דרושים Associate Vice President Financial Planning & Analysis ב-Incyte ב-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.

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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 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 Summary

In addition to core responsibilities, the role may support labeling process optimization initiatives aimed at enhancing efficiency and quality. Collaboration with external partners may also be required. The ideal candidate is adaptable and capable of making sound decisions in a dynamic, complex environment.

Key responsibilities

• Lead cross-functional teams in the development, revision, review, and approval of CCDS and local labeling documents in compliance with regulatory and internal standards.
• Author new and/or revised CCDS, USPI and EU SmPC for assigned products, obtaining input and approval from all relevant functional areas.
• Conduct research on labeling precedent, regulatory policies, and health authority requests, to advise on potential labeling impact, strategy, or outcome.
• Provide strategic input for Health Authority interactions related to labeling, including submissions, responses to questions, and negotiations.
• Manages process for alignment of local labeling with CCDS/reference label, including assessment of labeling deviations.
• Support local affiliates in responding to health authorities queries and reviewing local labeling differences.
• Act as the GRA Labeling point of contact on Global Regulatory Team to ensure timely delivery of compliant, high-quality labeling documents.
• In collaboration with Supply Chain, contribute to the development of new and updated packaging mock-ups and artwork for regulatory submissions.
• Support Health Authority inspections by providing labeling documentation and process overviews.
• Oversight and accountability for external vendors managing labeling activities, ensuring quality, timeliness, and compliance.
• Actively contributes to improvement of labeling processes to enhance agility, efficiency, and accuracy.
• Represent GRA Labeling in departmental and cross-functional initiatives and taskforces.

Qualifications

• Bachelor’s degree in a scientific discipline. Advanced degree (MS, PharmD, PhD) preferred.
• Relevant experience in the pharmaceutical industry including 5+ years of direct experience in Regulatory Labeling.
• Experience that demonstrates ability to develop labeling documents (e.g., initial CCDS).
• Ability to guide cross-functional teams and drive consensus to address labeling issues.
• Ability to assimilate clinical and scientific information and distil important aspects for impact to labeling. Understanding of medical concepts and terminology.
• Strong project management skills to plan, prioritize, lead, and execute individual work, and teamwork related to regulatory labeling.
• In-depth and practical knowledge of labeling requirements globally (US and EU required), including development and life-cycle management of local labeling documents.
• Experience with document management systems (Veeva 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
The Associate Director, Regulatory Affairs works in collaboration with the Director, Regulatory Affairs to develop strategy and ensure regulatory requirements for assigned products are complete. The Associate Director is also responsible for day-to-day coordination and preparation of regulatory submissions and will work and interact with internal cross-functional team members in order to create regulatory submission documents that are compliant with US FDA and/or global regulatory requirements. The Associate Director will collaborate with the Director, Regulatory Affairs to lead meetings with FDA and other Health Authorities.

Essential Functions of the Job (Key responsibilities)

• Manage the creation, review, and submission of regulatory documents (new protocols, new investigators, adverse events, periodic and annual reports, Development Safety Update Reports, nonclinical and clinical study reports, summary documents etc.) to support product development, clinical trials, and marketing applications in the US, EU, Canada, and rest of world as applicable.
• Review regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards.
• Ability to read and understand all components of a regulatory submission (IND, CTA, NDA, MAA, etc.) to ensure consistency across documents.
• Ensure that dossiers containing technical, nonclinical, and clinical data are presented clearly and succinctly to optimize the regulatory review and approval process.
• Ensure regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.
• Coordinate the preparation of responses to questions and inquiries from health authorities.
• Liaise with FDA and other health authorities as needed (e.g. telephone contacts, teleconferences, meetings, submissions).
• Ensures accurate retention in the archival system of all regulatory submissions and contacts with health authorities.
• Maintain current knowledge of relevant US and international guidance’s, laws and regulations, and proposed and final rules which affect pharmaceutical drug development and companion diagnostics.
• Provide regulatory guidance to departments and/or development project teams regarding the documentation and requirements for regulatory submissions.
• Keep employees informed of relevant regulatory guidance documents, regulations and information.
• Strong communication skills; both oral and written.
• Strong interpersonal skills with the ability to influence others in a positive and effective manner.
• Demonstrated ability to contribute to a continuous learning and process improvement environment.
• Strong analytical and organizational skills and ability to support multiple projects in a timeline-driven environment.
• Experience with document management systems, eCTD submissions managing, and maintaining regulatory files preferred.

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

• Bachelor’s or advanced degree (e.g., Ph.D., Pharm.D.). Scientific/life-sciences degree a plus. Regulatory Affairs (RAC) Certification is a plus.
• A minimum of 3 years direct responsibility for regulatory affairs with at least 5 or more years of drug development experience.
• In-depth knowledge of regulations/guidelines governing development of pharmaceuticals; experience working with international regulatory agencies.
  

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)

Reports to Assoc. Vice President, Contracts and Governance; regarding the Contract Lifecycle Management (CLM) system. This position is responsible for projects that help drive efficiency and improve Legal department processes. May work with internal and external clients. Ensures that goals are accomplished and in line with objectives and against timelines. Helps to monitor activities of IT ensuring quality and integrity in relation to CLM. Comfortable making decisions, as appropriate, and knows when to escalate. Willingness to grow and take on additional responsibilities as it relates to Legal technologies or systems.

Essential Functions of the Job (Key responsibilities)

·Governance and Maintenance of all Templates and Clause Library configured into CLM

·Govern and maintain contract templates

·Collaborate with Legal Counsel and other relevant functional area stakeholders, as it relates to contract terms and templates

·Identify opportunities for and/or establish, vet and document fallback language and options with guidance/drafting notes

·Build and maintain clause library based on risks, standards, and fallbacks developed

·Establishment and Maintenance of a Document Repository

Identify, implement and maintain a document repository by working with Legal and IT

Governance for 3rd Party Risk Accountability & Engagement Pre-contract and Contracting Playbook(s)

Assist with development of and, ongoing management and governance of pre-contracting and contracting processes.

Facilitate and organize meetings among global stakeholders.

Assist in the development, maintenance, delivery and implementation of training related to pre-contracting and CLM processes and systems along with IT, Global Strategic Sourcing, and other relevant stakeholders.

·Contract Resource Center of Excellence

Build and/or provide guidance to contract negotiators located in Legal, Global Strategic Sourcing, and certain functional areas including but not limited to Development Operations and US Medical Affairs.

·Records Retention

Work with Legal and Compliance to help refine, develop, document, govern, maintain and implement records retention schedule, in relation to CLM

·Relationships

·CLM Maintenance

Assist with contract system configuration by working with IT and consultants as applicable; learn and develop CLM configuration skills

Perform testing in CLM, as may be required

Drive or assist with communications related to system changes or updates

Manage day-to-day overall database administration

·Training

For all assigned duties, assist with the development and delivery of training materials for staff globally

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

·Bachelor’s degree or equivalent relevant experience

·Significant relevant experience (typically 8-10+ years), or equivalent combination of education and experience

·Legal background, J.D. or Paralegal Certification preferred, or equivalent relevant experience

·Experience in the pharmaceutical industry or a related field preferred

·Knowledge of, or willingness to learn, SOX requirements, controls, and processes

·Familiarity with DocuSign, or willingness to learn

·Familiarity with Conga (Salesforce platform) helpful but not required

·Familiarity with Agiloft CLM and AI functionality helpful but not required

·Familiarity with ZIPHq helpful but not required

·Ability to draft legal language

·Ability to navigate CLMs or other Compliance/Operational Technologies

·Demonstrate interpersonal, communication and organizational skills

·Ability to effectively communicate and comfortable working across functional areas and with a wide range of audiences, including from individual contributor and executives

·Ability to take direction and work independently

·Ability to design or test new processes, capabilities, and technologies

·Ability to suggest ideas and present; ability to analyze and document current processes and establish new processes

·Ability to design or test new processes, capabilities, and technologies

·Self-motivated, able to work collaboratively, organized, and detail-oriented

·Demonstrates dependable time management skills and ability to make decisions

·Positive and constructive attitude

·Ability to manage multiple projects and tasks

·Ability to adapt to new challenges and changes in direction

·Ability to learn, follow and help further define or establish processes

·Ability to work with a variety of variables

·Ability to interpret a variety of instructions furnished in written, oral, hands-on, or diagram form

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 .

Duties and Responsibilities

• Deliver therapeutic information on products in line with marketing strategy
• Promote INCYTE IAI Dermatology product to prescribing Dermatologist specialists in compliance within compliance and legal requirements and according to the marketing and sales strategies defined by the product line
• Create formal networks with key decision makers within the assigned territory and with important local players; use these contacts appropriately to develop district business within compliance and legal requirements and company policy
• Market surveillance – gain and share customer insights
• Perform local marketing, sales analyses and gain patient flow insights
• Organize and conduct regional promotional meetings for physicians and other stakeholders
• Management of professional relations with Opinion leaders
• Develop and execute customer and account business plans, within designated key accounts, to ensure that all appropriate patients have access to INCYTE Pharmaceuticals medicines
• Understand and map the local and regional funding, clinical and access decision processes and identify all key stakeholders
• Ensure a favourable local access environment to maximise the potential for sales, and to drive sales growth to realise this potential
• Documentation and reporting of daily activities, routine administration, finances etc
• Participation at congresses, meetings and physician trainings
• Excellent team player with proven ability to work cross-functionally and coordinate effectively with key internal stakeholders
• Curiosity and lifelong learning – Constantly update commercial knowledge and disruptive strategies.
• Creative thinking – Find innovative solutions for barriers and challenges.
• Manage and own personal development plan
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines

Requirements

• Life Sciences Degree or equivalent professional qualification
• More than 5 years of experience in promoting specialist pharmaceutical products – preferably in Dermatologist
• Demonstrated track record of Specialist sales
• Experience or understanding of Market Access and the NHS environment is a plus
• Good team player
• Very strong communication and presentation skills
• Professional appearance
• Self-motivated entrepreneurial mindset
• Good IT-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)
The Assoc Dir, Clinical Research Scientist is responsible for working with the physicians within Clinical to provide clinical research support for programs as assigned by phase or therapeutic area.

Essential Functions of the Job (Key responsibilities)

• Development of protocols for clinical studies.
• Preparation of clinical development plans.
• Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other FDA submissions.
• Monitor, review and summarize safety and efficacy data in ongoing studies.
• Assist with study design for exploratory development.
• Will lead the clinical matrix teams for assigned compounds.
• Represent exploratory development on project teams.
• Develop relationships with appropriate consultants.
• Write abstracts and present data at scientific meetings, both internally and externally.
• Serve as liaison to project teams, CRO's and others.

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

• Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred.
• Minimum of 2 - 4 years of experience in research with at least 1 or more years of drug development experience are required.
• Prior Oncology Drug Development experience a plus.
• Ability to multi-task and work in a fast-paced environment.
• Excellent written and oral communication skills.
• Strong Analytical ability.

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 .