Instrumentation & Equipment Specialist II - Sunday to Wednesday - 3rd shift
Iovance Biotherapeutics Inc. Job In Philadelphia, PA
The Instrumentation and Equipment Specialist II is responsible for the maintenance, calibration and repair of equipment, utilities and systems supporting cGMP Manufacturing, Laboratories and Warehouse. Perform planned and corrective maintenance and calibration according to written instructions, diagnose issues in the field in real-time, propose corrective solutions, and complete and review related Facilities GMP documents. Ensure the safety and compliance of all applicable systems.
Shift: Sunday to Wednesday from 10pm to 8:30am
Essential Functions and Responsibilities
* Perform preventative, routine and corrective maintenance of CTU's, process utility systems, and manufacturing/laboratory instruments.
* An understanding of calibration / metrology and the ability to calibrate, adjust, and maintain measuring and indicating instruments to conform to set standards is highly desirable.
* An understanding of PLC's, HVAC, mechanical and electrical systems, and be able to troubleshoot and repair is highly desirable.
* Perform routine inspections of the facility, equipment and systems.
* Monitor, investigate and respond to alarms generated from the BMS/QEMS.
* Knowledge in the use of a wide range of standards, including temperature, relative humidity, differential pressure, CO2, flow, conductivity, resistivity, speed, time, pressure, and weight is highly desirable.
* Support Metrology to investigate OOT events using root cause analysis, metrics, technical knowledge and historical experience to identify and remediate.
* Ability to read and interpret engineering and architectural drawings, including floor plans, reflected ceiling plans, power plans, panel schedules, mechanical/plumbing piping diagrams, Piping & Instrumentation Diagrams (P&IDs)
* Write incident/deviation reports as necessary, perform root cause analyses and identify corrective actions as appropriate.
* Receive, filter and execute work order requests as necessary.
* Ensure that any equipment repairs or maintenance activities are compliant with any applicable building codes.
* Work with external vendors for the service and/or repair of equipment.
* Provide "On-Call" support as needed.
* Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.
* Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
* Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
* Bachelor's degree with 5 years of experience / Associates Degree with 10 years of experience is required.
* 5-10 years of related instrumentation and equipment experience in a GMP environment is required.
* Experience using Computerized Maintenance Management Software (Blue Mountain) is required.
* Experience using Building Management Systems and Environmental Monitoring Systems (Siemens Desigo or Insight) is required.
* Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
* Excellent oral and written communication skills required.
* Must have valid driver's license
Preferred Education, Skills, and Knowledge
* Prior experience in cell therapy manufacturing or BioPharma/Life Sciences is highly desirable.
* Experience working under ISO/IEC 17025 and/or ANSI/NCSL Z540.3 management systems is preferred.
* Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations is preferred.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required:
* Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
* Must meet requirements for and be able to wear a half-face respirator.
* Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
* Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
* Must be able to lift and carry objects weighing 45 pounds.
Mental:
* Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline
Work Environment:
* This position will work in both an office and a manufacturing lab setting.
* When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
* Able to work in cleanroom with biohazards, human blood components, and chemicals.
* Potential exposure to noise and equipment hazards and strong odors.
#LI-onsite
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************.
By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
Supervisor, Quality Control
Iovance Biotherapeutics Inc. Job In Philadelphia, PA
The Supervisor, Quality Control Analytics role will support the Quality Control (QC) Analytics programs and testing operations at Iovance's integrated Cell Therapy Center (iCTC). The QC Analytics testing operations include but are not limited to, in-process, final drug product, and stability testing for clinical and commercial lots. This role requires hands-on experience in at least two of the following: cell maintenance and cell count determination (NC-200), cell-based potency using various immunoassays (ELISA, etc.) and/or identification/characterization/potency assays using multi-color flow cytometry platforms. This position supports the ramp-up of QC Analytical release assays and other activities in a newly built facility for cell therapy products.
This role will apply appropriate cGMPs and regulatory requirements in the product development life cycle, including, but not limited to, lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures. The Supervisor, Quality Control Analytics role will have direct oversight of the QC analysts and performance. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to meet target turn-around times.
Essential Functions and Responsibilities
* All duties are performed independently with minimal supervision and oversight.
* Supervise the execution of all laboratory activities, including release testing and laboratory maintenance activities.
* Supervise the technical transfer, qualification, and validation of QC Analytical test methods for in-process materials, lot release, and/or stability, as needed.
* Perform daily GMP QC laboratory testing activities at the iCTC facility.
* Author, review, and approve SOPs, protocols, reports, specifications, and other QC documents.
* Ensure trending data input for all generated data is performed timely.
* Lead investigations for out-of-specification test results, corrective actions, and verification of effectiveness.
* Support product stability programs including generation of stability protocols, execution of stability testing, and transfer of stability results to external QC.
* Ensure that the daily GMP QC laboratory testing activities at the iCTC facility are executed with minimal to no errors and ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
* Increase breadth of technical abilities through qualification on all QC analytical release assays.
* Serve as a qualified trainer on all QC analytical release assays, as needed.
* Serve as a qualified technical reviewer on all QC analytical assays, as needed.
* Support professional development of QC Analytics team members.
* Establish positive working relationships with internal and cross-functional teams.
* Support problem solving for technical issues pertaining to GMP QC, working alongside technical SMEs, as needed.
* Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
* Support Health Authority inspections.
* Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.
* Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
* Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
* Minimum five (5) years of experience in the biopharmaceutical industry within a QC role with a Bachlor's degree, or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience.
* Solid understanding and functional knowledge with hands-on experience with at least one of the following: Cell Based Potency Assays and supporting ELISA platforms and/or Multi-color flow cytometry for identification, characterization, and potency analysis.
* Broad knowledge of biological drug development with respect to QC.
* Proficient in technical writing (e.g., test methods, SOP's, protocols, etc.)
* Extremely detail-oriented with strong technical skills
* Strong written and verbal communication skills
* Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
* Demonstrate sense of urgency; ability to recognize time sensitivity.
* Flexible and adaptable style with an eagerness to take on challenges.
* Problem solver who not only identifies issues but leads efforts to resolve them.
Preferred Education, Skills, and Knowledge
* Advanced degree in a relevant discipline (biological sciences or equivalent)
* Experience supervising a team
* Experience with cell and/or gene therapy products
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required:
* Must be able to wear appropriate Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
* Must meet requirements for and be able to wear a half-face respirator.
* Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
* Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
* Must be able to lift and carry objects weighing 30 pounds.
Mental:
* Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment:
* This position will work in both an office and a QC laboratory setting.
* When in the lab, must be able to work in laboratory setting with various chemical/biochemical exposures.
* Potential exposure to noise and equipment hazards and strong odors.
#LI-onsite
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual's race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact *******************.
By voluntarily providing information and clicking "Submit Application", you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
Senior Drug Safety Operations Manager
King of Prussia, PA Job
SUMMARY/JOB PURPOSE: This role is responsible to assist with overseeing all aspects of drug safety study operational activities from study start up to close out. This role assists with oversight of clinical trial safety operational vendor activities and supports all major tasks related to the management and best utilization of case processing activities in the Argus Safety Database, ensuring compliance with global clinical safety and PV regulations and Global Patient Safety (GPS) department procedures in all aspects of drug safety case processing and reporting.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Technical duties include but are not limited to:
* Process and assess SAEs and AEs from receipt at Exelixis to case closure in the Argus database, including query generation, MedDRA coding and narrative writing.
* Manage, define, and apply a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician.
* Train new safety staff on Argus and case processing.
* Collaborate with other Exelixis departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data. Leads cross-functional projects, obtains input, and gains consensus where needed on safety operational topics.
* Perform Safety Study Lead activities including Review of, Investigator Brochures, study protocols and participation in IND Annual Reports in support of the Drug Safety Physician. Development of study-specific and program-level safety management plan from CRO or Exelixis GPS template. Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and CRF).
* Monitor activities of CRO's and partners to ensure adherence and compliance with applicable SMPs, PVAs, and other contractual agreements involved in study lead activities.
* In collaboration with Data Management, perform SAE reconciliation activities per study level plans.
* Develop and/or update SOPs, processes and practices for study lead and SAE case processing activities in accordance with drug safety and pharmacovigilance regulations and standards.
* Lead self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals.
* Additional duties and responsibilities as required.
SUPERVISORY RESPONSIBILITIES:
* None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
* BS/BA degree in related discipline and a minimum of 9 years of related experience; or,
* MS/MA degree in related discipline and a minimum of 7 years of related experience; or,
* PhD in related discipline and a minimum of 2 years of related experience; or,
* Equivalent combination of education and experience.
* May require certification in assigned area.
Experience/The Ideal for Successful Entry into Job:
* BS or MS in Nursing, Pharmacy or other clinical degree with a minimum of eight years of clinical experience.
* Experience in Biotech/Pharmaceutical industry and/or in oncology preferred.
* Experience using Argus safety database preferred.
* Clinical trial and spontaneous adverse event processing experience.
Knowledge/Skills:
* Knowledge of biotechnology/pharmaceutical sector practices.
* Wide knowledge of relevant regulations and guidance governing patient safety.
* Demonstrates skill and insight in gathering, sorting and applying key information to solve problems.
* Demonstrates an understanding of organizational and planning capabilities by managing own time to complete assigned work.
* Leads self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals.
* Demonstrates clear and effective verbal and written communication.
* Works collaboratively with team members to achieve alignment. Engages stakeholders to establish collaborative relationships.
* Good interpersonal skills and emerging ability to bring differing views to develop an agreed upon resolution.
* Trains on procedures, tasks and tools for role, supported by ongoing coaching and/or mentoring by departmental peers. Develops and maintains knowledge of cross-functional products, tools and data sources. May mentor junior team members.
* Applies strong analytical and business communication skills.
JOB COMPLEXITY:
* Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May work on significant and unique issues where analysis of situations or data.
* Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
* Anticipates, identifies, prioritizes, and resolves task-related challenges, and escalates issues as needed.
* Creates formal networks involving coordination within the Global Patient Safety department and with cross-functional teams.
WORKING CONDITIONS:
* Environment: primarily working indoors, performing clerical work.
#LI-MB1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $149,500 - $213,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Scientific Regulatory Writing Director
King of Prussia, PA Job
SUMMARY/JOB PURPOSE: Leads content development for various regulatory and clinical documents to support multiple assets across all phases of asset development. Examples include clinical and nonclinical summaries for IND/NDA/BLA/MAA, briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports, and other types of complex cross-functional documents and reports as needed.
DUTIES/RESPONSIBILITIES:
* Independently leads content development for regulatory and clinical documents by composing (writing), developing, reviewing, and editing content. Integrates various sources of information into a uniform style and presentation for the intended audience.
* Incorporates diverse reviewer feedback while ensuring high quality of content organization, including completeness, clarity, coherence, conciseness, consistency, and accuracy.
* Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed to create descriptive text and in-text tables.
* Assigns and supervises partner regulatory editors for all document tasks unrelated to writing.
* Proposes and manages timelines for the document development process from initiation through approval.
* Oversees the assembly of appendices for regulatory submission documents as needed.
* Serves as the primary writing contact on regular and ad hoc study/program/asset or project teams.
* Provides writing guidance to internal teams based on organizational goals and company policy, with responsibility for results.
* Peer reviews project work and training materials/guidelines drafted by Regulatory Science Communications team members.
* Contributes to SOP and work instruction development and review for the Regulatory Science Communications team.
* Other duties as needed.
SUPERVISORY RESPONSIBILITIES:
* No direct reports.
* Supervises work of junior writers and regulatory editors on document tasks.
* May direct and review the work of contract writers as needed.
* Mentors less experienced writers.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
* BS/BA degree in related discipline and a minimum of thirteen years of related experience including industry; or,
* MS/MA degree in related discipline and a minimum of eleven years of related experience including industry; or,
* PhD in related discipline and a minimum of eight years of related experience including industry; or,
* Equivalent combination of education and experience.
* Active AMWA member with certificate or certification preferred; BELS certification a plus.
Experience:
* Experience in Biotech/Pharmaceutical industry is required.
* A minimum of seven years of regulatory/medical/technical writing or equivalent writing experience in the pharmaceutical industry, including experience supervising less experienced writers.
* Experience and significant participation in leading content development for regulatory and clinical documents for regulatory submissions (e.g., IND/NDA/BLA/MAAs, clinical protocols, CSRs, IBs).
* Experience and use of electronic literature tools to obtain scientific/medical abstracts and publications.
* Familiarity with the therapeutic area of oncology is essential.
* Advanced knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidelines, and GCP standards.
* Advanced knowledge of AMA style, medical terminology, and clinical data analysis.
* Professional certification (e.g., AMWA, BELS) is beneficial.
Knowledge, Skills and Abilities:
* Develops and manages plans, establishes timelines, and sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high-quality work.
* Applies extensive knowledge of the regulatory framework, industry drivers, and practices to develop innovative approaches and manage complex work.
* Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to cross-functional groups of colleagues.
* Strong interpersonal skills and ability to accommodate differing views to influence an agreed-upon resolution.
* Facilitates team alignment and achievement of common objectives. Engages internal and external stakeholders to establish productive collaborative relationships.
* Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing, and applying key information to solve problems. Provides regulatory writing expertise to cross-functional teams. Understands the longer-term consequences of decisions and actions.
* Acts with integrity to build trust and execute on team objectives that contribute to departmental goals.
* Capable of proactively assessing workload, trends, tasks, and priorities for the area of responsibility.
* Plans and executes multiple activities.
* Considers alternative methods and contingency plans to avoid potential issues.
* Designs and implements solutions to address project-level challenges, taking into consideration the broader impact.
* Environment: primarily working indoors.
#LI-MB1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $171,000 - $243,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Associate Biostatistics Director
King of Prussia, PA Job
SUMMARY/JOB PURPOSE: Applies extensive technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases. Uses initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design. Works collaboratively with clinicians, data managers, biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials.
Essential Duties And Responsibilities:
* Work with project team members on developing clinical protocol. Review CRFs, CRF edit checks and CRF completion guidelines. Author statistical analysis plan, TLF shells and Table of contents for outputs to be generated. Review ADaM specifications and verify primary and secondary efficacy endpoints.
* Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
* Effectively manage CRO to ensure high-quality deliverables within timeline and budget.
* Oversee programming of ADaMs and TLFs for the study.
* Responsible for one or more studies with concurrent tasks and timelines.
* Participate in the validation/QC of key study endpoint analysis and submission deliverables.
* Apply appropriate regulatory guidelines to the projects.
Supervisory Responsibilities:
* None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
* MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
* PhD in related discipline and a minimum of 5 years of related experience; or,
* Equivalent combination of education and experience.
* May require certification in assigned area.
Experience/The Ideal for Successful Entry into Job:
* Experience in oncology and study Phases I-III highly preferred.
* Experience in Biotech/Pharmaceutical industry preferred.
* Experience with managing CROs in the conduct of clinical trials.
* Experience with statistical applications and clinical data management procedures in the conduct of clinical trials.
* Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.
Knowledge/Skills:
* Knowledge of appropriate regulations, industry standards and guidance documents.
* Ability to interact effectively with biostatistical, data management, operations, and clinical personnel from CROs and companies collaborating with Exelixis.
* Developed/reviewed SDTM/ADaM specifications
* Strong SAS programming knowledge.
* Guides the successful completion of major programs, projects and/or functions.
* Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
* Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
* Develops technical and/or business solutions to complex problems.
* Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
* Performs a variety of complicated tasks with a wide degree of creativity and latitude.
* Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
* Has good general knowledge of other related disciplines.
* Applies strong analytical and business communication skills.
JOB COMPLEXITY:
* Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
* Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.
* Creates formal networks involving coordination among groups.
#LI-JD1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $166,000 - $236,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Senior Corporate Counsel, Commercial
King of Prussia, PA Job
SUMMARY/JOB PURPOSE: The Senior Corporate Counsel, Commercial is responsible for providing commercialization legal support, advice and counsel in connection with planning, tactics and strategies undertaken by the Commercial Department of the Company, primarily the Market Access function. The attorney in this position will provide direct regulatory advice and transactional support for Exelixis' relationships with key customers and business partners, including but not limited to group purchasing organizations, large hospital networks, PBMs, specialty pharmacies, and distributors. The attorney in this position will also be responsible for providing legal advice related to government price reporting requirements.
* This is an onsite role (5 days a week, Monday through Friday) based at our Alameda, CA headquarters.*
ESSENTIAL DUTIES AND JOB RESPONSIBILITIES
* Provide direct legal support to the Commercial-Market Access department, in the furtherance of their operational responsibilities and in a manner consistent with the requirements of the Company's Healthcare Compliance Program.
* Advise Commercial-Market Access department on compliance with government price reporting requirements.
* Draft, review and negotiate contracts in support of the Commercial department, including purchase and distribution agreements and PBM agreements.
* Ongoing tracking and evaluation of legal and regulatory developments at the Federal and state levels pertinent to the commercialization of innovative pharmaceuticals, including but not limited to guidance and advisories from FDA, OIG, DOJ, CMS, and other relevant government agencies.
* Advise and troubleshoot on existing agreements.
* In collaboration with the Healthcare Compliance function and taking into consideration input from operational clients and colleagues, maintain and modify Company policies and SOPs in a risk-based manner, as necessary to reflect changes and clarifications to applicable laws and regulations, develop associated written guidance, and conduct live or web-based training to operational teams.
* Assist Healthcare Compliance with the monitoring and auditing of Commercial activities, including periodic field-based monitoring activities.
* Participate in the investigation of complaints and alleged violations of rules, regulations, policies, procedures, and standards of conduct, and coordinates with management in developing/implementing corrective action plans and provides general guidance on such matters.
* Handle a broad variety of miscellaneous legal tasks on an as needed basis.
SUPERVISORY RESPONSIBILITIES:
* Provides direction to other Exelixis employees; may supervise staff.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
* BS/BA degree; optimally in life sciences or a related field.
* JD degree required and must be admitted to practice, preferably in California.
Experience:
* At least 6 years of experience as an attorney in a law firm or in-house legal department, with a focus on providing transactional and regulatory advice regarding marketed products in the biopharmaceutical or biotechnology industry.
* Contract drafting and negotiation experience required.
Knowledge/Skills:
* Thorough knowledge of laws, regulations, and guidance applicable to various biopharmaceutical commercial initiatives.
* Thorough knowledge of processes related to the drafting, negotiation, and review of various commercial contracts.
* Excellent interpersonal skills with the ability to articulate legal advice in a clear, concise, and complete manner, both verbally and in writing.
* As a visible representative of the Legal department with responsibility for the enforcement of Company polices and ethical standards, must exercise strong, positive leadership and influencing skills.
* Must have a record of professional performance and personal integrity reflective of good judgment and the ability to apply legal principles to business facts in a reasonable manner.
* Must be detail-oriented and have strong organizational skills.
* Ability to handle multiple tasks simultaneously and with the ability to re-prioritize on short time frames.
* Acts responsibly and conscientiously.
* Works under pressure to meet specific deadlines.
* Works independently and in a cross-functional team environment.
* Dedicated to quality, reliability, and highest professional standards in all work tasks.
WORKING CONDITIONS:
* Environment: primarily working indoors, performing clerical work
#LI-HG1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $208,000 - $295,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Assoc Scientific Publications Director
King of Prussia, PA Job
SUMMARY/JOB PURPOSE: Scientific Publications is a group within Medical Affairs with responsibility for development of scientific publications and publication planning. The Associate Scientific Publications Director plans publication strategy and works to develop, coordinate and execute publications tactics. This includes developing robust publication plans, and managing development of scientific presentations, and publications.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Operate in accordance with all Exelixis SOPs, including the Publications SOP, and promote the adoption of working standards consistent with Good Publication Practice.
* Contribute to strategic, operational and tactical planning for the Exelixis Publication Plan.
* May write and revise abstracts, posters, case reports, and manuscripts for submission to scientific congresses or peer reviewed journals.
* Work with publications and writing vendors as needed.
* Coordinate with internal and external stakeholders; ensure execution of abstracts, posters, oral presentations and manuscripts in accordance with timelines as set in the publication plan.
* Use the Datavision publications portal to monitor feedback on publications
* Collaborate with other members of the Medical Affairs organization (e.g. Medical Science Liaisons, Medical Information, Medical Research, etc) in support of their functional area deliverables.
* Attend scientific conferences to enhance therapeutic knowledge and to contribute to execution of Medical Affairs conference deliverables.
* Develop product and disease state expertise, keep abreast of the changing drug development environment.
* Other duties and responsibilities as assigned.
SUPERVISORY RESPONSIBILITIES:
* None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
* Bachelor's level degree in related discipline and a minimum of eleven years of related experience; or,
* Master's level degree in related discipline and a minimum of nine years of related experience; or,
* Doctorate level degree (PharmD, MD, PhD) and a minimum of five years of related experience; or,
* Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
* Oncology experience preferred.
* Experience in pharmaceutical/biotech desirable.
* Significant experience with publication development and writing is required.
* Understanding of clinical trial design, interpretation of scientific data and communication via clinical and medical affairs channels, preferred.
Knowledge/Skills:
* Excellent organizational, time, and project management skills.
* Skilled medical/technical writer with attention to detail.
* Self-motivated, organized, problem-solving, solution-oriented, collaborative team player.
* Strong skills with regard to written and verbal communication of complex medical and scientific data to a variety of audiences.
* Strong interpersonal and collaboration competencies for interfacing with a wide range of internal and external cross-functional partners.
* Ability to foster relationships, build alignment, negotiate, and collaborate with internal and external stakeholders.
* Ability to work independently and manage multiple projects in a fast-paced and dynamic environment.
JOB COMPLEXITY:
* Works in a fast-paced, small-team environment that is growing and evolving. This position requires regular reprioritization of projects while adhering to timelines and achievement of deliverables.
WORKING CONDITIONS:
* Occasional travel required to support medical affairs activities at scientific congresses and company meetings.
#LI-MB1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $158,000 - $224,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Sr. Specialist to Manager, Medical Operations
Chadds Ford, PA Job
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function): This position is responsible for operational oversight and support of multiple US Medical Affairs (USMA) projects and contributes to the development of project timelines and priorities.
Required to be in the office 4 days per week allowing for 1 day remote.
Essential Functions of the Job (Key responsibilities): Advisory Board & Consulting Agreement Management: · Partner with USMA colleagues to support timely execution of agreements for advisory boards and other consulting engagements.
· Perform fair market value (FMV) assessment on each advisor, considering qualifications, consulting hours, and travel requirements as applicable.
· Coordinate negotiation and execution of consulting agreements between legal teams and external consultants.
· Collaborate with third-party vendors to support planning and logistics as needed.
· Support the submission of purchase orders (POs) related to consulting agreements.
· Maintain a centralize tracker to monitor and document both planned and completed advisory boards throughout the year.
Investigator-Initiated Research (IIR) Submission and Review: · Provides operational leadership for the US Oncology IIR submission and review process, working collaboratively with USMA Medical Directors, IIR Program Managers, Medical Science Liaisons (MSLs), Clinical/Pre-Clinical Development, and relevant Alliance Partners.
· Facilitate effective cross-functional communication among USMA functional leads, Clinical Development, and other key stakeholders by leveraging appropriate communication methods.
Responsibilities include coordinating meeting logistics, developing agendas, documenting minutes, and providing facilitation support for various teams and sub-teams, as needed.
· Maintain and continuously update IIR trackers and performance metrics to ensure accurate, real-time portfolio visibility; proactively identify risks and escalate issues to management to enable timely resolution and strategic decision-making.
· Oversee the vendor relationship for US Oncology IIRs, ensuring alignment with contractual obligations and operational expectations; deliver comprehensive training to new USMA users on the IIR platform and provide ongoing support for external stakeholders, including troubleshooting access issues and facilitating system navigation.
Project Management of Pre-Clinical IIRs: · Provides operational oversight of early-stage research initiatives, including startup activities, contract coordination, and management of drug supply and financial processes.
· Collaborate with Investigators and site staff to ensure timeline study start up, activation, execution and closure of studies, as well as FMV budget assessment and contract finalization, in close collaboration with legal colleagues.
Other Activities and Operational Support: · Participates in the development and maintenance of standard operating procedures (SOPs) for various MA functional groups and activities.
· Develop and implement performance metrics to monitor and evaluate progress within areas of responsibility.
Qualifications (Minimal acceptable level of education, work experience, and competency): · Bachelor degree (B.
A.
, B.
S.
) is required.
· Experience in the pharmaceutical/ biotechnology industry or related fields.
· Proven Project Management experience is required.
· Demonstrated high level of competence with computers is essential; to include extensive experience with MS Office Applications (including project management specific applications) is required.
Experience with document management, storage and retrieval systems is also required.
· Demonstrated success in establishing successful working relationships with a diverse range of internal and external key stakeholders.
· Must be a dependable self-starter and be capable of working independently on multiple projects with the ability to prioritize tasks and meet strict deadlines.
· Must possess excellent organization skills, and be able to operate effectively in a heavily metricized organization, where a demanding workload requires flexibility and balancing multiple responsibilities 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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
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 here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.
Clinical Development Medical Director
King of Prussia, PA Job
SUMMARY/JOB PURPOSE: In collaboration with the Exelixis clinical teams, the primary role is to lead and execute late stage clinical trials for oncology products in development. Participates in the design/planning of clinical studies and helps with the interpretation of study results. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators for research studies. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Monitors adherence to protocols and determines study completion.
Essential Duties And Responsibilities:
* Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
* Act as medical monitor for company sponsored trials.
* Support project teams with therapeutic area specific information.
* Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials.
* Analyze and interpret other clinical trial data and prepare reports for regulatory agencies and publication.
* Interact with key opinion leaders and investigators in relevant disease specific area.
* Ensure consistency of scientific and development strategies for oncology products in development.
* Maintain the highest level of scientific and clinical knowledge in relevant disease specific area.
Supervisory Responsibilities:
* None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
* MD (board certification or eligibility in Oncology or Hematology/Oncology desirable but not essential) required with a minimum of 5 years of post-residency experience.
* Equivalent combination of education and experience
Experience/The Ideal for Successful Entry into Job:
* Drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic experience but without experience in the pharmaceutical industry may be considered
* Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology.
* Participated in clinical oncology studies with molecular targeted or immunological therapies.
* Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).
Knowledge/Skills:
* Proven ability to effectively work in a cross-functional/matrix environment
* Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
* Develops technical and/or business solutions to complex problems.
* Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
* Ability to develop and maintain relationships with significant key opinion leaders.
* Strong interpersonal, influencing, presentation, and written and verbal communication skills
* Strong organizational and time management skills
JOB COMPLEXITY:
* Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
* Works on abstract problems across functional areas of the business
* Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
* Regularly interacts with executives and/or major customers.
#LI-JD1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $221,000 - $313,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
BIS AI / ML Data Engineer - ONC
Chadds Ford, PA Job
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function) The Sr Manager, Business Information Services, AI/ML Engineer - Oncology is part of the Business Operations team within Incyte's US Oncology Business Unit.
This role will be a key contributor in expanding Incyte Oncology's AI/ML competency and will focus on designing, developing, and deploying cutting-edge machine learning and AI solutions.
Reporting to the Associate Director, BIS, Data Engineering, the incumbent will focus on developing scalable machine learning, predictive analytics, and data engineering to build and productionize impactful models and workflows that drive informed decision-making across the Oncology organization.
This role will work closely with various business teams across the Oncology business unit to translate business requirements into machine learning solutions, as well as independently manage end-to-end projects in a fast-paced environment.
The ideal candidate will have a strong technical background with a comprehensive understanding of cloud platforms, data engineering experience with structured and unstructured data, and hand-on experience developing and deploying AI/ML models at scale.
An ability to work independently, communicate effectively, and manage projects efficiently will be crucial to success in this role.
Essential Functions of the Job (Key responsibilities) Key responsibilities of this role include designing, developing, and deploying data engineering and machine learning models to address complex problems across a variety of business teams within the Oncology business unit.
For machine learning, the primary objective is to achieve process and decision automation through building, training, and fine-tuning models while ensuring scalability, efficiency, and accuracy.
Engineering responsibilities span multiple components: (1) data acquisition and preparation including collecting, cleaning, and preprocessing data, (2) performing feature engineering to optimize model performance, and (3) integration of models or workflows into existing Incyte business systems.
Keeping abreast of the latest advancements in artificial intelligence and machine learning, as well as experimenting with new algorithms, frameworks, and tools, is an essential aspect of this role.
Additionally active engagement in knowledge sharing and collaboration with cross-functional teams and business stakeholders-including Incyte's Oncology and Dermatology portfolios, IT, and Compliance-is essential for driving synergies and delivering streamlined AI/ML solutions.
Specific areas of responsibilities · Design, build, and deploy machine learning and predictive models to solve business problems.
· Develop, implement, and maintain data pipelines using Azure Data Factory, connecting with various data sources, including blob storage and SQL databases.
· Actively contribute to and enforce data security and governance through tools or platforms such as Purview and Databricks · Use Databricks to analyze, process, and transform large datasets, preparing them for machine learning models and reporting.
· Work with large language models (LLMs) like ChatGPT to integrate conversational AI features, leveraging API programming for seamless interaction with applications.
· Design and implement data models and work with graph databases to support predictive analytics and complex data relationships.
· Create interactive dashboards and applications with R Shiny for data visualization and decision-making support.
· Develop and maintain APIs to enable efficient data communication between various systems and applications.
· Collaborate with stakeholders to understand business requirements, presenting insights and model outcomes in a clear, actionable manner.
· Independently manage project timelines, deliverables, and documentation, ensuring alignment with business objectives and regulatory standards.
Qualifications (Minimal acceptable level of education, work experience, and competency) · BS in Computer Science, Information Systems, Engineering, or a related field.
Advanced degree or relevant certifications preferred.
· Must have a combined 3 - 5 years of hands-on experience building AI/ML solutions in industry and/or academia.
Technical Skills: · Demonstrated proficiency in Python for data processing, machine learning model development, and API integration required.
· Experience in R and R Shiny for creating interactive data visualizations and applications.
· Experience with Azure Cloud Platform and Azure Data Factory for creating data pipelines and connecting to various data storage systems, including blob storage.
· Strong knowledge of Databricks for data engineering and model training in distributed computing environments.
· Familiarity with large language models (LLMs), such as ChatGPT, for building conversational AI and natural language processing applications.
· Proven experience with SQL databases, including Azure Synapse, for complex querying, data integration, and reporting.
· Knowledge of graph databases and data modeling to support predictive analytics and relational data structures is a plus.
· Skilled in API programming to facilitate secure, efficient integration between systems.
· Competency in predictive modeling techniques and machine learning algorithms for real-world applications.
· Proficiency in data modeling techniques for structuring and organizing data to support analytics.
Soft Skills: · Strong communication skills with the ability to translate technical insights for non-technical stakeholders.
· Project management experience to independently handle multiple projects, ensuring timely and high-quality delivery.
· Ability to work independently, demonstrating self-motivation and a proactive approach to problem-solving.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
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 here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.
Commercial Regulatory Affairs Director (Advertising and Promotion)
King of Prussia, PA Job
SUMMARY/JOB PURPOSE: Responsible for primary regulatory review of promotional materials and scientific exchange communications. This role demonstrates proficiency in understanding and interpreting Federal regulations and guidance documents and company standard operating procedures (SOPs) to support the advertising and promotions of Exelixis' FDA (Food and Drug Administration) approved products, as well as materials for scientific-exchange communications. This role recognizes the different requirements and restrictions for external data communication and presentation and represents the Regulatory considerations and point of view. This role demonstrates cross-functional leadership, recognizing opportunities for multi-disciplinary collaboration and challenges regarding communication strategies and initiatives that cross multiple channels.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Ensures compliance with all FDA regulations for prescription drug, advertising, and promotions, provides regulatory guidance for the development, review, approval, and implementation of promotional materials and other related activities with an increased level of independence.
* Provides timely and solutions-oriented reviews of assigned advertising and promotion materials with a high level of independence.
* Responsible for the regulatory review and approval of advertising and promotional materials and scientific exchange communications. Serves as decision-making member of the Review of Advertising, Marketing, and Promotions (RAMP) committee and/or Medical Review committee (MRC).
* Serves as RAMP Chair overseeing the review and approval of RAMP and/or MRC materials. Able to recognize issues requiring escalation and lead RAMP through escalation process.
* Provides regulatory guidance for the development, review, implementation, and maintenance of promotional materials and other related activities with a high level of independence.
* Effectively collaborates with cross-functional internal groups including Marketing, Legal, Medical, Market Access, and other groups as needed.
* Manages the development of relevant correspondence with health authorities and interpretation of health authority comments.
* Responsible for the regulatory review and approval of scientific exchange materials, including Medical Information requests, materials for the Medical Affairs field staff, and clinical trial support materials (e.g., external patient recruitment materials). Decision-making member of the Medical and Scientific Exchange Review Committee.
* Reviews and approves clinical development communications and materials in support of Exelixis clinical trials, including site training slides and newsletters.
* Effectively collaborates with cross-functional internal groups including Marketing, Legal, Medical, Market Access, and other groups as needed.
* Provides strategic and forward-looking guidance regarding processes and systems surrounding review committees.
* Provides leadership within the Commercial Regulatory Affairs department, identifying and managing through completion departmental and cross-project initiatives and regulatory obligations.
* Responsible for oversight of promotional material submissions under Form FDA 2253.
* Maintains current awareness of evolving health authority interpretations, including advisory letters, enforcement letters, policy issues and guidance recommendations. Conducts benchmarking project for new initiatives and/or activities.
* Reviews and evaluates industry environment; performs competitive intelligence on promotional materials and activities.
* Manages, maintains, and continuously improves processes and systems (including a web-based platform) for review and approval of promotional materials. Oversee and manage training on processes and systems.
* Leads creation and maintenance of Commercial Regulatory SOPs and work instructions for review, approval, and maintenance of promotional materials.
* Mentors and provides oversight to junior department members supporting Commercial Regulatory Affairs activities.
SUPERVISORY RESPONSIBILITIES:
* None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
* Bachelor's degree in related discipline and a minimum of thirteen years of related experience; or,
* Master's degree in related discipline and a minimum of eleven years of related experience; or,
* PhD degree in related discipline and a minimum of eight years of related experience; or,
* Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
Knowledge/Skills:
* Develops and manages plans, establishes timelines, sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high quality work.
* Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work.
* Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to cross-functional groups of colleagues.
* Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.
* Manages effectively performing teams, facilitates team alignment and achievement of common objectives. Engages internal and external stakeholders to establish productive collaborative relationships.
* Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.
* Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives that contribute to departmental goals.
JOB COMPLEXITY:
* Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility.
* Plans and executes multiple activities.
* Considers alternative methods and contingency plans to avoid potential issues.
* Designs and implements solutions to address project level challenges, taking into consideration the broader impact.
WORKING CONDITIONS:
* 10% travel (as needed).
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department. Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.
#LI-MB1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $167,500 - $237,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Sr. Manager,Commerical Training
Chadds Ford, PA Job
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary This position is a hybrid role with onsite in the Chadds Ford, PA office 2-3 days a week.
Field travel will also be required.
The office will be relocating to Wilmington, DE in 2026.
Candidate must be within driving distance to the office, to be considered.
Reporting to the Director of Commercial Training, this training position is responsible for meeting and exceeding the Sales and Management training requirements of the Commercial organization at Incyte.
Summary of the Essential Functions of the Job Responsibilities will include, but are not limited to, the following: · Be a subject matter expert and product/disease state lead as assigned by Director.
· Design, develop and deliver training curriculum and content which may include disease state, clinical, strategic and/or skill based training.
· Develop, coordinate and facilitate training programs such as new hire classes, virtual workshops, National Meeting workshops, learning modules, Launch training and other training materials.
· Manage vendors when designing and developing training content.
· Work with Director and sales management to institute specific metrics and measurements to assess the success of training activities.
· Manage classroom environment in a manner that allows for adult learning and clinical/sales proficiency.
· Coach and provide feedback to representatives during training sessions.
· Design, execute and facilitate National/Regional Sales Meeting training workshops.
· Manage training projects through the Medical, Legal and Regulatory review process.
· Facilitate live and virtual training sessions of varied sizes.
· Partner with cross functional teams (Marketing, Field Sales Management, Sales Operations, Medical, etc.
) to build and provide training to support corporate strategy.
· Act as a resource for the field force by actively participating in all sales meetings and routine field rides.
Minimum Requirements · Bachelor's Degree required · 5 years successful sales experience in hematology/oncology/ immune-oncology is preferred · 2-3 years of training experience preferred · High level of professionalism and the ability to excel in a team environment.
· High clinical affinity and ability to master new clinical areas.
· Effectively manage multiple projects in a fast paced, changing environment.
· Ability to work in a cross functional and matrix environment.
· Ability to be strategic and creative in the design of training programs.
· Strong organizational and multi-project management skills with the ability to manage and prioritize concurrent projects.
· Exceptional presentation/facilitation skills and written communication skills to varying management levels.
· Ability to self-motivate, independently perform and demonstrate leadership skills.
· Proven success at performing responsibilities with a high degree of flexibility, objectivity, discretion, appropriate demeanor, and professionalism.
· Expertise with key software is preferred (e.
g.
MS PowerPoint, MS Word, MS Excel, Webex, Outlook, LMS, etc.
).
· Willingness to travel up to 50% of the time.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
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 here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.
Manager-Senior Manager, Sales Operations
Chadds Ford, PA Job
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary The Senior Manager, Sales Operations plays a key role in supporting the execution of Incyte's commercial strategy across one or more therapeutic areas.
This individual will partner with Field Sales, Marketing, Finance, Compliance, HR, and Commercial Operations to ensure field teams are equipped with the right tools, insights, and structures to perform effectively.
The role will be responsible for incentive compensation (IC), sales performance analytics, territory alignments, and other field enablement activities.
This role blends tactical execution with strategic insight to help drive performance across the field sales organization.
Essential Functions of the Job (Key responsibilities) · Manage and execute field incentive compensation programs including quota setting, IC plan design execution, exception handling, reporting, and payout processing.
· Support territory alignment management, including regular updates, change requests, and analysis to optimize coverage and resource deployment.
· Serve as the primary operations point of contact for assigned brands or business units, providing support for reporting, targeting, data requests, and salesforce effectiveness metrics.
· Develop and maintain standardized reports and dashboards to enable field visibility into performance and execution.
· Provide ad hoc field performance analytics and insights to sales leadership to support business decisions and field team effectiveness.
· Manage and deliver Sales Operations training for field sales teams on tools, processes, reports, and operational updates to ensure optimal usage and understanding.
· Collaborate with Commercial IT, Business Insights & Strategy (BIS), and Data Management to ensure data integrity and enhance reporting systems.
· Support product launches and commercial readiness activities from a sales operations perspective.
· Drive continuous improvement by identifying opportunities to optimize processes, automate reporting, and scale support as the business evolves.
· Participate in cross-functional projects, including system upgrades, data integrations, and strategic field initiatives.
Qualifications (Minimal acceptable level of education, work experience, and competency) Education and Experience: · Bachelor's degree in business, analytics, life sciences, or related field or relevant experience.
· Previous of experience in pharmaceutical, biotech, or healthcare-related sales operations or commercial operations roles.
· Experience supporting field sales teams, particularly in areas such as incentive compensation, reporting, salesforce structure, or call planning.
· Experience with sales force strategy, including resource sizing, deployment, or performance measurement.
· Experience working with CRM systems (e.
g.
, Veeva), analytics platforms (e.
g.
, Tableau, Power BI), and data management tools is preferred.
Skills and Competencies: · Analytical and detail-oriented with a strong understanding of data structures and sales performance metrics.
· Strong Excel skills; intermediate-level SQL and Power BI proficiency required.
· Ability to manage multiple priorities and communicate effectively across functions and levels.
· High degree of discretion when handling confidential and sensitive information.
· Demonstrated ability to work both independently and in a team-oriented 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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
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 here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.
Associate Clinical Data Management Director
King of Prussia, PA Job
SUMMARY/JOB PURPOSE: Provide oversight for the execution of data management activities at the program level (for an indication or for multiple studies within an indication) from study start up through to regulatory submission. In collaboration with cross-functional teams, external partners, and support Data Managers, may serve as the lead study data manager for a large, complex trial or multiple, smaller studies. Will support CDM process improvement initiatives. Participate in staff recruitment, onboarding, training, and mentoring.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* As the main point of contact to Study Team, work collaboratively with cross-functional team members to meet project deliverables with quality and per agreed timelines
* Lead the planning and execution of data management activities on assigned studies
* Ensure all Data Management study documents are developed and archived
* Establish and lead the Data Working Group (DWG) for assigned study
* Develop and maintain Data Management timelines
* Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting
* Effectively identify and mitigate risks to Data Management deliverables
* Identify and resolve data handling related issues
* Provide a high level of expertise in data management to support clinical studies.
* Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status.
* Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock.
* Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding.
* Support the transfer, locking, and archiving of study databases. Manage scheduling and time constraints across multiple projects.
* Prepare recommendations for new or improved processes for data management and data flow.
* Work collaboratively with cross-functional stakeholders to ensure project deliverables and timelines are met.
* Direct and oversees activities of Data Management staff assigned to studies and tasks within projects
* Perform project level resource management in conjunction with CDM Management
* Lead electronic submission activities for Data Management as appropriate.
* Participate in selecting outsourcing partners for assigned studies including:
* Input to Request for Proposal (RFP)
* Review proposals
* Participate in evaluation/audits and capabilities presentations
* Review project scope of work documentation
* Provide oversight of vendors providing Data Management services
* Develop and execute study specific training of staff within a project
* Lead or participate in CDM process improvement initiatives
* Promote and be an advocate for CDM internally and externally.
* Direct the activities and hold accountable junior data managers and/or data review teams
SUPERVISORY RESPONSIBILITIES:
* No direct reports
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
* BS/BA degree in related discipline and a minimum of 11 years of related experience; or,
* MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
* PhD in related discipline and a minimum of 5 years of related experience; or,
* Equivalent combination of education and experience.
* May require certification in assigned area.
Experience/The Ideal for Successful Entry into Job:
* Typically requires a minimum of 9 years of related experience and/or combination of experience and education/training.
* A minimum of 7 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials.
* A minimum of 4 years in a project leadership role
* Experience with Electronic Data Capture (EDC) is required and experience with Interactive Voice or Web Response Systems (IVRS/IWRS) is preferred.
* Demonstrated experience leading data management teams is preferred
Knowledge/Skills:
* The ability to problem solve and have people/project leadership skills.
* Knowledge of GCP is essential.
* General knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDc) systems required
* Expertise in CDASH/CDISC standards preferred.
* Has extensive experience in relevant industry/profession and area of specialization.
* Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
* Identifies and implements methods and procedures to achieve results.
* Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
* Performs a variety of complicated tasks with a wide degree of creativity and latitude.
* Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
* Has good general knowledge of other related disciplines.
* Applies strong analytical and business communication skills.
* Demonstrated Data Management Project Management skills
* Excellent verbal and written communication skills and interpersonal skills are required.
JOB COMPLEXITY:
* Utilizes appropriate CDM concepts and resources to solve moderately complex technical CDM issues
* Works independently and consults with management on decisions affecting project delivery as appropriate
* Drives the completion of milestones associated with specific projects. Failure to achieve results or erroneous decisions or recommendations will cause delays in program schedules and may result in the allocation of additional resources.
* Regular inter-organizational and outside contacts on routine matters.
* Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
* Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
* Networks with key contacts outside own area of expertise
#LI-JD1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $160,000 - $226,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Brand Finance Manager
Chadds Ford, PA Job
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Reporting to the Head of US Commercial Finance supporting the Commercial Business and Medical Affairs functions within the US Business Unit, the Brand Finance Manager will be responsible for providing financial support to the US Oncology/Dermatology Business Units mainly through expense management including monthly closing, annual budgeting and quarterly forecasting related activities.
Essential Functions of the Job (Key responsibilities) • Work closely with Accounting Services group to ensure all Commercial/Medical Affairs accruals are reviewed for accuracy and completeness from Gappify accrual system.
• Improve accrual Gappify response rate from internal budget owners.
• Perform month-end close activities for certain commercial activities not handled by Accounting Services group.
• Review invoicing and related transactions generated by A/P to ensure proper accounting.
• Provide guidance to administrative assistants and project managers on proper treatment of requisitions.
(coding block, processing, approval, etc.
).
• Create and review departmental reports to compare actual expenses vs.
budget creating ad hoc reports in Hyperion and/or PeopleSoft to provide transparency and accountability of budgeted spend.
• Review expenditures in PeopleSoft to ensure proper accounting treatment.
Re-class entries and change PO to reflect proper coding when necessary.
• Note any large expenditures/outliers and prepare review with Head of US Commercial Finance, AVP FP&A and VP Finance and Chief Accounting Officer.
• Perform run rate analysis vs.
Budget / Forecast for all expenditures.
• Maintain the US Business Open PO Report file to track spending for all of US Business to manage commitments and coordination with Procurement to analyze category spend.
• Review project spend with Commercial and Medical Affairs team members including department heads.
• Develop Op-Ex dashboard reporting using Business Objects and roll out to stakeholders.
• Assist Head of US Commercial Finance and Senior Director, Finance of Dermatology Business Unit with Annual Budget presentation including development of slides to support the US Oncology/Dermatology Business Unit Budget presentations.
• Liaison with external auditors in supporting and understanding accruals, as required.
• Continuous Process Improvement - Assist in financial process improvement initiatives and develop metrics for measuring effectiveness and efficiency while meeting business needs.
• Understand the business drivers and make recommendations to teams around resource allocations.
• Ad hoc projects including sales, royalty reporting and support to the Corporate Strategic Plan.
• Individual will serve as critical customer facing/business partnering role.
Qualifications (Minimal acceptable level of education, work experience, and competency) • BS degree in finance-related field or equivalent.
• 5+ years of progressive, relevant work experience in financial planning, analysis, modeling and accounting.
• Strong analytical and problem solving skills to support budget owners and department heads.
• Strong organizational skills.
• Good communication and collaboration skills.
• SAP (or comparable ERP system) and Hyperion experience recommended.
• Demonstrated ability to work in a fast paced and complex 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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
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 here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.
Senior Director, Sales Operations
Chadds Ford, PA Job
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function) The Senior Director, Sales Operations (hiring level commensurate with skills and experience) is a senior leader within the US Commercial Operations team, reporting to the VP Commercial Operations.
This position is responsible for supporting all Incyte Field Sales teams across the current and future ONCOLOGY portfolio.
This position oversees the strategic development and execution of the incentive compensation plans, sales targeting development, call plan development/upkeep, field alignments, sales execution and performance reporting, metric identification, and field team effectiveness.
In addition, the Sr Director, Sales Operations is responsible for fleet management for all US Field-based roles (both DERM and ONC field sales, as well as vehicles for other field-based roles in Market Access, Medical Affairs, and Reimbursement).
This position will also develop appropriate educational content in collaboration with Product Strategy and Sales Training to address any ongoing analytical education and tactical execution opportunities.
Essential Functions of the Job (Key responsibilities) • Manage the Sales Operations team across all applicable therapeutics areas.
• Lead, manage, and develop direct reports in the execution of the core sales operations functions with a focus on collaboration across the Strategic Customer Engagement & AA team and US Business Unit.
• Assist in building roadmap and execution of team expansion, future state capabilities in advance of new therapeutic areas, and/or business development opportunities.
• Work closely with executive sales leaders to determine opportunities for increased field efficiencies, analytical education gaps, and coordinate with product strategy for implementation of new field tactics • Ongoing coordination with Multichannel Strategy team to support the multi-channel experience for field sales execution.
• Identify and build out appropriate educational materials to support ongoing representative and regional manager's development in the areas of business planning, sales analysis, and execution.
• Continually evaluate team structure to optimize resources and provide increased/consistent customer support.
• Lead any sales force sizing and structure projects for ongoing efficiency or new opportunity.
• Develop call plan and promotion response models if and when applicable for the field sales teams.
• Manage and direct sales data inquiry request/resolution for sales incentive compensation data, sales reporting, and CRM reporting.
• Manage alignment process of territories/regions to maximize effectiveness of the sales force, compliance measures for promotional activity, and IC plan equity.
• Support the creation, management of all IC operation activities including goal allocation, goal adjustments, validation of IC process and payout process, monthly reporting and analysis on impact and issues affecting field incentive plan.
• Responsible for the consulting, development, and management of the rewards and recognition programs, including Mighty Oak and field contests.
• Analyze sub-national performance trends & sales force effectiveness to identify opportunities and inefficiencies.
• Manage quality assurance in the tracking & implementation of field force targets and affiliations within the CRM system.
• Partner with sales management to define and produce or enhance reporting to measure sales force productivity and ensure effective implementation of established strategies and tactics.
• Work directly with cross-functional teams and vendors to coordinate & manage the deployment of all sales force reporting: data availability and Q/A process of sales reporting.
• Responsible for all field training in regards to field sales tools, i.
e.
dashboards, Incyte Mosaic, ad hoc reports.
• Co-responsible for development and alignment of field CRM platforms and master data managements capabilities (MDM) directly used by all field personnel.
Will need to have comprehensive knowledge of current CRM, reporting, and master data management (MDM) capabilities.
• Collaborate across the Strategic Customer Engagement & Advanced Analytics and Market Insights teams to develop key performance metrics and dashboards that help the sales organization focus on performance drivers.
• Oversee and provide solutions and reporting for field sampling programs.
Work with compliance to ensure PDMA compliant sampling practices and federal reporting requirements are fulfilled.
• Manage Incyte Field Fleet program across North America.
Manage program in accordance with Incyte policies and focused on fiscal and environmental responsibilities.
• Develop communication materials to support field sales management on business reviews and sales force tools.
• Collaborate with the Business Information Services (BIS) team to define business requirements and solutions for all tools and deliverables that support the field sales force.
· Role also has direct responsibility for supporting the review and approval of Field-based requests for Exhibits and Displays across the country.
· Designs and manages Expense Report audit functions - assessing accuracy of Field Sales Expense Report submissions and issuing recommendations for remediation actions based on findings.
Qualifications (Minimal acceptable level of education, work experience, and competency) • BA or BS degree required, degrees in mathematical background preferred.
• 8-10 years leading diverse Sales Operations functional areas in the Pharma/BioTech industry.
• Detailed understanding of sales processes, sales data tracking, sales force automation, incentive compensation design and operations, promotional response concepts, and sales force alignments.
· Extensive experience in the design, adaptation, and communication of multiple incentive compensation plans including the enrollment of senior organizational and field-sales leaders.
• Experience in managing and developing direct reports.
Proven experience in motivating high performance teams and versed in techniques for effective coaching, communication, and working styles.
• Proficient in all aspects of analyzing healthcare sales data and field force activities.
• Proficient in customer relationship management systems, i.
e.
Sales Force.
com.
• Excellent verbal, written and stakeholder management skills to effectively influence and manage expectations with sales management and cross-functional teams.
• Strong project management and extensive data processing and analytics technical 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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
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 here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.
Data Analytics Manager
Chadds Ford, PA Job
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
The Data Analytics Manager is a data analytics technical expert with strong leadership skills.
This role will lead projects, manage development teams of contractors, and engage business / IT stakeholders to ensure success.
Essential Functions of the Job (Key responsibilities) · Accountable for end-to-end delivery of data analytics solutions using Microsoft Fabric + Power BI.
· Design technical solutions based on business requirements in alignment with IT architecture standards and processes.
· Design relational models developing semantic relationships between tables and entities based on requirement gathering and interaction with stakeholders.
· Convert business requirements and problem statements into actionable code delivering ETL/ ELT data transformation, using notebook-based development using PySpark.
· Work closely with group of developers and data engineers to develop, troubleshoot and validate code, models and PowerBI data products.
· Lead technical project delivery teams consisting of data / BI engineers including assigning work, tracking progress, and providing technical guidance.
· Engage and manage business and IT stakeholders throughout the requirements gathering, delivery, and testing process.
· Negotiate project scope, cost, timeline, and changes with business and IT stakeholders.
· Take functional ownership of a specific business area (e.
g.
Clinical, Corporate Functions, etc).
· Identify and lead continuous improvement activities related to new technologies and business process within Data Products & Analytics department Qualifications (Minimal acceptable level of education, work experience, and competency) · High School Diploma required: Bachelor's Degree preferred.
· Technical expertise in both Power BI and cloud Data Lake / Lakehouse technology (Microsoft Fabric is preferred, but Databricks or equivalent will be considered).
· Strong experience designing data models in the context of a data lake platform, including the implementation of medallion architecture.
· Coding proficiency in PySpark and experience with Git based version control and CI/CD.
· Experience with delivering projects in adherence with IT and team standards.
Experience designing and implementing design standards is a plus.
· Experience leading data analytics projects and technical teams.
Direct people management experience is a plus.
· Experience engaging with business and IT stakeholders.
· Relevant subject matter expertise in relevant business areas (e.
g.
Clinical Trials, Clinical Operations, Technical Operations) and source system types (e.
g.
SAP, Veeva, CTMS, PPM) 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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
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 here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.
Assoc. Director to Director, Market Access Marketing
Chadds Ford, PA Job
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function) This position is responsible for the strategic development, cross-functional integration, and executional excellence of US Market Access plans for current and/or pipeline products and indications within the Incyte portfolio.
This is a headquarter based role in Chadds Ford, PA requiring 4 days in the office.
Essential Functions of the Job (Key responsibilities) Develop and execute integrated market access brand plan(s), annual operational plan and new product/indication launch planning activities Develop, implement and pull-through branded and unbranded market access promotional plan and educational activities; including planning, resource creation, and implementation across payer, IDN, VA, DoD and emerging organizations (e.
g.
, ACOs).
Develop and plan for associated market access team training initiatives Collaborate with Product Strategy and across Market Access functions to ensure appropriate alignment and integration of strategy Collaborate in the development, implementation and placement of personal and non-personal print, digital media and video promotional plans and associated resources Collaborate with Product Strategy, Market Access functional leads, and Payer Account teams to identify and develop content for market access marketing programs Collaborate with Payer Account Team Lead in the monitoring of payer formulary and policy access Provide marketing input to HEOR studies and translate findings into promotable resources Plan and execute advisory boards and engagement activities with external experts to gather insights and inform strategy Design and implement qualitative and quantitative Market Access market research to inform strategy and implementation Collaborate with Medical, Legal, Regulatory, and Compliance colleagues to gain approval of educational and promotional resources Collaborate with Global Value and Access team, as needed Work with multiple external agencies to manage projects from concept to completion on time and within budget; while measuring success vs industry benchmarks and ensuring strategic alignment and executional excellence Manage annual budget, POs, invoice approvals, and monthly accruals and projections Develop and deliver internal and external presentations to support the US Market Access Team Work in a fast-paced environment, rapidly assimilate information, make decisions, prioritize and manage multiple projects/priorities Qualifications (Minimal acceptable level of education, work experience, and competency) Minimum of 7 years-experience in the pharmaceutical/biotech industry Minimum of 2 years-experience in brand marketing, or market access marketing Oncology experience required; with oral and IV agents preferred including knowledge of oncology GPOs and large, organized hospital and community oncology customers preferred Experience with launching products preferred Strong project management, agency and budget management experience Strategic and innovative mindset with attention to detail Demonstrated ability to work effectively with cross-functional stakeholders Experience working within appropriate compliance, medical, legal and regulatory environments (i.
e.
, promotional review processes, fair market value, Sunshine Act, HIPPA, etc.
) Demonstrated knowledge of MSOffice Suite.
Experience working within regulatory/compliance, systems/technology preferred (i.
e.
Fair Market Value systems, Veeva, Mobile Locker, CRM, SharePoint, WebEx, audio/video/projection, etc.
) Executive presence with strong verbal/written communication and interpersonal skills Knowledge of payer marketing, managed care, state and federal reimbursement sectors 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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
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 here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.
Associate Clinical Science Director
King of Prussia, PA Job
SUMMARY/JOB PURPOSE: In collaboration with clinical and project teams of the company, the Associate Clinical Science Director designs, plans and develops clinical evaluation research studies in oncology with focus on solid tumors. This position may assist in or prepare and author clinical development related documents including study synopses and protocols. Summarizes study results for preparation of documents and publications. Supports project teams with scientific information and provides progress updates related to the assigned clinical studies. Must have experience with clinical studies in oncology.
Essential Duties And Responsibilities:
* In collaboration with the clinical teams for a specific product candidate, designs, prepares and initiates study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
* Conducts appropriate literature research for the assigned clinical product candidate.
* Works with medical monitor to enable interaction with clinical sites and thought leaders in oncology to assist sites in efficient completion of clinical trials
* Collaborates with clinical operations and other internal study team members to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
* Collaborates with clinical operations and other team members in the development of agendas, training materials, and presentation for site visits, investigator meetings, and other study related venues
* Participates in internal safety meetings, analyzes, and reports potential safety events in coordination with medical monitor.
* Collaborates with team members in clinical review and interpretation of study data in support for preparation of reports for health authorities including regulatory filing documentation and study close-out reports.
* Helps to write and/or review product specific abstracts, publications, and supports the development of presentations for scientific meetings.
* Proactively provides feedback on emerging clinical and competitive trends.
* Delivers high quality scientific presentations on Exelixis investigational agents to physicians and other key external customers.
* Maintains clinical and technical expertise in the therapeutic area of Oncology.
Supervisory Responsibilities:
* None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
* Pharm.D., PhD, or M.D. or equivalent education and a minimum of five years of related experience.
* Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
* Three to Five years of clinical development experience in the biotechnology or pharmaceutical industry or a combination of academia and industry.
* Participated in clinical oncology studies with molecular targeted or immunological therapies.
Knowledge/Skills:
* Detailed knowledge of clinical trial implementation and drug development process.
* General knowledge of other related disciplines in the execution of clinical trials.
* Identifies and implements methods and procedures to achieve results with high quality.
* Performs a variety of complicated tasks with a wide degree of creativity and latitude.
* Has understanding and wide application of technical principles, theories, concepts, and techniques.
* Applies strong analytical and business communication skills.
* Highly organized and able to work under tight timelines
* Good public speaking and presentation skills
JOB COMPLEXITY:
* Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
* Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation of criteria for obtaining results.
* Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
* Networks with key contacts outside own area of expertise.
Working Conditions:
* 10-25% travel requirement.
#LI-JD1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $158,000 - $224,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Product Strategy Operations Manager
Chadds Ford, PA Job
Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function): The Manager, Product Strategy Operations leads the day-to-day operational and logistical related activities for the execution of Congress Meetings, Speaker Bureau and Multi-Channel Engagement programs across the Oncology / Hematology portfolio.
This role sits on the Product Strategy team and will lead and cross-functionally partner with the individual brand teams to ensure activities are aligned and supported, across the above areas, to ensure support of the overall portfolio strategy.
This role will manage third-party vendor partner relationships to ensure superior execution, along with policy and compliance adherence.
This is a highly collaborative position, where decisions will be made in a team environment, involving key stakeholders from internal departments and external partners.
This position requires extensive contact with stakeholders to secure meeting requirements, communicate effectively to logistics vendors and other third-party vendors; and ensure excellence in operations, on-site execution, and financial reconciliation.
This role is responsible for the management and reconciliation of the convention, speaker bureau logistics and multi-channel engagement implementation budget.
This position requires 4 days in the office and allows for 1 day remote per week.
Essential Functions of the Job (Key responsibilities): Cross Brand Convention Activities: • Operational management and ensuring cross brand alignment on all exhibit-related tasks • Work across brand teams to understand and incorporate key brand objectives into convention strategy, booth design and booth experience • Secure appropriate convention presence, exhibit space and advertising opportunities based on brand need • Association point of contact and management • Liaise with operations convention lead and exhibit hours and logistic vendors when required • Cross brand project management and brand advisor for all convention related activities • Maintain and update conventions plan and roles and responsibilities across brand team • Budget and reconciliation, relative to conventions • Manage all communication aspects of respective meetings or conventions to internal attendees, including coordination of various departmental attendees, field sales force, brand team members, and senior management, as appropriate.
Cross Brand Speaker Bureau Operations Activities: • Operational management of all speaker bureau related tasks including, annual speaker training planning, speaker contracting, speaker management, speaker program exceptions and speaker program audits • Responsible for the management of third party vendors and associated operational tasks including, speaker nomination, renewal and contracting.
Management of annual speaker cap and aggregate spend and contract auditing.
• Development and approval of all materials related to the operations of the speaker bureau and speaker training meetings (i.
e.
invitations, confirmation letters, etc.
) for MLR review • Responsible for all operational aspects of live and virtual speaker training meetings and attend and present as appropriate for on operational content • Manage and update speaker Bureau SOPs as necessary • Collaborate with sales team, compliance and legal as appropriate for speaker bureau activities • Lead the monthly Speaker Bureau Committee meetings • Ensure appropriate communications to speakers of any relevant operational updates Cross Brand Multi-Channel Engagement (MCE) Operations: • Partner with the brand teams on the implementation of websites and email campaigns through Incytes CRM system • Partner with the MCE operations team to ensure appropriate timelines and implementation on email campaigns and websites based on business and brand objectives.
Qualifications (Minimal acceptable level of education, work experience, and competency): Experience in pharmaceutical or biotechnology product marketing and/or marketing operations Ability to collaborate closely with internal and external/agencies partners Strong leadership skills and ability to manage multiple priorities and complexity.
Strong communication, presentation, analytic and strategic capabilities.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: ***********
incyte.
com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
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 here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.
You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here.
By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.
com if you have any questions or concerns or would like to exercise your rights.