Vice President Toxicology jobs at Incyte in United States, Wilmington

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.

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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 Associate Vice President, Financial Planning & Analysis supports the planning and managing budgets, forecasting product revenues, and evaluating life cycle management activities.

Essential Functions of the Job (Key responsibilities)

• Develop and maintain revenue long range forecast, margins and sales and marketing expenses.
• Maintain Specialty Pharmacy and Wholesale customer contracts.
• Help departments manage the procurement process, including API.
• Support Accounting as needed (e.g. month end closing, coordinate revenue recognition and reporting, prepare GL, review A/R and inventory entries, etc.).
• Work with VP Finance and Chief Accounting Officer and executive leadership to provide financial leadership, analysis and negotiation in support of business decisions.
• Manage Third Party Government Price Reporting partner.
• Manage Third Party Logistics partner.
• Lead meetings with business partners to review periodic expense updates with the goal of understanding actual vs. budget performance and risk/opportunities to the budget.
• Develop and maintain product P&L, gross to net calculations, customer analysis, margin analysis and geographic analysis.
• Provide daily/weekly/monthly departmental reporting for corporate functions into the VP Finance and Chief Accounting Officer and the CFO.
• Develop and maintain all contract SOPs for Commercial Operations and Contract Manufacturing.
• Develop and maintain 404 SOX controls with the Controller as it relates to Commercial Operations.
• Develop and maintain internal reporting (e.g. product P&L, dashboard, compliance reporting).
• Develop and maintain ERP system for sales force and marketing expense tracking.
• Develop and maintain ERP system for revenue, accounts receivable, HCP payment and disclosure, government programs and accounting, and all other compliance and pricing requirements (with third party vendors as needed).
• Leading the long-range enterprise financial planning, annual budgeting and monthly forecasting processes to ensure accurate and timely projections for executive leadership, operational management and the board of directors.
• Provides day to day leadership, performance management, coaching and mentoring to direct reports.

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

• Discover – Develop – Deliver – Collaborate.
• Financial planning & analysis, third party payer and pharmaceutical compliance reporting.
• 15+ years experience with financial analysis and reporting of inline pharmaceutical or biotech products.
• MBA in Finance or equivalent.
• Results driven, reliable and excellent problem solving and analytical skills.
• Must have a strong track record or recruiting/developing talent.
• Exceptional communication (written and oral) and presentation skills.
• Oracle and Hyperion Planning an asset.
• Highly motivated, self-directed and have the ability and desire to have real impact on an organization.
• Inquisitive and innovative in his/her approach to inorganic growth, mergers and acquisitions, function enablement and support for high growth and value creation.
• Experience building and/or operating a best-in-class FP&A function.
• Must be operationally-oriented with a keen focus on process, metrics, and results.
• Strong executive presence and be comfortable and credible interfacing within executive leadership, the board of directors, and private-equity investors.
• Prior experience creating and managing financial organizations in Biotech or Specialty Pharma preferred.
• knowledge.

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 Vice President, Toxicology oversees and manages the toxicology function within Discovery Biology in support of the organization’s goals and mission. The VP manages all activities associated with safety evaluation of small and large molecule new chemical entities, lead risk mitigation strategies, support of worldwide regulatory filings and effective communication across functions within the organization.

Essential Functions of the Job (Key responsibilities)

• Work with toxicology project leads to define toxicology program strategies and timing for all discovery and development projects (small and large molecule), including general toxicology, developmental and reproductive toxicology, genetic toxicology, carcinogenicity and safety pharmacology. Ensure programs align with current global regulatory requirements and industry standards.
• Evaluation of the risk associated with toxicology/safety signals (earliest possible time) and the effective communication of the impact of the safety signal to the organization. Development and implementation of strategies to mitigate/resolve risk associated with toxicology safety signals.
• Active and proactive participation at the senior level of scientific, strategic, and operational aspects of drug discovery and development within the pharmacology, toxicology, and both early and late stage clinical drug development process.
• Oversight of the writing, review and evaluation of documents for FDA and global submissions. Manage support of regulatory filings with worldwide regulatory authorities from IND/CTA through NDA/BLA/MAA.
• Communication (written and oral) with regulatory agencies in response to questions arising from regulatory submissions; review and evaluation of documents for FDA and global submissions; and representing Incyte at health authority meetings.
• Support business development via review/due diligence of potential external assets.
• Support CMC as needed through safety evaluation of impurities, extractables/leachables, occupational safety evaluations (OELs, PDEs), and environmental risk assessments
• Manage a team of PhD toxicologists (project leads), pathologists, in-life scientists and laboratory animal staff.
• In-depth understanding of in vivo and in vitro biology, particularly molecular pathways in assessing risk and solving experimental questions in both pharmacology and toxicology.

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

• Ph.D. in Toxicology or related field. DABT certification desired.
• 15+ years related experience at director level or above in the pharmaceutical industry or related function.
• Management experience
• Demonstrate skills in written and verbal communications; organized and detail oriented.
• Demonstrate a thorough understanding of ADME, CMC and clinical functions, and ability to communicate effectively across disciplines in order to facilitate understanding and rapid resolution of issues.
• In depth understanding of global regulatory requirements, industry standards, and emerging trends in toxicology. Experience in filing IND/CTAs and NDAs for small and large molecules.
• Experience in developing risk mitigation strategies for emerging safety signals and communicating impact of signals in the context of both oncology and non-oncology drug development.

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)

• Develop investor confidence and belief in the Company’s vision and strategy for delivering shareholder value
• Develop a robust investor relations strategy and design and implement an investor relations program to ensure a consistent, timely flow of information about Incyte to the investment community and Company shareholders
• Develop and implement investor targeting strategy and related activities
• Partner with the CEO and CFO to lead and manage the Company’s participation on quarterly earnings calls, investment conference calls and in-house meetings, road shows, analyst days, and one-on-one meetings
• Establish strong internal relationships and collaborate with other relevant disciplines in creating the company’s external and internal messages and in ensuring that all company external and internal communications are integrated and consistent
• Develop relationships and maintain regular communication with individual investors and covering analysts to provide up to date information about events and market trends affecting the Company, with the goal of communicating our long-term vision
• Create and manage a strong reputation by demonstrating consistent and clear communication between internal and external parties
• Analyze and present financial trends, competitor behavior, shareholder issues, and anything else that could impact the business
• Provide insights on market activity and present them to the leadership team
• Develop IR communication materials
• Manage all Corporate IR/disclosure conference calls including presentations, conference call scripts and Q&As and schedules practice sessions
• Plan and manage special IR events including thematic days, R&D days, and other events
• Work with legal counsel to ensure compliance on regulatory matters
• Point person within the IR group for all Proxy related activities, including voter engagement, preparation of Proxy Statement and vote counting and analysis
• Help prepare the company’s 10-K, Proxy and ESG reports and manage the IR section of the corporate website
• Keep the IR calendar (visits, NDRS, conferences, presentations) and ensures efficient and effective use of company resources and achievement of all key deadlines
• Build, manage and develop the IR team

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

• Bachelor’s degree in business, finance or science.
• MBA or an advanced scientific or medical degree is a plus
• 10+ years dealing with investors in an Investor Relations role at a biopharmaceutical company and/or in a capital markets role
• Scientific background is a plus. Strong understanding of the biopharmaceutical industry is a must
• Strong track record of creating positive relations with the investor community and Equity Research analysts
• Strong understanding of macroeconomics, capital markets trends, competitor activities, industry dynamics, and customer trends
• Intimately familiar with financial modeling techniques and valuation methods used by analysts and investors
• Strong written and verbal communication skills, as well as strong track record in creating effective presentations and related written and digital materials
• Project management experience; ability to set priorities, quickly zero-in on critical tasks/issues, solution-minded / can identify ways to eliminate roadblocks. Ability to multi-task and work in a fast fast-paced environment
• Must be able to perform in a high-pressure environment, and be able to meet tight deadlines
• Ability to effectively communicate and partner with Incyte’s key stakeholders, both internally and externally, and be recognized as a trusted source of information and a team player
• Customer focus – can continuously identify the needs of key stakeholders and use these insights to maintain and improve relationships; can act with customers in mind and gain their trust and respect
• Strong understanding of SEC laws and securities disclosure requirements, as well as filing requirements
• Exceptional work ethic
• Clear values – has a set of core values and beliefs during both good and bad times; acts in line with those values, even in a crisis or under pressure

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 .