, all within the context of research projects. Applicants should have hands-on experience in pre-award processes, such as the preparation of grant proposals, contract negotiations, and coordination with internal and external stakeholders to ensure compliance with funding requirements. Prior experience working within a clinical research environment is essential to effectively manage the complexities of this role.
High School Diploma or equivalent experience/GED required. Bachelor's Degree Accounting, Finance, or other related degree preferred.
Minimum of 3 years of experience with billing, accounting, finance, budgeting, financial analysis or related field.
Minimum of 1 year of experience in clinical research.
Req ID : 6747
Working Title : Clinical Research Finance Coordinator II (Pre-Award): Remote Role
Department : Cancer - SOCCI Clinical Research
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Contract & Grant Budget/Fund
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $34.24 - $58.21
Director, Clinical Operations Study Management
Eikon Therapeutics, Inc. Job In Millbrae, CA
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
The Director of Clinical Operations Study Management will be responsible for overseeing the execution of multiple global clinical trials in oncology and other therapeutic areas, as required. You will lead a diverse team, ensuring the successful planning, coordination, and management of clinical trials in compliance with regulatory standards and company objectives. 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, New York 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 a collaborative, agile leader with significant oncology global clinical development experience, and have a passion for operational excellence, building and leading inhouse clinical operations and FSP study management teams. You possess a deep understanding of clinical trial regulations, guidelines, and the principles of Good Clinical Practice (GCP), ensuring strict 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 operational delivery of protocols.
* Oversee clinical study planning, execution, and closeout activities, ensuring compliance with all applicable regulations, guidelines, and company policies.
* Provide strategic guidance and direction to cross-functional study teams to ensure successful study execution.
* Ensure that clinical studies are conducted in accordance with approved protocols, ICH-GCP, EMEA, PMDA and other relevant regulations and guidelines.
* Manage study budgets, timelines, and resource allocation to ensure successful completion of studies.
* Develop and maintain strong relationships with study investigators, clinical vendors and other external partners.
* Provide regular updates on study progress to senior leadership and other stakeholders.
* Ensure that all study-related documents are accurate, complete, and filed appropriately.
* Serve as a talent magnet, to manage, develop, coach and retain top Clinical Operations talent in the study teams. Set clear performance standards and hold self and organization accountable for achieving high quality, high impact results. Embrace metrics and high-performance standards.
Qualifications
* Typically requires a minimum of 12+ years of experience with a Bachelor's degree, or 10+ years of experience with a post graduate degree
* Experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry highly preferred.
* Significant experience managing international clinical studies in oncology, and directly managing global Clinical Operations personnel.
* Demonstrated independence, problem-solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment. High emotional intelligence.
* Exceptional communication skills with an ability to efficiently and productively communicate both orally and in writing. Experience presenting to senior leadership is required.
* In-depth knowledge of ICH-GCP, EMEA, PMDA guidelines and other relevant regulations and guidelines.
* Proven ability to manage international clinical studies within timelines and budget while maintaining high quality standards and patient safety.
* Strong leadership, with a demonstrated ability to work collaboratively with cross-functional teams across diverse cultures and global regions.
* Management expertise should cover management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.
* Veeva clinical systems experience preferred.
* MS Project experience 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 $226,000 to $247,000 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.
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.
Senior Manager, Clinical Data Management
Eikon Therapeutics Job In Millbrae, CA
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 recruiting a Senior Manager, Clinical Data Management (Data Management Lead) who is responsible for timely and high-quality data management deliverables supporting the Eikon portfolio.
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), New York (NY), or Millbrae (CA) 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 a driven individual that focuses on detail. An expert in data management and a strong collaborator.
What You'll Do
Provide clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects.
Efficiently plan, coordinate, and deliver complete, high quality and reliable clinical trial data in a timely manner for assigned projects.
Responsible for end-to-end clinical data management activities and serve as a primary point of contact for internal and external study team members.
Provide strong quality and project oversight over third party vendor responsible for data management deliverables.
Take a leadership role to gather content and integration requirements for EDC and closely collaborate with partners supporting other data collection systems (eCOA, External Data, RTSM). Enforce data standard conventions and quality expectations for clinical data per defined processes.
Author, review/revise DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines, and other study documents to ensure quality and standardization.
Chair Data Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness.
Represent DM on cross-functional project teams & submission teams.
Lead or support the Health Authority inspections and audits.
Provide coaching and quality oversight of junior Data Management Leads
Act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manage data currency throughout the trial, and perform overall monitoring DM deliverables according to the Service Level Agreement (SLA).
Lead/provide the relevant support to set up, validate the standard eCRF library.
Qualifications
Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant field such as Life Sciences, Biostatistics, Computer Science, or a related discipline
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 and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
Oncology experience required
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.
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.
Strong project management; Exhibits expertise in metrics analysis and reporting methodologies.
Excellent oral and written communication skills.
Communicate effectively with senior management and cross-functional teams.
Deep 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)].
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 $152,000 to $166,250 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.
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.
Senior Specialist 2, Environmental Health and Safety
Eikon Therapeutics, Inc. Job In Millbrae, CA
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 seeking a seasoned and dedicated Senior Specialist 2, Environmental Health and Safety, to join our forward-thinking Environmental, Health, and Safety (EHS) team. As a Senior EHS Specialist 2, you will take on a leadership role in ensuring the safety, compliance, and sustainability of our operations. Your expertise and guidance will contribute significantly to the continued growth and success of our high-impact biotech endeavors.
About You
The ideal candidate for this role should have extensive knowledge of environmental regulations, safety protocols, hazardous materials management, and risk assessment methodologies. Exceptional leadership skills, meticulous attention to detail, and the ability to inspire and collaborate effectively within cross-functional teams are crucial. Strong communication skills are essential for clear interactions with team members, stakeholders, and regulatory authorities. Proficiency in utilizing EHS software tools, data management systems, and analytical techniques for comprehensive reporting and analysis is also required. Finally, dedication to promoting a culture of safety, sustainability, and compliance in a dynamic biotech environment is essential.
What You'll Do
* Lead the strategic planning, development, and implementation of advanced EHS programs, policies, and procedures to ensure adherence to local, state, and federal regulations.
* Conduct comprehensive risk assessments, detailed inspections, and thorough hazard evaluations to proactively minimize environmental and safety risks within our operations.
* Collaborate seamlessly with cross-functional teams to design and deliver advanced EHS training programs, fostering a culture of safety, accountability, and compliance.
* Oversee and optimize complex hazardous waste management and disposal processes, ensuring strict compliance with labeling, storage, and documentation requirements.
* Play a central role in incident investigations, root cause analysis, and the formulation of comprehensive corrective and preventive action plans to mitigate potential risks.
* Maintain precise and up-to-date EHS records, reports, and documentation to support compliance and reporting obligations.
* Stay abreast of evolving EHS regulations, industry trends, and technological advancements, providing strategic insights and recommendations to enhance EHS strategies.
Qualifications
* Ph.D. 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 Environmental Science, Occupational Health and Safety, or a related field is preferred.
* Relevant professional certifications (e.g., CSP, CIH) or substantial experience in EHS field is highly advantageous.
* Extensive knowledge of environmental regulations, safety protocols, hazardous materials management, and risk assessment methodologies.
* Exceptional leadership skills, meticulous attention to detail, and the ability to inspire and collaborate effectively within cross-functional teams.
* Strong communication skills, facilitating clear interactions with team members, stakeholders, and regulatory authorities.
* Proficiency in utilizing EHS software tools, data management systems, and analytical techniques for comprehensive reporting and analysis.
* Dedication to promoting a culture of safety, sustainability, and compliance in a dynamic biotech environment.
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 $117,000 to $128,250 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.
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.
Senior Director, Clinical Research - Oncology
Eikon Therapeutics Job In Millbrae, CA
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 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 New Jersey or New York offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
What You'll Do
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.
Work closely with biomarker, discovery, and translational research scientists.
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.
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.
Establish strong working relationships and collaborations with external study investigators, key opinion leaders in drug development, and external alliance partners.
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.
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.
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.
Significant experience in clinical practice with direct patient care (preferably in Oncology)
Proven track record in leading clinical trials, including medical monitoring of early and late clinical trials and managing complex projects.
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 and external partners.
Passion for innovation and improving patient outcomes.
Experience with IND and/or NDA 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.
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.
Postdoctoral Scientist - Urbanowicz Lab - Computational Biomedicine
Modesto, CA Job
Principal Investigator, Dr. Ryan Urbanowicz, is seeking a Postdoctoral Scientist to join the Department of Computational Biomedicine!
The primary focus of the URBS Lab (Unbounded Research in Biomedical Systems) is the development, evaluation and application of machine-learning (ML) and artificial intelligence (AI) tools/methods targeting various biomedical data types and problems. We develop and apply methods that (1) automate and provide rigor to machine-learning analyses, (2) can detect complex patterns of association, (e.g., epistasis and heterogeneity), (3) are interpretable/explainable to promote trust and translational adoption, as well as to identify and address sources of bias, (4) scale to “big data” and (5) flexibly adapt to common data challenges, (i.e., missing values, class imbalance, consideration of covariates). We aim to make ML and AI tools that are applicable to a wide variety of biomedical problems and that are accessible, reliable, reproducible, flexible, user-friendly, computationally efficient and transparent. Our lab holds particular interest in the research of rule-based ML, automated ML, feature selection and evolutionary algorithms. To learn more, please visit: Cedars-Sinai | Urbanowicz Lab
Are you ready to be a part of breakthrough research?
The URBS-lab focuses on the development and application of machine learning, artificial intelligence, and statistical methodologies targeting a variety of domains and data types within biomedical research. Emphasis is placed on developing methods that are interpretable/explainable, scalable to ‘big data', and capable of detecting complex patterns of association. Current research focuses on automated machine learning, rule-based modeling, feature selection, and evolutionary optimization. Other areas of interest include (but are not limited to) rare-variant analysis, data simulation, data integration, heterogeneous patient subgroup identification, time-series analysis, deep learning, and identifying and correcting for biases. We are a highly collaborative lab with access to EHR, genomic, and other ‘omics' data in areas of research such as obstructive sleep apnea, congenital heart disease, pancreatic cancer, transplantation donor-recipient matching, and hospital readmission.
Working independently but in close cooperation and in consultation with Dr. Ryan Urbanowicz and other research scientists, the Postdoctoral Scientist will perform routine and complex computational, mathematical, and statistical procedures throughout the training period. As a Postdoctoral Scientist you may develop, adapt, and implement new techniques, algorithms, analysis pipelines, and software, as well as analyze, interpret, summarize, and compile data.
Primary Duties and Responsibilities:
May assist in the preparation of grant proposals, but is not responsible for generating grant funds.
May participate in publications and presentations as author or co-author.
Designs and performs experiments. Will keep appropriate experimental records and documentation and analyze the results with the Principal Investigator.
Analyzes interpret, summarizes, and compiles data.
Operates and maintains equipment and instruments.
May observe MD-patient or MD-human research subject interactions as it pertains directly to research being performed.
Qualifications
Education:
Doctorate (MD, PhD, VMD, or DDS) in computer science, computational biology, data science, bioinformatics, biomedical informatics, biostatistics, engineering, or a related quantitative field is required.
Experience and Skills:
Competitive candidates will be proficient in scientific writing having published in more than one of the areas mentioned as well as experience with algorithm development/application.
Including a cover letter and publication examples (first authorship) are preferred, but not required.
Independently works on research projects designed in collaboration with one or more mentors within an area of specialization.
Acquires thorough technical and theoretical knowledge of research projects and objectives during one to five (1-5) year post-doctoral appointment.
Demonstrated aptitude to perform experimental protocols and procedures, including detailed data collection.
Knowledge of safety standards and maintenance of specialized equipment.
About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Req ID : 8644
Working Title : Postdoctoral Scientist - Urbanowicz Lab - Computational Biomedicine
Department : Computational Biomedicine
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Postdoctoral Scholar
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $62,400 - $93,600
Clinical Trial Associate, Oncology
Eikon Therapeutics, Inc. Job In Millbrae, CA
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
As a Clinical Trials Associate in Oncology, you will play a crucial role in supporting the planning, coordination, and execution of Phase I-III insourced global clinical studies within the oncology portfolio. Operating in a dynamic and collaborative environment, you will provide essential support for the execution of clinical trials, contributing to the development of groundbreaking therapies with the potential to transform patient lives.
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), New York City (NYC) or Millbrae (CA) 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 passionate about playing a key role in supporting the planning, coordination, and execution of clinical trials within the oncology portfolio. You have strong communication skills and a passion for advancing care to patients.
What You'll Do
* Assist in the preparation and maintenance of essential study documents, including study protocols, informed consent forms, case report forms (CRFs), and other trial-related materials
* Collaborate with cross-functional teams to ensure accurate and timely completion of study start-up activities, such as site selection, feasibility assessments, and ethics committee submissions
* Support the organization and conduct of investigator meetings, study initiation visits, and other trial-related meetings
* Coordinate and track the distribution, collection, and reconciliation of trial supplies, investigational products, and study related materials
* Assist in the review and resolution of data queries, ensuring data accuracy and completeness within electronic data capture (EDC) systems
* In collaboration with TMF Operations team, maintain trial master files (TMFs) and study documentation in accordance with regulatory requirements and internal SOPs
* Facilitate effective communication among study team members, investigators, and study site personnel through regular correspondence and timely dissemination of study-related information
* Support the monitoring and tracking of study progress, including patient recruitment and enrollment, to ensure adherence to study timelines and milestones
* In collaboration with other Clinical Operations groups (Site Engagement and Monitoring Excellence) assist, as necessary, in the preparation and coordination of site monitoring visits, ensuring compliance with monitoring plans and resolution of site-related issues
* Stay updated with relevant regulations, guidelines, and industry best practices pertaining to oncology clinical trials, ensuring compliance, and implementing necessary changes as required
Qualifications
* An Advanced Degree without experience or Bachelor's degree with 2 years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline)
* Ability to communicate in multiple languages (especially European languages) will be considered a strong asset
* Previous experience working as a Clinical Trials Associate, Study Coordinator, or in a similar role within the pharmaceutical, biotechnology, or CRO industry is preferred
* Knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements
* Strong organizational skills and attention to detail, with the ability to manage multiple tasks and prioritize workload effectively
* Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems
* Excellent written and verbal communication skills, with the ability to effectively interact with study team members and internal / external stakeholders
* Ability to work independently as well as collaboratively in a team-oriented environment
* Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project)
* Adaptability and willingness to learn and embrace new technologies, processes, and industry trends
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.
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.
Associate Director, Clinical Scientist
Eikon Therapeutics, Inc. Job In Millbrae, CA
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 seeking a Clinical Scientist that will lead the scientific planning and collaborate with both Clinical Research, Pharmacovigilance and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a cross-functional clinical development team. You will be a key contributor in the clinical science activities of evidence generation for regulatory approval and/or engagement with physicians, including protocol development, study implementation, data analysis and reporting of results.
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), New York City (NYC) or Millbrae (CA) 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 a data driven and collaborative integrator that is passionate about driving development and execution of therapeutic strategy that enables innovative pipeline impact and delivery of transformative medicines to patients. You have exemplary communication and presentation skills and can lead study development by applying the most current electronic document conventions/processes consistently to ensure scientific and data integrity.
What You'll Do
* Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). This may include:
* Serving as the lead clinical scientist on the clinical trial team
* Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance
* Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); partnering with Clinical Operations on study deliverables
* Ensure CRF design supports data collection in alignment with the Protocol in collaboration with Clinical Data Management/Programming
* Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct
* Providing tactical/scientific mentorship to other clinical scientists
* Responsible for assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate)
* Apply proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identifies risks and designs mitigation strategies
* Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs.
Qualifications
* 10+ years of experience with a Bachelor's degree, or 8+ years with a post graduate degree
* Experience in clinical drug development experience, or a PhD, Pharm D, or RN degree is preferred.
* Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
* Ability to manage multiple competing priorities with good planning, time management and prioritization skills
* Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions
* Proficient scientific expertise to propose, design, and execute clinical research and development studies, and authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports
* Interact with key stakeholders across Clinical Development functional areas
* Role requires proactive approach, strategic thinking and leadership in driving toward clinical study goals
* Influence opinions and decisions of internal and external customers / vendors, across functional areas
* Problem solving, prioritization, conflict resolution and critical thinking skills
* Strong communication, technical writing, and presentation skills experience
* Experience within oncology 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 $189,000 to $206,150 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.
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.
Director, Financial Planning & Analysis
Eikon Therapeutics, Inc. Job In Millbrae, CA
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 Summary
We are seeking a Director, Financial Planning & Analysis (FP&A) to lead financial reporting, budgeting, forecasting, and process optimization at Eikon. Reporting to the Executive Director, Finance, you will play a critical role in ensuring financial accuracy, enhancing operational efficiency, and providing strategic insights that support decision-making across the organization.
This role is an opportunity to shape financial strategy, drive operational improvements, and work cross-functionally with teams including Research, Engineering, and Operations.
About You
You are a seasoned finance leader with deep expertise in financial planning and analysis within the biotech, pharmaceutical, or healthcare industries. You have a strategic mindset, technical expertise, and a keen eye for process improvement. Your ability to transform complex financial data into clear, actionable insights makes you a trusted partner to senior leadership. You thrive in fast-paced, high-growth environments and excel at fostering collaboration across functions.
Key Responsibilities
* Develop & Implement Financial Strategy - Align financial planning with Eikon's business objectives to drive sustainable growth.
* Lead Budgeting & Long Range Planning Processes - Ensure accuracy and efficiency in financial planning using data-driven insights and predictive modeling.
* Optimize Financial Reporting & Performance Management - Develop key performance indicators (KPIs), financial scorecards, and business review frameworks.
* Collaborate on Corporate Finance Initiatives - Partner with Executive management on capital formation initiatives and partner with the Business Development team on licensing and partnership opportunities
* Enhance Financial Governance & Compliance - Maintain internal financial controls, ensure regulatory compliance, and uphold industry best practices.
* Support Decision-Making with Actionable Insights - Deliver financial reports that highlight risks, opportunities, and trends for executive leadership.
* Streamline Financial Operations - Drive efficiency in budgeting, accruals, and reporting processes to enhance reliability and reduce cycle times.
* Strengthen Cross-Functional Collaboration - Partner with Research, Engineering, and other teams to align financial strategies with operational needs.
* Leverage Advanced FP&A Tools & Systems - Utilize Anaplan and other financial platforms to improve forecasting, reporting, and resource allocation.
* Improve Cost Transparency & Resource Allocation - Ensure financial data is clear, reliable, and supports strategic business decisions.
Qualifications & Experience
* 12+ years of experience with a Bachelor's Degree or 10+ years of experience with a post graduate degree in financial planning, analysis, or accounting, preferably within biotech, pharma, or healthcare.
* Bachelor's degree in finance, accounting, or a related field (MBA and/or CPA preferred but not required).
* Strong technical and analytical skills - Expertise in Anaplan, financial modeling, and data visualization tools.
* Proven experience in process optimization - Ability to improve financial workflows, enhance reporting accuracy, and drive efficiency.
* Flawless attention to detail - Skilled in managing complex financial data with precision.
* Excellent business acumen & collaboration skills - Ability to work cross-functionally and align finance with organizational priorities.
* Effective communication and reporting - Capable of presenting clear, concise financial insights to senior executives.
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 $204,000 to $223,250 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.
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.
Clinical Research Coordinator II (Hybrid)
Modesto, CA Job
This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.
The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures. In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Maintains accurate source documents related to all research procedures.
Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
Schedules and participates in monitoring and auditing activities. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct. Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
May coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators
Participates in required training and education programs.
Qualifications
This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.
Requirements:
High School Diploma/GED required. Bachelor's Degree Science, Sociology or related degree preferred.
2 years Clinical research related experience required.
#Jobs-Indeed
Req ID : 8277
Working Title : Clinical Research Coordinator II (Hybrid)
Department : Cancer - SOCCI Clinical Research
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $28.30 - $48.11
Senior Director, Computational Biology
Eikon Therapeutics Job In Millbrae, CA
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 seeking an accomplished and visionary Senior Director of Computational Biology to provide strategic leadership and shape transformative projects that leverage the synergy between biology, data and technology. In this pivotal role, you will drive our computational biology and data strategy in support of target discovery, drug discovery, biomarker development and biological mechanism. You will leverage your strong computational background to analyze complex biological data, build out rigorous workflows, and set the strategic direction in leveraging Eikon's unique biological data sets. The ideal candidate will have a proven track record of integrating computational biology with experimental research to drive innovation and achieve significant scientific breakthroughs, making substantial contributions to our mission.
About You
The unique candidate for this role is an exceptional scientific leader with a proven track record in drug discovery and computational biology to drive target identification and translational biology. This candidate has leadership experience in drug discovery with demonstrated ability to conceive, lead and execute computational analyses at the intersection of biology and technology. They demonstrate proficiency in advanced computational tools such as machine learning and high dimensional analysis relevant to cutting-edge biological research. Their exceptional analytical skills enable them to interpret and communicate intricate scientific insights effectively, utilizing their outstanding communication skills, allowing for the clear conveyance of complex scientific concepts to diverse audiences.
What You'll Do
Build a team of computation biologists who will work alongside our wet-lab biologist and software engineers to drive our research and drug discovery pipeline forward.
Derive insights and develop testable hypotheses by building sophisticated analysis processes from complex data sets.
Provide strategic leadership in designing and executing complex analyses and studies at the intersection of biology and technology.
Apply advanced scientific methodologies and computational tools to interpret and analyze intricate experimental data from proprietary single molecule tracking tools.
Develop strategies to explore disease insights from human datasets to generate and inform therapeutic hypotheses.
Mentor and collaborate with researchers at all levels, fostering a collaborative and innovative scientific environment.
Stay current with scientific and data science advancements, integrating relevant knowledge into computational biology.
Present computational biology findings and strategic recommendations to senior leadership and stakeholders, and drive publication in high-impact peer-reviewed journals.
Prepare comprehensive and precise documentation of computational biology analysis, contributing to internal reports, presentations, and potential intellectual property.
Qualifications
Post Graduate degree with 12+ years of relevant experience or a Bachelor's degree with 15+ years of relevant experience in Biology, Computational Biology, Bioinformatics or a closely related field, with a distinguished record of impactful research.
Strong scientific background with the ability to translate leading edge technology into drug discovery with strong experience at the interface of computational biology and drug discovery.
Strong record of drug discovery success; a mixture of Biotechnology and Pharma experience preferred.
Demonstrated ability to collaborate across the organization while still being decisive and able to drive the research vision, strategy, and execution to deliver results aligned with the company's objectives.
Able to build, lead and inspire.
Exceptional team player attitude and values-based leader who demonstrates the highest level of integrity, authenticity and transparency.
Intellectually curious; culture carrier who can bring along teams through significant stages of growth and development at the company.
Agile with the ability to deliver in a high-growth environment.
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 $239,000 to $261,250 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.
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.