דרושים ב-Incyte ב-United States, Delaware, Wilmington

Job Summary (Primary function)
The Sr. Biologics CMC (Chemistry, Manufacturing, and Controls) Writer will be primarily responsible for authoring CMC sections of global regulatory submissions including BLA, IND, IMPD, MAA as well as working with other technical documents (e.g.. Redlining/SOC reports). The position will manage work independently with members of the Biologics Pharmaceutical Development group as well as other functional areas within the organization, including external collaborators, to complete the full package ready for submission.

Essential Functions of the Job (Key responsibilities)

• Contribute to the phase appropriate development strategy for the Biologics portfolio.
• Write and edit CMC sections of Regulatory documents that are submitted to Regulatory Agencies worldwide. Experience with authoring Module 3 CTD sections for IND and BLA is highly desirable.
• Collaborate with subject matter experts to write and edit other manufacturing related controlled technical documents using a uniform style and language for regulatory compliance.
• Coordinate authoring and review activities with the functional areas within Global Biopharmaceutical Development and Quality Assurance to reach alignment and to meet deadlines for Regulatory Submissions.
• Work closely with Regulatory Affairs to establish priorities and ensure successful completion of regulatory submissions to Regulatory Operations.

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

• Degree (such as BS/MS/PhD) in Engineering or Biological Sciences or equivalent experience and in the biotech related industry.
• Several years of experience in Biologics technical writing as a SME in Analytical, Formulation, or Process Sciences, in authoring CMC sections of global regulatory filings.
• Technical knowledge of and experience in monoclonal antibody development is a plus.
• Experience with working collaboratively with other departments such as technical teams, Quality Assurance and Regulatory Affairs.
• Proven track record on regulatory submissions of biological products.
• Demonstrate competency in clear and concise technical writing ability.
• Must be well organized, flexible, with excellent cross-functional communication skills that encourages inclusion and welcomes diversity of thought among stakeholders.

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 Principal Biostatistician is responsible for providing statistical support for drug development programs in all phases of development.

Essential Functions of the Job (Key responsibilities)

• Participate in the development and enforcement of SOPs and guidelines.
• Participate in pre-IND and NDA activities.
• Participate and contribute to authoring of Clinical Development Plan.
• Assist in writing relevant sections of the clinical study report.
• Interpret study results and provide review of statistical summary reports of study results for accuracy.
• Provide guidance and support to team members in creating analysis dataset specifications and programming of tables, listings, and figures.
• Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
• Write statistical analysis plans.
• Interact with members of the multidisciplinary project teams to establish project timelines. Provide statistical input to study protocols.

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

• Familiarity with multivariate analyses and biomarker analyses is beneficial.
• Experience in collaborating with health authorities, including discussions and negotiations in filing strategies, is highly desirable.
• Proficiency in using SAS to perform efficacy analyses and validate important data derivations when necessary.
• Able to effectively communicate their ideas and to manage team members in a constructive manner.
• Demonstrate ability to work independently and collaboratively in project management and decision making.
• Experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics is preferred, but not required. We welcome candidates with diverse backgrounds and experiences.
• Advanced degree in statistics or equivalent experience 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)

The Biostatistical Programmer to Principal Biostatistical Programmer is responsible for processing clinical data required for statistical analysis of Phase I — III clinical trials and leading project teams.

Essential Functions of the Job (Key responsibilities)

• Conduct statistical programming work of clinical data using SAS Software.
• Ensure that all programs, outputs and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs.
• Generate analysis datasets according to CDISC standard and SAP.
• Implement analysis methods according to SAP, and produce summary tables, graphs and data listings using SAS; Conduct ad hoc analyses.
• Validate programs and associated results produced by other programming team members
• Participate in TLF shell preparation and review, and assist statistician for SAP preparation.
• Run CDISC validation programs e.g. OpenCDISC reports to ensure ADaM datasets are CDISC compliant.
• Develop standard SAS macros for efficient analyses of clinical data under the guidance of Programming management.
• Participate in the review of 'Statistical Analysis Plan' and other documents essential to the conduct of statistical programming work for clinical trials.
• Collaborate with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, timelines, and deliverables are met. Work independently to program for individual studies with minimal supervision.
• Work independently to program for individual studies with minimum supervision.
• Function as a Lead programmer for a project or a group of studies performing the following functions:
  • Maintain the overall timeline for their studies.
  • Maintain the programming standards for their studies.
  • Review standard macros used.
  • Review standard datasets used.
  • Discuss the need for programming resources for the group of studies.
  • Guide and support team members on Incyte systems and standards as they work on studies within their area.
  • Assist less experienced programmers in new study set-up to help identify similar studies.
  • Review Production area after study programming is complete to make sure datasets, programs, and outputs are properly stored.
  • Check that the validation summary reports are clean of errors and warnings, and show proper documentation of SAS programs.
  • Review individual study CDISC validation output.
• Act as a Programming lead for a submission project under supervision of Programming management.
• Serve as a mentor to less experienced programmers and as an expert to provide recommendations and solutions to complex problems.

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

• Discover – Develop – Deliver – Collaborate
• Strong organizational, time management, communication and project coordination and leadership skills.
• Demonstrate knowledge of regulatory guidelines, including electronic submission standards.
• Good SAS programming skills and attention to detail are essential.
• Experience with data management, including familiarity with CDISC standards, is highly desirable.
• Minimum of several years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries, or equivalent skills and knowledge.
• A degree in a relevant field such as statistics or computer sciences is preferred, but equivalent practical experience will also be considered.
• Demonstrate experience in mentoring team members and providing expert recommendations and solutions to complex problems.
• Must be able to manage multiple tasks while collaborating with team members effectively.
• Must be able to effectively manage workload and prioritize tasks in a dynamic environment.

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)

The Assoc Dir, Biostatistics is responsible for providing statistical support to drug development programs.

Essential Functions of the Job (Key responsibilities)

• Participate in the development and enforcement of SOPs and guidelines.
• Participate in regulatory activities such as health authority meetings and submission related activities.
• Participate and contribute to authoring of Clinical Development Plan.
• Assist in writing relevant sections of the clinical study report.
• Interpret study results and provide review of statistical summary reports of study results for accuracy.
• Provide guidance and supervision to team members in authoring of analysis dataset specifications and programming of tables, listings, and figures.
• Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
• Write and review statistical analysis plans.
• Provide statistical input to study protocols.
• Interact with members of the multidisciplinary project teams to establish project timelines.
• Manage and develop a diverse team of statisticians.
• Provide strategic input to drug development and the development of the biometrics department.
• Serve as a member of the biometrics management team, to manage and support drug development in Incyte.

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

• Ph.D. degree in statistics with 7-9 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process. Experience in oncology drug development, from Phase I to Phase III.
• Demonstrated ability to work independently in project management and decision making.
• Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
• Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.

• Previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable.
• Knowledge of multivariate analyses and Biomarker analyses is a plus.

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 Responsibilities:

• Serve as a DMPK project lead on discovery project teams. Initiate and engage in multifunctional collaborations to facilitate the advancement of drug candidates and build thorough knowledge of drug candidate properties.
• Responsible for the design and interpretation of preclinical DMPK studies necessary for the selection of clinical candidates.
• Ensure adequate characterization and liability assessment to support candidate nomination and clinical dose projections.
• Responsible for writing PK reports, and author DMPK sections for regulatory submissions and IB updates.
• Develop interdisciplinary collaborations and ensure that key DMPK data, information, and priorities are integrated into overall project team strategy.

Minimum Requirements

• PhD or equivalent with 5+ years of industry experience in PK.
• Strong working knowledge of ADME (in vitro, in vivo, in vitro-to-in vivo) and pharmacokinetics with hands-on experience using PK software tools (e.g., WinNonlin, Gastroplus) is required. Knowledge and expertise in modeling such as PBPK and PK/PD is preferred.
• Experience as a DMPK project lead in discovery programs is preferred.
• PK knowledge and experience with biologics and protein degraders is a desirable plus.
• Appropriate understanding of applicable FDA and European regulations with experience in IND filing and clinical protocols is a plus
• Excellent oral and written communication skills are essential along with strong organizational skills.

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 .