Sr Research Investigator Structural Biology jobs at Incyte in United States, 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)
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)

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 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 .

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 .

Job Summary (Primary Function)

We welcome applicants from diverse clinical and scientific backgrounds including M.D., Pharm.D., Ph.D., Nurse Practitioner (NP), and Physician Assistant (PA) professionals who bring deep dermatology expertise and industry-relevant Medical Affairs experience.

Strategic & Scientific Leadership

• Serve as a Medical Affairs lead and subject matter expert in dermatology.
• Develop, track, and report on goals, objectives, and outcomes aligned with organizational strategy.
• Deliver clear and balanced scientific interpretation of clinical and real-world data to both internal and external audiences.

Stakeholder Engagement & External Collaboration

• Build and maintain trust-based relationships with external experts, healthcare professionals, and advocacy groups.
• Represent Medical Affairs at scientific congresses, advisory boards, and investigator meetings, promoting diversity and inclusion in engagement.

Cross-Functional Collaboration

• Partner with Commercial, Clinical Development, Safety, Regulatory, MSLs, and Training to align scientific and strategic initiatives.
• Provide scientific guidance for promotional material review via the Medical-Legal-Regulatory (MLR) Committee.
• Contribute to sales training, speaker development, and field team enablement.

Medical Evidence Generation

• Provide scientific oversight and serve as a medical reviewer or monitor for Investigator-Initiated Research (IIR) and Medical Affairs-led clinical trials or observational studies.
• Collaborate on study design, analysis, and publication strategy for evidence generation initiatives.

Required Education & Credentials (One of the following):

• M.D. or international equivalent
• Pharm.D., Ph.D. in life sciences or related discipline
• Nurse Practitioner (NP) or Physician Assistant (PA) with advanced clinical training and experience in dermatology

Professional Experience

• Minimum 2 years of direct Medical Affairs experience in the pharmaceutical or biotechnology industry, or equivalent in academia/clinical practice with industry-relevant roles
• Clinical or scientific expertise in dermatologic conditions such as atopic dermatitis, hidradenitis suppurativa, vitiligo, or other inflammatory skin diseases. Clinical practice experience in dermatology preferred
• Experience in Medical Affairs strategy, product launch, and evidence generation highly valued
• Experience with clinical trials, IIRs, and medical monitoring is preferred

Skills & Core Competencies

• Ability to communicate complex medical/scientific concepts effectively across audiences
• Strong understanding of clinical data analysis, translational medicine, and real-world evidence
• Demonstrated commitment to collaboration, diversity, inclusion, and teamwork
• Ability to educate, coach, and mentor internal teams and engage meaningfully with external 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 .