דרושים Clinical Scientist ב-United States, Delaware, Wilmington

Job Summary

The clinical scientist will

Key Responsibilities

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

Essential Functions of the Job (Key responsibilities)

·Assists in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans, and other supporting documents.

·Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information.

·Participate in the feasibility and evaluation of investigative sites; working closing with the Clinical Trial Logistics group.

·Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization.

·Assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retentions plan.

·Plan and organize meetings with team support (eg. investigator/coordinator meetings, DMC, SMC, safety call, etc.).

·Assist in the development of the IP and co-medication strategy (Quantities, labels, depots, tracking, etc.) working closely with other departments.

·Participate in data review and discrepancy resolution.

·Participate in coordinating efforts with internal Pharmacovigilance, and safety group.

·Monitor study-specific timelines and key deliverables; focus on management of all external vendors (e.g Monitoring, Sample management, IVRS, Laboratory, etc).

·Participate as a member of the multi-disciplinary trial(s) team.

·Develop relationships with investigational sites and institutions to enhance conduct of the trial.

·Acts as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.

·Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.

Qualifications (Minimal acceptable level of education, work experience, and competency)

·BS/BA degree or a relevant degree with strong emphasis on science.

·Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience.

·Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.

·Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.

·Prior experience in assisting the conduct and management of multinational clinical trials is preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

Essential Functions of the Job (Key responsibilities)

·Support the Sample Logistics needs of a diverse group of scientists within the Discovery organization through timely order fulfilment and sample delivery. Develop and integrate CM workflows to support new scientific needs, with a preference for simplifying and streamlining CM delivery processes

·Support Mosaic integration, including transfer of sample management protocols (Solubilization, Titration, Cherry picking), plate definitions and plate maps to Mosaic environment, with a goal of reducing complexity and standardization of processes and deliverables. Serve as Mosaic SME

·Facilitate Sample Management support for large molecule discovery, including normalization, storage and Titration. Facilitate large molecule order fulfilment on new and existing hardware in Mosaic environment

·Acts as custodian of compound management laboratory instruments. Responsible for all instrument service-related tasks.

·Assist with all other Sample management related tasks including HTS library management and Assay plate stamping on Echo automated platforms

·Help to develop new and streamlined workflows to CM to support existing and future order fulfilment

Qualifications (Minimal acceptable level of education, work experience, and competency)

·Extensive years of relevant experience in sample management, with a focus on skills and competencies rather than specific years.

·High competency with Mosaic order fulfilment process, template creation, and user training.

·Working knowledge of and Hamilton liquid handlers and tube storage systems

·Degree in chemistry, biochemistry, or related fields, or equivalent experience.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)
This position is responsible for working with the physicians within Clinical Development to co-lead and provide clinical research support for programs as assigned by phase or therapeutic area.

Essential Functions of the Job (Key responsibilities)

• Design and author protocols for clinical studies
• Responsible for providing clinical input into eCRF design, SAP, and TLFs.
• Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends.
• Provide clinical updates on assigned compounds/programs to Sr. management, Project Teams, Joint Project Teams and/or Steering Committees (if appropriate), Clinical sub-teams, internal strategy and governance meetings, eDMC meetings, steering committees, advocacy groups, scientific advisory boards, and publications committees
• Lead or co-lead the ICF risk language across a compound to ensure a consistent approach
• Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans
• Maintain alignment with the asset Global Lead, Operational Asset Lead, and Global Product Strategy Lead
• Lead, co-lead, and contribute to the review of clinical sections of documents such as IND, IND amendments, Investigator Brochures, oncology unique CRFs, Annual Reports and other Health Authority submissions
• Manage relevant issue escalation to resolution, as items arise on Clinical Development Programs
• Coordinate, lead, and provide clinical input on internal and external slide presentations to ensure consistency of content
• Attend and present at various meetings with internal and external stakeholders (eg, investigator meetings, scientific advisory boards, etc)
• Develop relationships with appropriate consultants and External Experts and utilize these relationships to obtain feedback on protocol design and compound strategy
• Clinical lead for abstracts, posters, oral presentations, and manuscripts for assigned compounds
• Contribute or lead process improvement initiatives
• Provide mentoring, leadership, guidance, and clinical science expertise to Incyte personnel to enable proper decision-making
• Maintain updated knowledge of competitive landscape in regards to assets with similar MOA and/or evolving standards of care for indications of interest
• Liaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as needed
• Liaise with key translational medicine leadership on strengthening and implementing a biomarker plan from a clinical point in development studies for a consistent approach as applicable
• Consult when/if asked by Finances and Clinical Operations on the program budget and at times contribute as needed to the planning of trial/program budgets

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Degree in scientific/life-sciences field such as Master's, Pharm.D, or Ph.D/EdD degree preferred or equivalent experience
• Minimum of 10 years of experience in research with at least 6 years of drug development experience are required. Alternative drug development experience will be considered.
• Prior Oncology Drug Development experience required
• Global oncology trial experience and Health Authority experience are highly preferred
• Excellent written and verbal communication skills
• Strong analytical and strategic ability
• Ability to work independently and to multi-task large projects or compounds, ability to change pace and tasks as needed, and to work in a dynamic environment
• Knowledge of good clinical practice, FDA and EMEA/CHMP regulations, and guidelines
• Experience in managing team members is a plus.
• Ability to lead and/or be a proven leader in a line function responsibility, as well as having an ability to influence in a matrix global environment
• Have proven ability to drive decisions and manage in challenging business situations
• Ability to accommodate up to 20% travel or as business dictates

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

The Senior Research Scientist, Toxicology, provides toxicology support to assigned program(s), with functions in necropsy, histology, and clinical pathology.

Essential Functions of the Job (Key responsibilities)

• Performs necropsy of mice and rats, oversees necropsy setup, cutting, and trimming. Assist in managing the necropsy facility. Assists in training team members to perform mice and rat necropsies. Has a working knowledge of the software system (Pathology Data Systems, PDS) used for data collection of macroscopic findings and organ weights. Proficient in using the software to set up studies for data collection.
• Perform Clinical Pathology setup and instrument maintenance according to study requirements. Collect and analyze hematology and clinical chemistry samples using current in-house equipment, ensuring accessibility for all team members. Demonstrate knowledge of analyte ranges, data interpretation, control data, and calibration data. Utilize software (PDS) for the collection and quality control of clinical pathology data, ensuring inclusivity and accessibility in data handling.
• Preparation of histology slides from tissues from both large animal studies (e.g., dog, monkey) in collaboration with CRO's and small animals (e.g., rat, mouse) in-house studies, including trimming, processing, embedding, sectioning, and H&E staining. Assist with quality assessment of the pathology slides. Working knowledge of maintenance of the instrumentation to perform these functions.
• Preparation of immunohistochemically stained tissues sections and organic stained tissue sections on a per study basis.
• Archive gross tissues, tissue cassettes, and slides. This includes the receipt, reading and return of slides from GLP and non-GLP peer review studies.
• Collaborate and support other groups in the method development of animal models. Working knowledge of cell culture preparation, alternative media preparation, and whole blood assays is preferred, but not required.
• Assist in quality assurance of data and reports generated by the pathology group.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Degree in Biology/Medical Technology or a related field, or equivalent education and experience.
• Significant experience in a relevant scientific discipline, with a focus on skills and knowledge over years of experience.
• ASCP HT or other medical technology certification preferred but not required.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .