Sr Director Clinical Research Scientist Iai jobs at Incyte in United States, Wilmington

Director, PMO (Project Management Office) Capacity Management Leadoperations, financial processes, and resource management concepts.This role will provide support and guidance to key R&D partners on capacity management systems, tools, data, and processes. You will lead the design, and support the development and delivery, of various activity-based models within our Planisware system.

Key Responsibilities

• Clinical Cost Modeling: Lead the creation of robust cost models for clinical trials, factoring in variables such as patient recruitment, site management, drug supply, and regulatory requirements. Refine cost models for clinical trials, incorporating financial assumptions and benchmarks.
• Activity-Based Forecasting: Oversee the development of forecasts for clinical trial activities, incorporating timelines, resource demands, and project milestones to guide R&D planning. Direct the calculation of estimate to complete (ETC) while leveraging remaining timeline assumptions to ensure accurate projections and forecasts.
• Planisware Algorithm Oversight: Manage and validate Planisware algorithm models for financial forecasting, ensuring transparency in inputs (e.g., cost drivers, trial milestones), calculations (e.g., cost allocation formulas), and assumptions. Maintain clear documentation and reporting of Planisware algorithm inputs, calculations, and assumptions to support auditability and stakeholder confidence.
• Strat Plan, Budget, and Forecasts: Support annual budgeting and forecasting processes with workforce related financial insights. Support the alignment of financial and resource data with project and study assumptions for the annual Strategic Planning and Budget Processes. Provide information necessary to support quarterly Forecast and Monthly Planning and Control Processes.
• Orphan Drug Credits: Oversee the tracking and optimization of tax credits and incentives for orphan drug development, maximizing financial benefits
• Business Analysis and Reporting: Prepare and deliver recurring and ad-hoc financial reports to finance leadership and business partners. Provide actionable financial insights through variance analysis, cost-benefit analysis, scenario planning, and other reporting solutions. Translate complex financial/resource management data into clear, actionable insights for both finance and non-finance audiences. Analyze headcount, labor cost, and utilization data to support resource planning
• Cross-Functional Collaboration: Partner with Finance (FPA), clinical operations, regulatory, and development project management teams to ensure forecasting aligns with trial milestones and operational needs. Collaborate with the Business Intelligence Resources within the PMO Team to deliver requirements and develop dashboards to manage resource spending and capacity planning.
• Process Improvement and Oversight: Oversee the design, implementation, and standardization of forecasting and budgeting processes, ensuring consistency, efficiency, and compliance with industry best practices. Lead initiatives to identify inefficiencies, streamline workflows, and implement process enhancements to improve forecasting accuracy and budgeting effectiveness.

Additional Responsibilities

• Advanced Analytics and Forecasting Innovation

Investigate alternative design approaches for forecasting and capacity management, ensuring scalability, flexibility, and alignment with organizational goals. Lead discussions on system transitions, model redesigns, and the incorporation of advanced analytics to support long-term strategic objectives.

Qualifications

Bachelor’s degree in Finance, Accounting, Business Administration, Life Sciences, or a related field (MBA, CPA, or advanced degree preferred)

10+ years of experience in financial planning, forecasting, or budgeting within pharmaceutical R&D or a related industry.

Proven expertise in clinical cost modeling, activity-based forecasting, portfolio management, and process improvement.

Experience with Planisware or similar systems for resource and financial management.

Skills and Competencies:

• Deep understanding of pharmaceutical R&D processes, including clinical trial phases and clinical trial budgeting models.
• Strong analytical and financial modeling skills, with proficiency in advanced analytics and forecasting algorithms.
• Experience working with AI-based models for forecasting, including knowledge of machine learning frameworks and data science principles.
• Ability to ensure transparency through documentation of forecasting models, including inputs, calculations, and assumptions.
• Ability to partner with technical and operational teams to drive financial insight while managing multiple priorities
• Strong business acumen with the ability to work independently and manage multiple priorities.
• Understanding of project-based accounting or resource planning principles.
• Excellent leadership, communication, and stakeholder management skills.

Technical Proficiencies:

• Advanced proficiency in Planisware, ERP systems, and financial reporting tools; Proficient in Excel and financial reporting tools; experience with SQL, Power BI, Tableau, or similar platforms preferred.
• Familiarity with financial systems (e.g., Oracle, SAP, Adaptive Insights, Hyperion) and project costing concepts.

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 .

Key Responsibilities

Investigations & Case Management

·Conduct and oversee all U.S. workplace investigations, including harassment, discrimination, retaliation, misconduct, and code of conduct violations.

·Ensure investigations are conducted promptly, thoroughly, and consistently, balancing fairness, compliance, and business needs.

·Partner with Legal and Compliance to address issues with potential legal, regulatory, or reputational implications.

Policy & Guidance

·Interpret and apply company policies, procedures, and employment law to guide managers and HRBPs on complex ER issues.

·Recommend updates to policies to align with best practices and evolving legal requirements.

Partnership & Support

·Serve as a trusted advisor to HR Business Partners and business leaders on employee relations matters.

·Provide coaching and tools to managers on handling performance, conduct, and conflict issues.

Exit Survey & Reporting

·Develop and launch exit survey processes to capture employee feedback at departure.

·Analyze and report exit data, identifying trends and insights to inform retention and culture strategies.

Metrics & Insights

·Track and report on ER case trends, risks, and outcomes to leadership.

·Provide insights that support continuous improvement of workplace culture and compliance.

Qualifications

·Bachelor’s degree in Human Resources, Business, Law, or related field

·8+ years of progressive HR or employee relations experience, including direct responsibility for workplace investigations.

·Deep knowledge of U.S. employment law and compliance requirements.

·Demonstrated ability to manage sensitive, complex issues with discretion, judgment, and integrity.

·Excellent communication and influencing skills with ability to partner across Legal, Compliance, and HR.

·Strong analytical skills; experience with survey design and data reporting 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 Summary (Primary function)

Essential Functions of the Job (Key responsibilities)

Plan and direct the design, development, maintenance and support of systems implementations, upgrades, and ongoing technology operations with third-party solution providers and Development Operations stakeholders.

Coordinate activities with other IT teams as needed to provide seamless service to assigned business area.

Act as the key liaison across all functional areas, including business units, IT, and external vendors.

Work with business leadership in the efficient and cost-effective delivery of strategic systems solutions.

Manage assigned resources appropriately so that project timelines and defined support objectives are met.

Perform technical/business analysis and prepare recommendations and business plans as needed.

Possess broad knowledge of technical and business resources and use them to effectively coordinate team members and external resources.

Create consensus with other functions as to the timing of solution introductions and withdrawals.

Develop and implement solution frameworks, roadmaps, and strategies to ensure successful introductions across the organization.

Oversee the launch of solutions and maximize the positive impact on the organization.

Identify and evaluate new solution opportunities to address unmet internal and external customer needs.

Define, measure, and report appropriate metrics related to operational support of assigned business areas.

Manage direct report IT team (if applicable), including identification and development of staff.

Participate in strategic and budgetary planning processes.

Participate in the pursuit of new solutions and evaluate the applicability of and effectiveness of current solutions.

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

Bachelor’s degree or equivalent business experience.

10 or more years of IT and business / industry work experience.

Must be an IT subject matter expert in the assigned business area.

Experience in pharmaceutical or relevant life sciences environments.

Hands-on experience implementing any of the following industry leading technology platforms/solutions – Veeva Clinical Operations and Oracle Seibel CTMS – or familiarity with clinical Trial feasibility, recruitment and trial execution platforms.

Ability to perform strategic thinking and planning.

History of operational execution excellence, including management of relevant teams.

Effective written and verbal communication skills to a variety of business and technical audiences.

Ability to establish and maintain strong relationships.

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

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)

·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 .