Current jobs related to Manager, Study Start Up - Hayward - Eikon Therapeutics
-
Hayward, United States Eikon Therapeutics Full timeEikon 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...
-
Hayward, United States Eikon Therapeutics Full timeEikon 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...
-
Clinical Trial Manager, Oncology
1 month ago
Hayward, United States Eikon Therapeutics Full timeEikon 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...
-
Clinical Trial Manager, Oncology, EMEA
2 months ago
Hayward, United States Eikon Therapeutics Full timeEikon 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...
-
Clinical Program Manager, Oncology, Asia
1 month ago
Hayward, United States Eikon Therapeutics Full timeEikon 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...
-
Clinical Program Manager, Oncology, EMEA
2 months ago
Hayward, United States Eikon Therapeutics Full timeEikon 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...
-
Senior Clinical Trial Manager, Oncology
1 week ago
Hayward, United States Eikon Therapeutics Full timeEikon 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...
-
Hayward, United States Eikon Therapeutics Full timeEikon 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...
-
Hayward, California, United States Arcus Biosciences Full timePosition Overview: As a Senior Manager within the Vendor Management and Outsourcing team, you will play a crucial role in overseeing the outsourcing requirements for ongoing and upcoming clinical studies. This includes responsibilities such as vendor identification, request for proposals (RFPs), vendor selection, contract negotiations, budget management, and...
-
Hayward, United States Eikon Therapeutics Full timeEikon 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...
-
Entry-level Information Technology
1 month ago
Hayward, United States Year Up Careers Full timeYear Up is a one-year or less, intensive job training program that provides young adults with in-classroom skill development, access to internships and/or job placement services, and personalized coaching and mentorship. Year Up participants also receive an educational stipend.The program combines technical and professional training with access to...
-
Entry-level Business Operations Specialist
3 weeks ago
Hayward, California, United States Year Up Careers Full timeAbout Year Up CareersYear Up Careers is a one-year or less, intensive job training program that provides young adults with in-classroom skill development, access to internships and/or job placement services, and personalized coaching and mentorship. Our program combines technical and professional training with access to internships and job placement support...
-
Early Head Start Teachers
4 months ago
Hayward, United States Cape Inc Community Association for Pre-School Full timeJob DescriptionJob DescriptionDescription:CAPE, Inc. has a wonderful opportunity for Full Time Teachers: 3Early Head Start (EHS)Eligible for Hiring Bonus!!!• Position is Non-Exempt, Full Time (40 hours/week)• Pay Rate: Commensurate with related experience, education and permit level:Minimum $22.00/hour without a degree; Maximum $28.16/hour with 4-year...
-
Senior Manager, Clinical Site Payment
2 months ago
Hayward, United States Eikon Therapeutics Full timeEikon 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...
-
Clinical Trial Associate, Oncology, Asia
1 month ago
Hayward, United States Eikon Therapeutics Full timeEikon 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...
-
Regulatory Affairs Senior Manager
3 days ago
Hayward, California, United States Arcus Biosciences Full timeSenior Manager, Regulatory AffairsThe Senior Manager, Regulatory Affairs will be responsible for developing and implementing regulatory strategies to ensure compliance with U.S. FDA and global regulatory bodies. This role will provide direct support for regulatory submissions in the US, APAC, and other regions.Key Responsibilities:Manage the preparation,...
-
Regulatory Affairs Senior Manager
2 hours ago
Hayward, California, United States Arcus Biosciences Full timeJob Title: Senior Manager, Regulatory AffairsAt Arcus Biosciences, we are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and managing regulatory strategies to ensure compliance with U.S. FDA and global regulatory bodies.Key...
-
Research Associate
3 weeks ago
Hayward, California, United States Frontage Laboratories Full timeJob SummaryWe are seeking a highly skilled Research Associate - Bioanalytical Scientist to join our team at Frontage Laboratories. As a key member of our bioanalytical department, you will be responsible for performing various tasks related to study protocols, method development, and validation studies.Key ResponsibilitiesStudy Protocol Execution: Perform...
-
Research Associate
3 weeks ago
Hayward, California, United States Frontage Laboratories Full timeJob SummaryWe are seeking a highly skilled Research Associate - Bioanalytical Scientist to join our team at Frontage Laboratories. As a key member of our bioanalytical department, you will be responsible for performing various tasks related to study protocols, method development, and validation studies.Key ResponsibilitiesStudy Protocol Execution: Perform...
-
Project Manager
1 week ago
Hayward, United States Heat and Control Full timeOnsite Project Manager Heat and Control, one of the world's leading manufacturers of food processing, seasoning, conveying, packaging and inspection equipment systems, are seeking a Project Manager to identify potential commercial and technical issues and work with sales teams to negotiate with customers.Project Manager Job Responsibilities IncludeSet up and...
Manager, Study Start Up
3 months ago
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
We are currently seeking an experienced, collaborative, detail oriented Manager, Study Start Up expert. In this role you will work with the Senior Director, Study Start Up and the clinical trial teams to improve operational excellence and efficiency of clinical trial execution in study and site start up across all phases of Clinical Development activities at Eikon Therapeutics by: Driving study feasibility deliverables and providing data driven recommendations to accelerate clinical trials and Supporting Clinical Development Operations Study Planning: to ensure proper planning and timely execution of all clinical trials in alignment with timelines and quality standards.
About You
You are collaborative and passionate about unlocking hidden insights in today’s clinical operations landscape and relentless in your pursuit of operational excellence.
What You’ll Do
- Working closely with Clinical Development R&D functions, enhance analytic capabilities to ensure the right questions are being asked and data is being leveraged to drive study feasibility deliverables and provide data driven recommendations to accelerate our clinical trials in study design and study start up
- Engage and develop strong working relationships with clinical study teams (e.g., Clinical Operations, Clinical Supply, Legal, Regulatory, Clinical IT, Clinical R&D Process and Learning Management, Clinical Project and Portfolio Management, Clinical Quality Assurance, Clinical Data Management, and Clinical Research) to generate the best outcomes for study and site start up activities
- Drive adherence to standards for planning and execution of study start up, country requirements, working in collaboration with Clinical Operations on site information management activities to ensure time critical and high-quality delivery of study specific needs
- Partnering with Clinical Operations and clinical trial team, ensure the real time collection of information that informs country allocation, investigator site identification through activation, forecasting and planning and contributes to accurate site activation deliverables
- Support the Clinical Operation team in the successful execution of clinical trials, from protocol concept to Site Activation, complying with ICH / GCP / EMEA guidelines and regulations and SOPs
- Ensure that selected sites are meeting or exceeding all study start up requirements leading to Site Activation. This includes gathering and monitoring start up metrics to measure against KPIs
- As required, develop site budgets & contracts, establish achievable finalization target dates and support the negotiations process leveraging FMV. Engage Legal and Finance as deemed necessary.
- Collect and summarize data and study start up insights for Clinical Operations and clinical trial team’s consideration to improve Study Start Up turn around times.
- Create, manage and archive central start up team tools (e.g., investigator database, clinical site intelligence, etc.) and resources required to support start up team daily operations, communications and records from study assignment to final handoff
- Proactively identify and implement best study start up practices, seeking continuous process improvement
- Facilitate study start up forum discussions
- Support in the development of local workflows to streamline output and deliverables
- Support Clinical Development Operations in driving a partnering mindset.
Qualifications
- Post Graduate degree with 4+ years of experience or a Bachelor's degree with 6+ years of experience in a relevant field (e.g., life sciences, healthcare, or related discipline).
- Solid understanding of US and global regulations and guidelines (e.g., FDA, EMEA, ICH) applicable to clinical development
- Significant experience within the pharmaceutical industry or clinical research organization (CRO) working with clinical data and clinical development processes
- Deep understanding of complexities of study start up
- Strong analytical and project management skills
- Able to rapidly adapt to changes in the work environment, manage competing demands and change approach or method to achieve optimal fit-for-purpose solution
- Excellence in driving results. You persist in accomplishing objectives and exceeding goals despite obstacles and setbacks, while also helping others to achieve results
- Excellent verbal / written communication and collaboration skills and ability to influence and build effective relationships in a matrix organization, including to to ensure timely follow-up, issue resolution, and report updates
- Experience with Veeva clinical solutions and familiarity with leveraging multiple technologies.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
- 401k plan with company matching
- Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
- Mental health and wellness benefits
- Weeklong summer and winter holiday shutdowns
- Generous paid time off and holiday policies
- Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
The expected salary range for this role is $130,000 to $142,500 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
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.
