Principal Investigator Drug Product Technologies jobs at Incyte in United States, Wilmington

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.

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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.

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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)

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 .

Job Summary (Primary function)
This position will be mainly responsible for performing high resolution LC-MS analysis to characterize novel therapeutic monoclonal antibodies including bispecifics which are used for clinical studies and commercial launch. This is a hand-on position and requires solid scientific knowledge of LCMS for protein characterization and working experience with different high-resolution mass spectrometry platforms (Q-Tof and/or Orbitrap). Strong interpersonal and communication skills are required.

Essential Functions of the Job (Key responsibilities)

• Design and perform experiments for therapeutic proteins using high resolution LC-MS (Qtof and/or Orbitrap) including intact/reduced intact protein mass spec, reduced and non-reduced peptide mapping for characterizing protein primary structure, protein post-translational modifications, sequence variant analysis, and disulfide mapping.
• Record experiments in electronic laboratory notebook to ensure complying with our internal quality policy. Operate and maintain bioanalytical instrumentation in compliance with all safety rules and procedures.
• Interpret LCMS data and generate summary reports to support cell line development, process and formulation development, and comparability studies. Write detail technical reports of protein characterization and elucidation to support novel therapeutic monoclonal antibodies research and development.
• Monitor lab instrument performance weekly, track and order lab supplies when needed.
• Present data summaries and study conclusions at internal scientific meetings.

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

• Expertise with protein mass spec especially mAb PTM characterization by LCMS is a must.
• Ph.D. in chemistry or related fields some relevant experience; Masters’ degree with 3-5 years relevant experience; or Bachelors’ degree in Biopharmaceuticals with >6 years’ relevant experience.
• Working experience with Qtof instruments and/or Thermo Orbitrap is a plus.
• Critical thinking, strong written and verbal communication and organization skills are required.
• Willingness to work independently while collaborating with different functional groups is essential.
• Self-motivated with desire to learn new skills and highly organized with ability to work on multiple projects simultaneously.

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)

Key Responsibilities

Strategic Leadership:

·Collaborate with Executive Director IAI and Global Product Team to refine clinical development and commercialization strategies.

·Evaluate and advance innovative formulations, combination products, and delivery mechanisms for dermatology.

·Guide late-stage assets through pipeline development.

·Drive global launch strategies with GPS, integrating diverse perspectives.

Commercialization Optimization:

·Develop annual commercialization plans that guide country-specific brand strategies.

·Identify market insights to refine product differentiation.

·Partner with clinical and medical affairs on data generation and evidence planning

·Work closely with the Regions and cross functional partners to create scientific narrative and shape publications strategy

·Co-lead the creation of global forecast and long range strategic plan

·Lead the Global Commercialization Team.

·Work with local markets and multiple departments (Medical Affairs, Competitive Intelligence, Regulatory, etc.) to align global marketing strategies.

·Support formulation development and competitive analysis.

·Develop business cases for new opportunities.

·Align global strategies through regular regional forums.

·Guide regional decision-making, including ATU analysis and market-specific strategies.

Innovation & Growth Initiatives:

·Drive impactful commercial initiatives aligned with strategic imperatives.

·Ensure seamless execution of innovation projects.

Qualifications

·Bachelor's degree required; advanced science, medical, or business degree preferred.

·Extensive experience in biotech/pharma commercial operations, including strategy, brand leadership, and launches.

·Experience in lifecycle and portfolio management

·Background in immunology/autoimmunity, preferably dermatology, with strategic leadership experience.

·Strong ability to lead cross-functional teams, influence business direction, and challenge status quo.

·Competitive mindset with strong analytical skills for data-driven decision-making.

·Familiarity with global drug development and approval processes.

·Experience working in diverse environments; internation experience is a plus but not required

·Exceptional communication skills and adaptability in fast-changing environments.

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 .

We are seeking a highly motivated and experienced crystallographer to join our structural biology team within the Protein Science and Technology department. The successful candidate will help accelerate gene-to-structure workflows and will play a pivotal role integrating Protein Engineering, Crystallography and AI to support small molecule and biologics drug discovery. The position requires great wet lab skills, and a team-oriented approach to characterize protein samples and/or complexes and deliver high-quality co-crystal structures. In addition, the candidate will be involved in the management of a state-of-the-art Crystallography laboratory and external collaborations to support a diverse portfolio of projects.

• Crystallography experience is required. Cryo-EM experience is desirable, but not required.
• Requires good skills on recombinant protein purification, crystallization and structure determination.
• Help troubleshooting recombinant protein expression and purification.
• Protein engineering experience is highly desirable.
• Train, mentor, and supervise a team of scientists, technicians, and support staff.
• Membrane protein experience is highly desirable but not required.
• Knowledge of protein structure prediction and computational approaches for protein design is desirable.
• Stay current on emerging technologies and instrumentation in protein chemistry, biochemistry and structural biology to introduce innovative approaches.
• Troubleshoot and optimize workflows to improve the efficiency and reproducibility of experimental results.

Key Responsibilities:

• Responsible for gene-to-structure experiments. Crystallization, data collection, structure determination and reporting structures.
• Protein Expression: Design and manage strategies for expression of targets.
• Protein Purification: Design, optimize, and execute protocols for the purification of recombinant proteins using various chromatography techniques (e.g., affinity, ion exchange, size exclusion).
• Biophysical Characterization: Perform biophysical characterization of purified proteins samples and complexes including but not limited to analytical SEC, DSF, TSA.
• Data Analysis & Reporting: Maintain detailed records of experimental designs, data, and results. Analyze and interpret data for presentation to key stakeholders.

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

• Ph.D. in chemistry, structural biology, biochemistry or related field with a minimum of 5 years of experience in biotech or large pharmaceutical company, or BS/MS with 10 years with equivalent experience.

• Post-doctoral and/or industrial experience supporting drug discovery programs using structural biology is desirable.

• Good communication and interpersonal skills.

• Proven experience working with matrix teams and leadership skills are highly desirable.

• Self-driven, creative and entrepreneurial with ability to support multiple programs simultaneously.

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 .