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Endpoints News
Endpts.com is a leading online news source for the biotech and pharmaceutical industry. The website covers a wide range of topics including drug development, clinical trials, regulatory updates, and market analysis. With a team of experienced journalists and industry experts, Endpts.com provides readers with timely and informative articles that are essential for staying informed on the latest trends and developments in the biotech and pharmaceutical sectors. Whether you are a researcher, investor, or industry professional, Endpts.com is a valuable resource for staying up to date on the latest news and insights in the field.
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Newest job postings for Endpoints News
via Endpoints Careers
schedule_type: Full-time
COMPANY:
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation...
Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal
COMPANY:
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation...
Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.
SUMMARY:
As we continue to grow, we are seeking a (Sr) Director, Regulatory CMC. The (Sr.) Director, Regulatory CMC will assist in defining strategy and assist (when necessary) with execution for our companies working with our seven large molecule programs (antibodies and peptide/protein expression). The Regulatory (Sr.) Director will have the knowledge of CMC processes (and regulatory requirements) and have a solid understanding of the duration, timing and execution of required activities. The objective is to guide and assist our programs in order of execution such that preventable delays waiting for CMC deliverables are avoided.
RESPONSIBILITIES:
• Identification and resolution of technical challenges in the areas of drug substance process development and manufacturing, drug product formulation development, drug product process development, manufacturing, and packaging, analytical method development, and technology transfer
• Creation and execution of CMC development plans for new products; ability to manage regulatory submissions and project manage these submissions with the Technical Operations team and associated CMOs
• Assistance in the creation and execution of process (drug substance and drug product) and analytical method validation plans
• Coordination with supply chain and clinical operations groups for production of clinical trial materials
• Assistance in batch record review, as required
• Assistance in deviation investigations, as required (assess regulatory impact for deviations and change controls)
• Assistance in the writing, preparation, and review of regulatory documentation
• Assistance in due diligence technical assessments of potential new products
QUALIFICATIONS:
• Thorough understanding of cGMP requirements for pharmaceutical products
• Strong organizational, analytical and interpersonal skills
• Ability to work independently in a fast-paced dynamic environment with multiple projects
• Demonstrated ability to coordinate CMO activities in the development and commercialization of pharmaceutical products
• Strong decision-making and analytical skills
• Excellent organizational skills, project management skills and detail-orientated leadership approach
EXPERIENCE:
• MS or Ph.D. in chemistry, pharmaceutical sciences, or related field preferred
• 5-7 years of direct experience with pharmaceutical product development
• Experience in sterile fill/finish of drug product for clinical studies
• Experience in Supply Chain requirements and timing (packaging/labeling is a plus but not mandatory as well as a deep understanding of GMP regulations)
• Must have experience working with CMOs and a solid knowledge of analytical method development/validation
POSITION: Full-Time, Exempt
EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law Show more details...
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation...
Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.
SUMMARY:
As we continue to grow, we are seeking a (Sr) Director, Regulatory CMC. The (Sr.) Director, Regulatory CMC will assist in defining strategy and assist (when necessary) with execution for our companies working with our seven large molecule programs (antibodies and peptide/protein expression). The Regulatory (Sr.) Director will have the knowledge of CMC processes (and regulatory requirements) and have a solid understanding of the duration, timing and execution of required activities. The objective is to guide and assist our programs in order of execution such that preventable delays waiting for CMC deliverables are avoided.
RESPONSIBILITIES:
• Identification and resolution of technical challenges in the areas of drug substance process development and manufacturing, drug product formulation development, drug product process development, manufacturing, and packaging, analytical method development, and technology transfer
• Creation and execution of CMC development plans for new products; ability to manage regulatory submissions and project manage these submissions with the Technical Operations team and associated CMOs
• Assistance in the creation and execution of process (drug substance and drug product) and analytical method validation plans
• Coordination with supply chain and clinical operations groups for production of clinical trial materials
• Assistance in batch record review, as required
• Assistance in deviation investigations, as required (assess regulatory impact for deviations and change controls)
• Assistance in the writing, preparation, and review of regulatory documentation
• Assistance in due diligence technical assessments of potential new products
QUALIFICATIONS:
• Thorough understanding of cGMP requirements for pharmaceutical products
• Strong organizational, analytical and interpersonal skills
• Ability to work independently in a fast-paced dynamic environment with multiple projects
• Demonstrated ability to coordinate CMO activities in the development and commercialization of pharmaceutical products
• Strong decision-making and analytical skills
• Excellent organizational skills, project management skills and detail-orientated leadership approach
EXPERIENCE:
• MS or Ph.D. in chemistry, pharmaceutical sciences, or related field preferred
• 5-7 years of direct experience with pharmaceutical product development
• Experience in sterile fill/finish of drug product for clinical studies
• Experience in Supply Chain requirements and timing (packaging/labeling is a plus but not mandatory as well as a deep understanding of GMP regulations)
• Must have experience working with CMOs and a solid knowledge of analytical method development/validation
POSITION: Full-Time, Exempt
EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law Show more details...
via Salary.com
schedule_type: Full-time
SUMMARY
Imaging Endpoints (IE) is an Imaging Clinical Research Organization (iCRO) that also provides comprehensive CRO and Site Management Organization (SMO) services for image-centric trials. We are...
based in Scottsdale, Arizona and are an affiliate of the Scottsdale Healthcare Network, one of the 50 largest healthcare systems nationally, and an affiliate of Scottsdale Medical Imaging Limited (SMIL), ranked as the 4th largest private radiology
SUMMARY
Imaging Endpoints (IE) is an Imaging Clinical Research Organization (iCRO) that also provides comprehensive CRO and Site Management Organization (SMO) services for image-centric trials. We are...
based in Scottsdale, Arizona and are an affiliate of the Scottsdale Healthcare Network, one of the 50 largest healthcare systems nationally, and an affiliate of Scottsdale Medical Imaging Limited (SMIL), ranked as the 4th largest private radiology group in the US. Our experience extends from translational to phase III and IV studies and every step in between.
The Imaging Specialist is primarily responsible for conducting a variety of QC/analysis procedures. This person is responsible for reviewing the imaging data received from clinical trial imaging sites/sponsors to confirm specific protocol requirements have been met as well as ensuring technical adequacy and data integrity. In additional this person will assist in project management duties within the operations department and serve as imaging technical support for internal and external staff.
RESPONSIBILITIES
• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Perform Imaging data reconstruction per trial specifications
• Manage research projects and early phase clinical trials for day-day activities
• Compel quality control documentation according to standard operating procedures
• Develop quality control documentation in conjunction with the Project Manager
• Generate image queries to address technical issues, track those issues and ensure timely resolution
• Clinical site and imaging center support
• Creation and review of imaging site questionnaires
• Develop training materials for imaging site personnel
• Technical training of imaging site personnel (on-site or telecon)
• Assist in the writing of site imaging manuals
• Contribute to trial specific imaging charters as needed
• Mentor and assist in the training of internal staff
• Other duties as assigned by manager
EDUCATION AND EXPERIENCE
• Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred.
• Minimum of 2 years of experience in medical imaging required
• Proficiency in MS Office and internet applications required
• Minimum of 1 year of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of image trial documents strongly preferred; i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.
• Prior Project Management duties preferred, i.e. driving timelines, deliverables and managing concurrent priorities
SKILLS
• Service oriented approach, flexible and proactive
• Must have superior attention to detail and excellent oral and written communication skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Must have the ability to work under pressure with multiple competing priorities
• Must have strong time management, and organizational skills.
• Prioritizing workload to the changing needs of the day to day business is also a critical skill.
• Ability to work in strict compliance with all procedures, rules and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Project Management Skills preferred
• Ability develop and drive project timelines
• Ability to motivate others and keep project teams working effectively
• The ability to communicate clearly, concisely and frequently and know when to use email, schedule meetings or conduct one-on-one conversations
• Possess the skills required to keep senior leadership informed to support business making decisions
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
TRAVEL
Up to 10-15%% both domestic and international Show more details...
Imaging Endpoints (IE) is an Imaging Clinical Research Organization (iCRO) that also provides comprehensive CRO and Site Management Organization (SMO) services for image-centric trials. We are...
based in Scottsdale, Arizona and are an affiliate of the Scottsdale Healthcare Network, one of the 50 largest healthcare systems nationally, and an affiliate of Scottsdale Medical Imaging Limited (SMIL), ranked as the 4th largest private radiology group in the US. Our experience extends from translational to phase III and IV studies and every step in between.
The Imaging Specialist is primarily responsible for conducting a variety of QC/analysis procedures. This person is responsible for reviewing the imaging data received from clinical trial imaging sites/sponsors to confirm specific protocol requirements have been met as well as ensuring technical adequacy and data integrity. In additional this person will assist in project management duties within the operations department and serve as imaging technical support for internal and external staff.
RESPONSIBILITIES
• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Perform Imaging data reconstruction per trial specifications
• Manage research projects and early phase clinical trials for day-day activities
• Compel quality control documentation according to standard operating procedures
• Develop quality control documentation in conjunction with the Project Manager
• Generate image queries to address technical issues, track those issues and ensure timely resolution
• Clinical site and imaging center support
• Creation and review of imaging site questionnaires
• Develop training materials for imaging site personnel
• Technical training of imaging site personnel (on-site or telecon)
• Assist in the writing of site imaging manuals
• Contribute to trial specific imaging charters as needed
• Mentor and assist in the training of internal staff
• Other duties as assigned by manager
EDUCATION AND EXPERIENCE
• Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred.
• Minimum of 2 years of experience in medical imaging required
• Proficiency in MS Office and internet applications required
• Minimum of 1 year of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of image trial documents strongly preferred; i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.
• Prior Project Management duties preferred, i.e. driving timelines, deliverables and managing concurrent priorities
SKILLS
• Service oriented approach, flexible and proactive
• Must have superior attention to detail and excellent oral and written communication skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Must have the ability to work under pressure with multiple competing priorities
• Must have strong time management, and organizational skills.
• Prioritizing workload to the changing needs of the day to day business is also a critical skill.
• Ability to work in strict compliance with all procedures, rules and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Project Management Skills preferred
• Ability develop and drive project timelines
• Ability to motivate others and keep project teams working effectively
• The ability to communicate clearly, concisely and frequently and know when to use email, schedule meetings or conduct one-on-one conversations
• Possess the skills required to keep senior leadership informed to support business making decisions
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
TRAVEL
Up to 10-15%% both domestic and international Show more details...
via Glassdoor
posted_at: 22 days agoschedule_type: Full-time
SUMMARY
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most... impactful new drug approvals in oncology, and we
SUMMARY
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most... impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.
Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.
The Imaging Project Manager is responsible for working with sponsors to manage timelines, deliverables and resources, liaise with the appropriate staff to complete work as detailed in the client’s contract and/or work order, and to effectively communicate project status and risks with all internal and external stakeholders.
RESPONSIBILITIES
• Execute project deliverables for imaging studies in clinical trials in accordance with project scope of work and within sponsor specified timelines;
• Manage day-to-day operational aspects of a clinical imaging projects.
• Assist in preparation and adherence to imaging trial documents i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc;
• Ensure project documents are complete, current, and stored appropriately;
• Manage key project documents/processes, i.e. Project Management Plan, Communication Plan, Escalation Plan, Risk Management Plan and appropriate Clinical Trial Management System (CTMS);
• Identify resources needed and assign individual responsibilities;
• Identify out of scope requests and work with appropriate team(s) to revise the work order to meet changing needs and requirements;
• Review and manage all deliverables;
• Prepare metrics reporting for client and senior management;
• Prepare forecasting information for Finance purposes;
• Perform other duties as assigned by the Supervisor
EDUCATION AND EXPERIENCE
• Bachelor’s degree or equivalent certification in a health related field
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is required
• Knowledge of key project management documents and tools a must
• Prior experience with different EDC systems required
• Proficiency in MS Office and internet applications required
• Minimum of 3 to 5 years of experience in the clinical trials industry required
• Minimum of 2 years of experience in medical imaging in a clinical trial environment required
• Experience managing global Phase III clinical trials with imaging components strongly preferred
• PMP certification a plus
SKILLS
• Service oriented approach, flexible and proactive towards adapting to sponsors’ needs
• Ability to manage project activities with diverse groups and individuals
• Must have superior attention to detail and excellent oral and written communication skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Must have the ability to work under pressure with multiple competing priorities
• Must have strong time management, and organizational skills. Prioritizing workload to the changing needs of the day to day business is also a critical skill.
• Ability to work in strict compliance with all procedures, rules and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Possess the ability to understand research projects and successfully lead within the clinical trial environment
IMAGING ENDPOINTS’ TEAM CHARACTERISTICS
• Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves – see more information about Caring Endpoints at https://imagingendpoints.com/caring-endpoints/
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
Travel: Travel up to 20% (Domestic and International Show more details...
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most... impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.
Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.
The Imaging Project Manager is responsible for working with sponsors to manage timelines, deliverables and resources, liaise with the appropriate staff to complete work as detailed in the client’s contract and/or work order, and to effectively communicate project status and risks with all internal and external stakeholders.
RESPONSIBILITIES
• Execute project deliverables for imaging studies in clinical trials in accordance with project scope of work and within sponsor specified timelines;
• Manage day-to-day operational aspects of a clinical imaging projects.
• Assist in preparation and adherence to imaging trial documents i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc;
• Ensure project documents are complete, current, and stored appropriately;
• Manage key project documents/processes, i.e. Project Management Plan, Communication Plan, Escalation Plan, Risk Management Plan and appropriate Clinical Trial Management System (CTMS);
• Identify resources needed and assign individual responsibilities;
• Identify out of scope requests and work with appropriate team(s) to revise the work order to meet changing needs and requirements;
• Review and manage all deliverables;
• Prepare metrics reporting for client and senior management;
• Prepare forecasting information for Finance purposes;
• Perform other duties as assigned by the Supervisor
EDUCATION AND EXPERIENCE
• Bachelor’s degree or equivalent certification in a health related field
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is required
• Knowledge of key project management documents and tools a must
• Prior experience with different EDC systems required
• Proficiency in MS Office and internet applications required
• Minimum of 3 to 5 years of experience in the clinical trials industry required
• Minimum of 2 years of experience in medical imaging in a clinical trial environment required
• Experience managing global Phase III clinical trials with imaging components strongly preferred
• PMP certification a plus
SKILLS
• Service oriented approach, flexible and proactive towards adapting to sponsors’ needs
• Ability to manage project activities with diverse groups and individuals
• Must have superior attention to detail and excellent oral and written communication skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Must have the ability to work under pressure with multiple competing priorities
• Must have strong time management, and organizational skills. Prioritizing workload to the changing needs of the day to day business is also a critical skill.
• Ability to work in strict compliance with all procedures, rules and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Possess the ability to understand research projects and successfully lead within the clinical trial environment
IMAGING ENDPOINTS’ TEAM CHARACTERISTICS
• Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves – see more information about Caring Endpoints at https://imagingendpoints.com/caring-endpoints/
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
Travel: Travel up to 20% (Domestic and International Show more details...
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