Iovance Biotherapeutics jobs - 52 jobs

The Quality Assurance Specialist I, Document Control is located at Iovance Cell Therapy Center (iCTC) in Philadelphia, PA. This position requires full-time on-site presence. This position is responsible for supporting the Quality Document Control program at the iCTC facility and ensuring compliance to quality objectives and regulatory standards. The individual must have a strong quality mindset. Shift: Sunday to Wednesday from 9am to 8pm Essential Functions and Responsibilities * Responsible for issuance of unique identifier/lot number for identification and traceability of Patient and Non-Patient Manufacturing Lots. * Performs the issuance of Patient and Non-Patient batch records and required forms. * Generates and issues in-process labels for both Patient and Non-Patient Lots. * Supports the day-to-day need of Manufacturing, QC, and other departments at iCTC. * Must be proficient in Associate Level responsibilities to serve as a back-up, as needed. This includes logbooks and controlled copy issuance, and archival. * Independently manage, process, review, and approve the archival of documents in the Electronic Document Management System (eDMS). * Provide user assistance on eDMS * Responsible for problem solving related to job responsibilities. * Provides support for internal and regulatory audits and inspections as required. * Assists with maintaining Quality Assurance Document Control tracking tools for metric purposes. * Provides continuous feedback on improvements to Document Control processes. * Escalates issues or concerns to Area Management * Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics. * Perform miscellaneous duties required to complete the responsibilities stated in this Job Description (i.e. maintaining inventory of supplies and purchasing, maintaining the work area tidy, attend meetings, etc.). * Perform other duties assigned by the area management, which may or may not be associated with projects. Travel - none required Preferred Education, Skills, and Knowledge Bachelor's degree in Life Sciences discipline is required. * Minimum of two (2) years of experience in document change management and archival or advanced degree without experience. * Minimum of two (2) years of experience in cGMP, FDA regulated industry is required. * Strong computer skills including MS Office Suite * Must possess a high level of attention to details and have a strong quality mindset. * Must be organized * Must be qualified, highly motivated, and a team player. * Ability to work effectively on multiple projects simultaneously with minimum supervision. * Strong interpersonal and communication skills 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 remain in a stationary position standing or sitting for prolonged periods of time. * Able to crouch, bend, twist, reach, and perform activities with repetitive motions. * Able to stand and/or walk in a 10-hr day which may include climbing ladders or steps. * Must be able to move about inside an office and exert up to 30 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. * Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, safety glasses, etc. * Must comply with Safety SOPs and laboratory procedures per the company policy. * Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. * This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. * Must be able to communicate with others to exchange information. 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 job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards. #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.

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR‑T cell therapies have changed the paradigm, but we're not finished yet. Join Kite and help shape where our business and medical science goes next. You'll play a key role in the development of new cancer therapies and in creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Job Description We are seeking a highly motivated individual to join us as the Associate Director of Marketing focused on the LBCL indication. The Associate Director will play an important role in developing HCP promotion, cultivating an integrated LBCL strategy, and implementing a cross‑functional tactical plan to support and grow Yescarta's LBCL indication. This person will report to the head of LBCL within Kite's US Commercial Department. Key Responsibilities of the Associate Director of Marketing - Yescarta include: Develop and optimize brand strategies and marketing tactics using market research and analytics, ensuring accurate փmeasurement of promotional tactics. Oversee the development and execution of annual brand plans, including long‑term strategic imperatives and short‑term tactical priorities. Champion cross‑functional alignment and ensure seamless execution across key stakeholders. Develop and deliver differentiated brand and marketing concepts and materials, aligning with the brand's purpose, target customer needs, and industry trends. Collaborate with the Promotional Review Committee (PRC) to create compliant and effective promotional tactics and ensure their effective implementation. Formulate, develop, and implement strategic plans while escalating market challenges and barriers to leadership, proposing appropriate solutions. Exhibit a “roll up your sleeves” attitude, demonstrating the ability to follow through on projects within tight timelines. Adapt and thrive in an ambiguous, transformational environment. Demonstrate leadership excellence in project management, effectively managing multiple projects and priorities, including agency collaboration and budget management. Travel domestically up to 50%. Basic Qualifications Advanced degree (PharmD, PhD, or equivalent) with 5+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR Master's Degree知 2+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR Bachelor's degree with 10+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR Associate Degree and 12+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing OR High Schoolandaş Diploma/GED and 14+ years of relevant experience in strategy consulting, pharmaceutical marketing, or biotechnology marketing. Preferred Qualifications MBA or other advanced business degree. 8+ years of pharmaceutical or biotechnology experience. Experience in marketing research and / or pharmaceutical sales. Prior hematology / oncology or cell therapy experience, with in‑depth knowledge and experience in franchise‑specific market preferred. Ability to leverage data to conduct analyses and use complex analytical tools to drive decisions. Demonstrated excellence in project management and effectively managing multiple projects / priorities. Ability to successfully work with external agencies, including advertising, public relations and medical education vendors to develop programs and materials. Familiarity with marketing fundamentals, strategy, sales and commercial policies and practices. Compensation & Benefits The salary range for this position is: $177,905.00 心 $230,230.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligibleеспублик for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Equal Employment Opportunity Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual yenye orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the влияет-era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. Location & Remote Work Job Level: Associate Director Remote Type: Onsite Required Job Type: Full‑time Location: Santa Monica, CA #J-18808-Ljbffr

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 Exec. Director, Oncology Training & Development is responsible for establishing and executing the strategic vision for all Sales, Marketing, and Market Access training initiatives within the Oncology business unit. This leader will design, deliver, and manage comprehensive training programs to ensure the commercial organization is equipped with the knowledge, skills, and resources necessary to excel in a dynamic oncology market. The role oversees the development and implementation of training curricula for new product launches, ongoing product education, and leadership development, ensuring alignment with organizational goals and compliance standards. Responsibilities: * Develop and implement the overall training strategy for Oncology Sales, Marketing, and Market Access ensuring alignment with business objectives and market evolution. * Design, deliver, and manage all aspects of the Oncology Sales, Marketing, and Market Access and Business Operations training curriculum, including new hire onboarding, product launches, disease state education, and ongoing professional and leadership development. * Partner with Incyte's Director, Employee Development on enterprise-wide development initiatives. * Hire, lead, and develop a high-performing training team responsible for the creation and delivery of training programs. * Partner with Medical, Legal, Regulatory, and Commercial teams to ensure all training materials are accurate, compliant, and up-to-date. * Establish and maintain the LMS to roll out, track, and report on all training activities for the Oncology commercial organization. * Oversee the training budget, optimizing the use of internal and external resources to maximize impact and efficiency. * Regularly assess training effectiveness and implement improvements based on feedback, business needs, and market changes. * Develop and deliver programs focused on both sales effectiveness and leadership capabilities within the Oncology commercial team. * Ensure all training content reflects the latest developments in oncology, including key brands and emerging products. * Submit all training materials through the Medical, Legal, and Regulatory (MLR) review process to ensure compliance with industry standards. Qualifications: * Bachelor's degree required; advanced degree or relevant certifications preferred. * Significant years' experience in leadership development, talent management, or organizational effectiveness * Extensive experience in pharmaceutical/biotechnology industry, with a strong preference for oncology/hematology market knowledge. * Proven track record in Sales and/or Marketing training and development, including leadership roles. * Experience with adult learning principles, instructional design, and e-learning technologies. * Strong organizational, communication, and leadership skills. * Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel, Access). * Ability to manage multiple projects and priorities in a fast-paced environment. * Demonstrated ability to collaborate cross-functionally and influence without authority. * Willingness and ability to travel (15-20%) 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: 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 if you have any questions or concerns or would like to exercise your rights.

SUMMARY/JOB PURPOSE: The Senior Regional Director, MSLs is a manager-leader within the Medical Affairs department. Direct and indirect responsibilities include solid tumor oncology HCP engagement, investigator initiated studies, support of company sponsored trials, scientific congress support, development of MSL plans, and management of a regional MSL team as assigned. Essential Duties And Responsibilities: Responsible for providing direction, guidance, and support to a team of MSLs in an assigned region (6-8 MSL reports) Responsible for direct territory responsibilities in situations when no MSL coverage available Assessment, recognition, and improvement of MSL performance at the individual and group level Ensure the successful execution of MSL strategic, operational, and tactical plans Keep the executive director of MSLs informed about key information in a timely manner Represent Exelixis Medical Affairs as managers in the field Represent Medical Affairs management as a cross-functional partner within the company Serve as a positive role model and actively support the professional development of reports With guidance from the executive director of MSLs, regional directors are expected to lead high visibility Medical Affairs projects and be accountable for the outcomes Foster teamwork and continuity across the entire MSL organization Engage key national and regional thought leaders and healthcare professionals In an accurate, fair and balanced manner, exchange scientific information with external parties Report field intelligence to Exelixis including competitive information, perspectives about compounds, and the treatment landscape Represent Exelixis management at medical conferences and provide session summaries Within guidelines, provide cross-functional support across the company by being a scientific resource Develop and maintain a level of knowledge about pertinent studies, compounds, and diseases that would facilitate collegiate and scientific discussions with leading oncology thought leaders Consistently demonstrate a high standard of excellence and require the same from reports Ability to support the achievement of individual, functional, and departmental goals while executing all duties in an honest and compliant manner Supervisory Responsibilities: Directly supervises employees EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Master's level oncology PA or NP degree with active commitment towards completion of doctorate degree preferred and a minimum of 13 years of related experience; or, Accredited doctorate degree in a basic-science or life-science discipline (Pharm.D., Ph.D., D.Sc., D.N.P., or D.O.) and a minimum of 12 years of related experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: A minimum of 6 years of experience in pharmaceutical industry preferred Oncology MSL management experience preferred A minimum of 8 years as an MSL in therapeutic oncology preferred Prior experience as a people-manager of similarly credentialed and skilled reports. If no prior MSL management experience, mentorship from a prior manager in preparation for a management position. Knowledge/Skills: Ability to manage multiple projects in an efficient and effective manner Completion of leadership training coursework Ability to take and follow directions, accept guidance, and adjust quickly to changes Ability to communicate and engage small and large groups in an engaging manner Ability to efficiently manage time and priorities Ability to demonstrate leadership while recognizing when input from others is needed Working Conditions: Ability to travel frequently (50% or more); including occasional weekends #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 $270,000 - $345,000 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.

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 Manager/Sr. Manager, BIS, Business Intelligence - Market Access, part of Dermatology Business Operations, delivers dashboard and reporting solutions in support of key business objectives with a primary focus on market access business initiatives. Reporting to the Associate Director, Business Information Services - Market Access, this role is a key member of a larger team responsible for providing integrated technology solutions across CRM, Business Intelligence (BI), data platforms, and other critical commercial systems. Essential Functions of the Job (Key responsibilities) Serve as lead technical partner to Dermatology Business Unit stakeholders as it relates to business intelligence (BI) solutions such as dashboards and reporting. Lead end-to-end development dashboards/reporting solutions including taking an active role in eliciting, documenting, designing, building, and testing BI and products in support of key customers and business initiatives. Drive BI product development through user experience and interface design, prototyping, development, and continuous improvement. Manage third party vendors through development, testing and support of BI applications. Support Commercial Market Access and Market Access Operations, Product Strategy, Medical Affairs, Finance, Compliance and liaise with Incyte IT as projects or requirements dictate. Manage and maintain source files, data sources, and internal and external data exchanges in support of the US Business Unit. Daily involvement and understanding of data integration and business-rule processing related to Incyte's Master Data Management and Data Warehousing systems. Develop operational procedures and oversee successful execution of data flows and report refreshes to ensure timely, accurate delivery of dashboards to stakeholders Qualifications (Minimal acceptable level of education, work experience, and competency) Bachelor's degree required. Experienced Business Intelligence developer with 5+ years of BI reporting experience. Strong skills with at least one of the major BI tools (Power BI, Qlik, Tableau, etc), Power BI experience preferred. Experience working with pharmaceutical data sets such as IQVIA Xponent data, CRM and Multi-channel engagement data 3 - 5 years of pharmaceutical experience required. Proven ability to work with stakeholders to extract, articulate, and document report requirements. Proven ability to manage third party vendors and internal partners to ensure projects are completed on-time and on-budget. Intermediate level technical understanding of the data warehousing processing specific to the NA Business Unit. Strong sense of customer service; ability to interact with employees spanning all levels of the organization. Expert in Microsoft Office applications (Excel, Access, Word, PowerPoint). Functional knowledge of databases and SQL required. Knowledge of Azure data factories, Databricks, and Synapse Analytics preferred. Excellent organizational skills, written and oral communications. Proven ability to multi-task. Demonstrated ability to manage and/or actively participate in multiple simultaneous projects. 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: 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 if you have any questions or concerns or would like to exercise your rights.

The Senior Manager, Environment, Health & Safety role is responsible for providing compliant EHS programs to all departments at the IOVA-A facility. Integrates EHS programs into daily operations to assure regulatory compliance, achieves continuous performance improvement, meeting EHS performance objectives. Partners with operations to develop objectives to achieve these goals in alignment with site business goals and values. Provides technical leadership to ensures the biological safety programs adhere to federal, state, and local EHS regulations. Manages the day-to-day requirements and activities of the EHS incident management and reporting system. Essential Functions and Responsibilities * Serves as the site subject matter expert regarding general safety, chemical hygiene, biosafety (BSL 2), and environmental management. * Implements new and improves existing EHS programs to ensure compliance with federal, state, and local environmental, safety, medical surveillance and sustainability laws, regulations, codes, rules, and consensus standards. * Provides and executes programs, policies, procedures, and trainings as the site SME for high-risk work programs including but not limited to working from heights, electrical safety, hot work, confined space entry, lockout tagout, and contractor safety. * Completes hazard assessments, coordinates IH monitoring, process hazard analysis, life safety reviews, incident investigations, environmental reports, and permit applications as needed. * Participates in and supports EHS operational and tier discussions, safety committees and teams, self-assessments, and audits. * Reviews processes, facilities, procedures, and management of change documents to assure conformance to recognized EHS regulations, standards, and guidelines. * Provides support to staff in completing injury/illness investigations, additional training, data analysis, and addresses specific concerns as they are raised. * Participates in regulatory inspections and assists in addressing noted concerns and citations. * Reviews site data for the EHS reporting system (Enablon); manages user permissions; identifies data gaps and other concerns; generates output reports and dashboards using the appropriate BI tools; tracks and communicates EHS score card metrics. * Perform miscellaneous duties as assigned. Travel * May require up to 5% domestic travel. Required Education, Skills, and Knowledge * Bachelor's degree in Occupational Safety, Industrial Hygiene, Chemical Engineering, Process Safety Management, or a related technical discipline required. * Minimum 8 years relevant EHS work experience required. * Technical working knowledge of federal, state, and local regulations as well as CDC, NIH, BMBL guidelines, and other regulations and consensus standards required. Preferred Education, Skills, and Knowledge * RBP, CBSP, CIH, and/or CSP certification preferred. * Working knowledge of six-sigma and operational excellence a plus. * Experience with GMP environments and biotechnology processes preferred. * Demonstrated ability to quickly interpret complex regulatory issues and provide recommended course of action. * Strong written and verbal communication skills with the ability to communicate clearly to all levels of the organization. * Self-motivated, flexible, creative, able to prioritize, and work in a fast-paced, dynamic environment and effectively deal with conflicting and changing priorities. * Strong working knowledge of computers and programs including Microsoft Office, SharePoint, Teams, Enablon, etc. * Excellent interpersonal, relationship management, and organizational skills. 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. 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. 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.

The Maintenance Technician II is responsible for the maintenance and repair of equipment, utilities and systems supporting cGMP Manufacturing, Laboratories, Warehouse and commercial office space. Perform planned and corrective maintenance 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: 3rd Shift Schedule: Wednesday to Saturday from 10pm to 9am. Essential Functions and Responsibilities * Demonstrate a strong understanding of HVAC, mechanical, electrical and process utilities systems, and be able to troubleshoot and repair. * Perform repairs/installations/upgrades to building components, including plumbing, electrical, HVAC, carpentry, painting, furniture, flooring and any other general repairs as necessary. * 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) * Responsible for installing/reconfiguring furniture, chairs and associated equipment, and coordinate/assist with personnel moves within the facility. * Accountable for the safety of all personnel and equipment within the facility. * Monitor and respond to alarms generated from the BMS/QEMS, including on-call. * Work with management to develop spare parts plans and ensure adequate inventory is maintained and tracked to support the maintenance and operation of the facility and equipment. * Receive, filter and execute work order requests as necessary. * Ensure that any equipment repairs or maintenance activities are compliant with any applicable building codes. * Maintains records on equipment manufacturers' technical notices, upgrades and safety issues. * Establishes programs and solutions for increasing up-time and for equipment problems that affect the manufacturing process. * Work with external vendors for the service and/or repair of equipment. * Conduct routine inspections of premises and equipment. * Investigating problems and diagnosing and repairing faults. * 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. * Comply with cGMP procedures and policies. * Perform miscellaneous/ other duties as assigned. Required Education, Skills, and Knowledge * Associates Degree / Trade School / Technical Certification (HVAC/R, Electrical, Plumbing) or equivalent experience is required. * Requires a minimum of 4 - 6 years of related experience. * A Philadelphia Engineer Grade A License is required or ability to obtain within 6 months to 1 year. * A strong background in operations and maintenance of chiller/boiler plants, pumps and AHU's is required. * A strong background in operations and maintenance of electrical systems, including Emergency Generators, ATS's and Switchgear 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. * Excellent oral and written communication skills required. * Must have valid driver's license Preferred Education, Skills, and Knowledge * 4-6 years of related Facilities and Maintenance experience preferred. * Prior experience in cell therapy manufacturing or BioPharma/Life Sciences is highly desirable. * Boiler license and/ or knowledge of boiler operations. 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 8-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 50 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 office, manufacturing, and lab settings. * When in the lab/ manufacturing space, must be able to work in settings 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.

The Shipping Logistics Specialist is responsible for the preparation, routing, and management of internal shipments derived from the Iovance Cell Therapy Center (iCTC) located in Navy Yard, PA and from Research and Product Development entities within the business unit as well as external shipments originating through affiliates associated with Iovance Biotherapeutics, Inc. The Shipping Logistics Specialist duties include reviewing shipment materials before distribution, collaborating with transportation systems to ensure prompt and accurate shipment pick-ups and deliveries, and monitoring shipment costs and productivity processes. Tuesday to Saturday - 8 hour day shift Essential Functions and Responsibilities: * Assist with the planning and scheduling of shipments including documentation, physical preparation of packaging, pick-up and delivery arrangements, routing information, shipping instructions, and customs clearance procedures (if applicable) to ensure deliveries arrive on time and to their correct location, using a variety of transportation methods such as trucking companies, railroads, airlines, and/or shipping lines. * Track goods in real time while enroute to their destination ensuring any problems that arise are resolved immediately to avoid potential delays; communicate issues to management that may hinder on time deliveries. * Serve as primary point of contact for external Supply Chain Logistics team when handling inbound and outbound patient samples, tumors, and final product out of iCTC; ensure documentation, pick-up and delivery arrangements are scheduled and communicated to appropriate personnel involved in the shipment. * Participate in the selection of best suited products or materials to estimate quantities or weight of shipments and type of container required for compliant storage and transport. * Liaise with Finance for the preparation of invoices ensuring shipping costs are calculated accurately and passed onto respective departmental cost center. * Negotiate rates with carriers and insurance agencies, and prepare tariffs for oversea shipments, ensuring approved budget targets are achieved as directed by the company. * Interact with insurance companies to settle claims for damaged or lost items. * Maintain a shipment database such as goods shipped, addresses, contact information, courier used, transportation method, shipment results, etc. that supports optimization efforts on future shipments. * Create reports for senior management on various shipping metrics such as tracking shipments and costs, compile statistics about shipping volume and rates, monitor courier performance, and participate in continuous improvement opportunities with recommendations to enhance shipping efficacy and accuracy, while lowering costs. * Performs other duties as assigned by leader. Required Education, Skills, and Knowledge * 5+ years warehouse experience in a high-volume cGMP production or manufacturing environment. * Working knowledge of MRP/ERP systems, APICS Certification is an asset. * Proficient in MS Word, Excel, Outlook. * Experience and/or certification in operating material handling equipment preferred (i.e. forklift). * Ability to collaborate across disciplines. * Strong interpersonal and team-building skills, effective communication (both written and verbal), proactive problem-solving and analytical skills. * Possess the ability to bridge relationships between various departments, levels of the organization, supplier and customer organizations. * Excellent organization skills and an ability to prioritize effectively to deliver results within reasonably established guidelines. * Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities with a strong attention to detail. * Willingness to work flexible hours, including overtime and weekends. Preferred Education, Skills, and Knowledge * Experience with cell 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 lab and clean room attire as well as all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc. * Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps. * Must be able to use near vision to view samples at close range. * 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 deadlines. Work Environment: This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. #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.

The Senior Clinical Data Manager is responsible for performing end to end Data Management activities. Participates as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager must have a broad, fundamental knowledge of the data management process and should be able to perform most required tasks with minimal guidance. Ideal candidate must live in the US permanently. Essential Functions and Responsibilities Leads a large clinical study or a series of related studies with minimal guidance. Represents Data Management at study management team meetings. Provides mentoring and training to lower-level Data Management staff assigned to his/her studies Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts. Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design. Performs a thoroughly detailed review of eCRF data requirements and create one if need be. Interacts with CRAs, programmers, study operations lead and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines. Leads the development of data edit check specifications and data listings. Coordinates the design and testing of Electronic Data Capture (EDC) systems according to company processes. Resolves EDC system issues with team members. Develops or lead the development of the Data Management Plan for a clinical study. Reviews and provides feedback to the clinical team on other study documents Statistical analysis plans and vendor specifications. Provides training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed. Performs reconciliation of data from external data sources against the clinical database. Performs Serious Adverse Event reconciliation activities according to SOPs and guidelines. Leads database upgrades/migrations including performing User Acceptance Testing. Performs database lock and freeze activities per company SOPs. Adheres to Iovance Biotherapeutics' core values, policies, procedures, and business ethics. Performs miscellaneous duties as assigned. Required Education, Skills, and Knowledge Bachelor's Degree or equivalent experience required in the scientific/healthcare field with a minimum of 8 years of experience. Must have good project management skills and a proven ability to multitask. Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice. Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Possesses strong English language written and verbal communication skills. Experience in working with oncology studies is a must. Able to travel to off-site meetings or training seminars as needed. Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable. 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 remain in a stationary position standing or sitting for prolonged periods of time. Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. Must be able to communicate with others to exchange information. 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 job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. #LI-remote 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.

The Inventory Control Specialist I is responsible for all aspects of inventory record keeping at the Iovance Cell Therapy Center (iCTC) located in Navy Yard, PA. They will keep detailed and accurate records of any changes in inventory or production and compile the consumption values into a database for trending and future analytical purposes. Eventually, modifications to ordering patterns may result from this exercise as it relates to changes in demand over time or changes in market supply availability. Essential Functions and Responsibilities: * Develop and implement procedures for balancing on hand inventory, demand and associated lead times to optimize inventory levels through various management programs such as Vendor Managed Inventory (VMI), KanBan systems, min/max leveling, off-site storage facilities, etc. * Participate in regular cycle counts and ad hoc inventory audits to ensure inventory integrity of >95% by verifying product identification, location and quantities with inventory management system * Research inventory discrepancies, reconcile within appropriate inventory management system when required and recommend preventive measures or process modifications to prevent future variances. * Ensure various storage depots located internally and externally are appropriately stocked to support business continuity, and when needed, supply additional materials to maintain established min/max levels. * Perform inventory data analysis using various models to identify opportunities, risks and trends around inventory consumption and make recommendations and/or offer tactical solutions to establish optimized safety stock levels while considering limitations associated with physical storage footprint and material expiries. * Monitor material status and effectively communicate low inventory, obsolete or expired materials to the respective Buyer/Planner and facilitate inventory meetings to review aged inventory and necessary disposition. * Engage in necessary warehouse cleaning duties including but not limited to sweeping the warehouse and bulk storage, mopping, general cleaning and dusting of warehouse walls, door panels, racks, containers, etc., and transport trash to disposal areas. * Performs other duties as assigned by leader. Required Education, Skills, and Knowledge * 5+ years warehouse experience in a high-volume cGMP production or manufacturing environment. * Working knowledge of MRP/ERP systems, APICS Certification is an asset. * Proficient in MS Word, Excel, Outlook. * Experience and/or certification in operating material handling equipment preferred (i.e. forklift). * Ability to collaborate across disciplines. * Strong interpersonal and team-building skills, effective communication (both written and verbal), proactive problem-solving and analytical skills. * Possess the ability to bridge relationships between various departments, levels of the organization, supplier and customer organizations. * Excellent organization skills and an ability to prioritize effectively to deliver results within reasonably established guidelines. * Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities with a strong attention to detail. * Willingness to work flexible hours, including overtime and weekends. Preferred Education, Skills, and Knowledge * Experience with cell 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 lab and clean room attire as well as all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc. * Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps. * Must be able to use near vision to view samples at close range. * 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 deadlines. Work Environment: This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. #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.

The Associate Quality Control Specialist, Document Control is located at Iovance Cell Therapy Center (iCTC) in Philadelphia, PA. This position requires full-time on-site presence. This position is responsible for supporting the Quality Document Control program at the iCTC facility and ensuring compliance to quality objectives and regulatory standards. The individual must have a strong quality mindset. Shift: Wednesday to Saturday from 9am to 8pm. Essential Functions and Responsibilities * Responsible for issuance of logbooks, protocols, and any applicable controlled documents. * Maintains the archival of GMP Ensures all GMP documents are complete, well organized, controlled, filed and tracked accurately in trackers and Electronic Document Management System (eDMS), if applicable, and easily retrievable. * Independently manage, process, review, and approve the archival of documents in the eDMS. * Provides user assistance on eDMS * Provides support for internal and regulatory audits and inspections as required. * Responsible for basic problem solving related to job responsibilities. * Assists with maintaining Quality Assurance Document Control tracking tools for metric purposes. * Provides continuous feedback on improvements to Document Control processes. * Escalates issues or concerns to Area Management. * Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics. * Performs miscellaneous duties required to complete the responsibilities stated in this Job Description (i.e. maintaining inventory of supplies and purchasing, maintaining the work area tidy, etc.). * Perform other duties assigned by the area management, which may or may not be associated with projects. Based on business needs, training on document and label issuance for Manufacturing department and, cross-training and assisting other teams within Quality Assurance department may be required. Travel - none required Preferred Education, Skills, and Knowledge * Bachelor's degree in Life Sciences discipline is preferred, but not required. * Strong computer skills including MS Office Suite. * Experience in archival and document change management is preferred, but not required. * Must possess a high level of attention to details and have a strong quality mindset. * Must be organized * Familiarity with cGMP, FDA regulations is preferred, but not required. * Highly motivated and a team player. * Ability to work effectively on multiple projects simultaneously and able to follow procedures and instructions. * Strong interpersonal and communication skills. 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 remain in a stationary position standing or sitting for prolonged periods of time. * Able to crouch, bend, twist, reach, and perform activities with repetitive motions. * Able to stand and/or walk in a 10-hr day which may include climbing ladders or steps. * Must be able to move about inside an office and exert up to 30 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. * Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, safety glasses, etc. * Must comply with Safety SOPs and laboratory procedures per the company policy. * Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. * This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. * Must be able to communicate with others to exchange information. 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 job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards. #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.

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 Medical Information and Content Development Manager/Sr. Mgr. is responsible for providing accurate, timely, unbiased, and up-to-date medical information to internal and external customers. The position will be responsible for the creation and maintenance of written scientific content, including medical information response letters (MIRLs), frequently asked questions (FAQs), and product dossiers regarding Company marketed products, investigational compounds, and related disease states. The individual will also serve as the primary medical reviewer of promotional and sales training materials. The position will also be responsible for the development of US Medical Affairs scientific exchange materials for field-based US Medical Affairs staff, advisory board materials, medical congresses, and other relevant projects and programs. The position will report directly to the Executive Director, Medical Information and Content Development. Essential Functions of the Job (Key responsibilities): * Oversee, develop, and maintain written scientific information for use in responding to unsolicited customer requests; explore opportunities to leverage AI solutions. o Manage external vendors involved in scientific content development. * Creation of medical information standard response letters, product dossiers, and frequently asked question (FAQ) documents * Serve as an active member on cross-functional teams (e.g., promotional materials review committee, core medical team, scientific materials review committee). * Provide medical literature surveillance for Medical Affairs; communicate pertinent updates in a timely manner. * Support medical conference activities, including execution of pre- and post-conference deliverables, insights generation, and staffing of medical/scientific booth. * Collaborate with cross-functional partners (eg, Research & Development, Publications & Medical Communications); assist with development of scientific exchange materials for emerging therapeutic areas. * Develop and maintain expertise in relevant hematology and oncology therapeutic areas, including disease states, treatment landscape, and ongoing research strategies. * Assist Medical Information Leadership with key projects, as needed. * Comply with all guidelines, policies, legal, regulatory, and compliance requirements. Qualifications (Minimal acceptable level of education, work experience, and competency): * Healthcare Professional (PharmD, MD, RPh, PhD in related field) with 2-5 years' experience working in a Medical Information/Medical Affairs capacity for a pharmaceutical or medical device company, or equivalent clinical experience, is required. * Knowledge of FDA regulations regarding the dissemination of Medical Information, drug promotion, and adverse event and product quality complaint reporting, is required. * Experience creating scientific content, including medical information response letters and clinical slide presentations, is required. * Ability to query scientific literature (via PubMed, Embase, Scopus, etc.) and identify and summarize pertinent findings is required. * Excellent oral and written communication skills are required. * Excellent project management skills, including the ability to plan, prioritize, and execute multiple projects are required. * Experience in hematology/oncology is strongly preferred. * Approximately 15% travel commitments. 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: 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 if you have any questions or concerns or would like to exercise your rights.

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. The Senior Quality Control Analyst, Lab Technical Support-Analytical will support flow cytometry and potency method qualification/validation, method technical transfer, and product release testing at Iovance's integrated Cell Therapy Center (iCTC). This role requires hands-on laboratory experience in at least two (2) of the following areas: cell culture / maintenance and cell count determination (NC-200), cell-based potency methods utilizing various immunoassay platforms (ELISA, ELLA, etc.), and/or identity / characterization / potency methods using multicolor flow cytometry platforms. This position will support the onboarding of new, or updating of existing, methods for the QC analytical team for release testing of cell therapy products. You may be required to work occasional weekends and holidays to complete assigned work. Essential Functions and Responsibilities: * Collaborate effectively with the Iovance Analytical Development (AD) and Analytical Sciences and Technology (ASAT) departments to perform assay qualification, validation, and technical transfer of updated and new methods. * Act as subject matter expert (SME) and train laboratory personnel on new and revised methods. * As needed to support product release, perform GMP laboratory testing with minimal to no errors, while ensuring testing is completed and documented in compliance with all applicable procedures, standards, and GMP/GDP regulations. * Author, review, and approve technical documents including but not limited to protocols, reports, and SOPs. * Contribute ideas for process improvements and technology enhancements in the QC laboratories. * Support thorough GMP investigations for quality events (e.g. deviations, invalid assays, OOS). * Initiate and support quality documents such as deviations, laboratory investigations, CAPAs, and change controls. * Perform technical review of laboratory data and logbooks. * Support Health Authority inspections. * Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations. * Other responsibilities as assigned. Required Education, Skills, and Knowledge * Degree in Biology, Immunology, Microbiology, Molecular & Cell Biology, or related scientific field, with 8+ (Bachelor's), 6+ (Master's) or 3+ (Ph.D.) years of relevant experience. * Minimum of three (3) years of GMP experience in the pharmaceutical industry within Quality Control or related function (e.g. AD or ASAT). * Solid understanding, functional knowledge, and hands-on experience with two (2) or more of the following: multicolor flow cytometry, cell-based potency, or cell culture with cell enumeration (NC-200). * Experienced technical writer (e.g., technical reports, test methods, SOPs, protocols, deviations, CAPAs, change controls) * Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity. * Successfully interface with multi-disciplined teams. * Operate at a consistent and high level of efficiency, producing high quality and accurate results. * Extremely detail-oriented with strong technical laboratory skills. * High level of ownership and accountability. * Demonstrate sense of urgency; ability to recognize time sensitivity. * Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) * Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics. Preferred Education, Skills, and Knowledge * Experience with cell therapy products. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation. Physical Demands and Activities Required: * Must be able to wear appropriate lab and clean room attire as well as all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc. * Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps. * Must be able to use near vision to view samples at close range. * 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 deadlines. Work Environment: This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. #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.

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 Manager, Business Information Services - Digital Data Solutions, supports digital data, BI, and analytics for omnichannel marketing within Incyte's US Business Unit. This role drives design, integration, and delivery of data solutions for omnichannel functions. It partners with Digital Strategy & Operations to ensure seamless customer experience and enable program performance measurement. This position requires a hybrid schedule with three days onsite. Essential Functions of the Job (Key responsibilities) Support the implementation of HCP and Direct to Consumer (DTC) channel data integration solutions across digital platforms. Assist in building and maintaining data pipelines to ensure secure and efficient data flow between systems. Collaborate with internal and external teams to deliver digital data solutions aligned with business objectives. Translate business requirements into technical specifications for channel integration and reporting. Work with cross-functional teams across Oncology, Dermatology, IT, Compliance, and Business Operations. Work directly with external data vendors to manage data onboarding, integration, and exchange processes, ensuring alignment with pharmaceutical data standards, privacy regulations, and business needs. Utilize and support API-based data exchanges to enable secure, scalable, and reliable integration between internal systems and external platforms, ensuring interoperability and data integrity across the digital ecosystem. Coordinate with BIS Data Engineering to support data pipelines for omnichannel initiatives. Contribute to the expansion of Incyte's digital data infrastructure and analytics capabilities. Partner with Digital Strategy & Operations to support new omnichannel initiatives and ensure data reliability. Assist in defining project scope, technical requirements, and deliverables. Support documentation and validation of data integration points and services. Qualifications (Minimal acceptable level of education, work experience, and competency) Bachelor's degree in Computer Science, Information Systems, Engineering, or a comparable discipline is required. Preferred: 5-7 years of experience in the pharmaceutical or related industry, with hands-on experience in omnichannel data architecture and HCP/DTC data. 2-3 years of experience working with cloud-based data engineering tools and managing technical projects. Experience collaborating with external data vendors, including establishing secure data exchange protocols and ensuring compliance with pharmaceutical data standards and privacy regulations. Experience collaborating with offshore teams, including coordinating across time zones, managing deliverables, and ensuring alignment with internal technical and business objectives. Familiarity with integration technologies (APIs, ETL tools, middleware) and data warehousing. Experience with data analysis and reporting tools (SQL, Python, Tableau, Power BI). Effective communication and collaboration skills. Ability to manage multiple priorities in a fast-paced 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: 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 if you have any questions or concerns or would like to exercise your rights.

Iovance Biotherapeutics is seeking Senior Lab and Endpoint Support Analyst to help ensure seamless, compliant device management and operational support for our lab infrastructure. This role is vital to both maintaining GxP compliance and enabling efficient endpoint/device operations. The successful candidate will bridge desktop and lab operations under the guidance of our endpoint engineer and collaborate with cross‑functional teams. This individual will also serve as the on-site owner of lab device asset management for lab manufacturing. Essential Functions and Responsibilities * Provide hands‑on support for lab devices, instrumentation, and endpoint systems, ensuring operational readiness and compliance with GxP regulations. * Serve as on‑site presence for lab shifts: support troubleshooting, incident triage, preventive maintenance, and quick resolution of lab device issues. * Create and upkeep of SOPs, documentation, SOP adherence, and maintenance of device validation records for audit readiness. * Serve as the on-site SME of lab device asset management and all asset management on the lab manufacturing side, ensuring accurate tracking, lifecycle management, and audit readiness. * Be the escalation point for the Operational issue in the Lab and be able to come in work as need be to support the shift duties if needed * SME for Lab support team in configuration, deployment, patching, imaging, and lifecycle management of devices (laptops, desktops, lab PCs, specialized lab instruments). * Manage device integrations: collaborate with engineers to roll out validated device builds, ensure correct configurations, security settings, and endpoint compliance. * Collaborate with the desk side team to ensure that all devices and systems are up to date with the latest security patches, software updates, firmware, and best practices. * Partner with Endpoint Engineering and/or Automation teams to identify process improvements and help automate manual desktop/lab support tasks. * Own and manage Lab Print Services by overseeing configuration, operation, and support of Lab and manufacturing printing systems used across Iovance labs, ensuring accuracy, compliance and minimal downtime. * Train and mentor junior level support staff on lab device protocols and endpoint management best practices. * Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics * Perform miscellaneous IT duties as assigned. General Responsibilities: * Develop and maintain technical documentation, including knowledge base articles and SOPs * Collaborate cross-functionality with IT, Security, Infrastructure and Application teams on IT projects * Evaluate and recommend emerging technologies to improve end user experience * Share and help to implement continuous improvement ideas Required Education, Skills, and Knowledge * 8+ years of hands‑on IT support experience, especially with device endpoints (imaging, patching, builds) and lab device/instrument support. * Strong understanding of device management tools (MDM, Intune, SCCM, etc.) and experience ensuring endpoint security and configuration compliance. * Experience working in GxP / GMP / lab environments, understanding of regulatory requirements and validation documentation. * Knowledge of instrument connectivity, USB drivers, vendor software, lab network security. * Solid troubleshooting skills-hardware, software, networking-as applied to both typical desktops and specialized lab systems. * MS365 admin understanding and have a good understanding of Network concepts * Excellent communication skills, both written and verbal; ability to document configurations, incidents, and standard operating procedures. * Ability to work across shifts / flexible schedule to provide lab coverage. Preferred Education, Skills, and Knowledge * ITIL foundations * Demonstrated knowledge in both wired and wireless network technologies * Demonstrating excellent written, verbal and phone communications skills * Advanced troubleshooting and issue resolution skills. * Excellent communication, customer service, and interpersonal skills. * Ability to work independently and manage multiple priorities in a fast-paced environment. * Willing to work overtime and weekends when needed * Ability to make independent judgment calls to resolve urgent and critical matters * Can-do attitude, defaulting to "yes, we will figure out a way" * Automation or scripting experience (PowerShell, Bash, or similar) for device deployment or maintenance tasks. * Previous experience in biotech / manufacturing / lab operations. The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation. Physical Demands and Activities Required * Must be able to pass gowning requirements and be prepared to support in the cleanroom, gown required areas * Must be able to remain in a stationary position standing or sitting for prolonged periods of time. * Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly lift, carry, push, pull, or otherwise move objects. * Must have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading. * This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. * Must be able to communicate with others to exchange information. 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 job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible. Requires operating standard office equipment and keyboards. #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.

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 Director, Oncology Portfolio Training & Leadership Development is a player/coach role responsible for establishing and executing high-impact training programs across key oncology functions, including Market Access, Key Account Management (KAMs), Nurse Educators, and Marketing, while also driving leadership development initiatives that build future-ready talent. This hybrid role combines hands-on training delivery with strategic oversight, enabling cross-functional excellence and leadership capability in a complex and evolving oncology landscape. Responsibilities: · Training Strategy & Curriculum Development · Design, develop and execute a comprehensive training strategy that supports the unique needs of diverse functional teams, including a comprehensive leadership development roadmap, including high-potential programs, executive coaching, individual develop planning, and experiential learning aligned with organizational goals. · Onboarding & Continuous Learning · Oversee onboarding programs and ongoing development ensuring readiness for product launches, access challenges, and evolving market dynamics. · Stakeholder Engagement & Alignment · Partner with senior leaders to assess leadership and competency gaps, define success, and co-create training plans that drive performance. · Content Development & Delivery · Ensure development of high-impact training materials, workshops, simulations, and digital learning experiences using adult learning principles and oncology-specific case studies. Oversee quality and effective vendor management. · Metrics & Impact Assessment · Define success metrics, track training effectiveness, and continuously refine programs based on feedback, performance data, and business outcomes. · Shepherd training materials through the Medical, Legal, and Regulatory (MLR) review process to ensure compliance with industry standards. Qualifications: · Bachelor's degree required; advanced degree or relevant certifications preferred. · Significant experience in leadership development, talent management, or organizational effectiveness · Extensive experience in pharmaceutical/biotechnology industry, with a strong preference for oncology/hematology market knowledge. · Proven track record in Sales and/or Marketing training and development, including leadership roles. · Experience with adult learning principles, instructional design, and e-learning technologies. · Strong organizational, communication, and leadership skills. · Proficiency in Microsoft Office Suite (Word, PowerPoint, Excel, Access). · Ability to manage multiple projects and priorities in a fast-paced environment. · Demonstrated ability to collaborate cross-functionally and influence without authority. · Willingness and ability to travel (15-20%) 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.

The Quality Assurance Specialist I, Raw Material Release role will support review of documentation and support releasing of raw materials, components and manufacturing kits. Schedule and Hours: Sunday to Wednesday from 7am-6pm. Essential Functions and Responsibilities: * Ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management. * Review of documentation associated with Raw materials, components in support of manufacturing operations * Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition, as required. * Review of deviations as assigned. * Revision of documents as assigned. * Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies, and observations to management. * Disposition incoming materials. * Preparing supporting documentation for release of materials. * Issuance of labels, as required. * Support lot closure * Other projects as assigned. Required Education, Skills, and Knowledge * A Bachelor's Degree in Science, Engineering, or a related technical discipline with at least 2 years of experience in a regulated industry or an advanced degree without experience. * Prior experience in cell and gene therapy preferred. * Working knowledge of cGMP regulations. * Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint. * Attention to detail. * Knowledge of QMS systems is a plus. 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 remain in a stationary position standing or sitting for prolonged periods of time. * Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. * Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading. * This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. * Must be able to communicate with others to exchange information. 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 setting. #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.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Data Governance Lead , at Gilead you will ...lead the implementation of a comprehensive data governance strategy that ensures data accessibility, compliance to regulations and contracts, and ensure consistency of governance practices across clinical trial and real-world evidence (RWE) data. This role provides functional leadership and tactical excellence in aligning data governance with corporate goals, regulatory requirements, and long-term business needs. Key Responsibilities Strategy & Leadership Develop and execute a data governance strategy for clinical trial and RWE data. Maintain and improve governance processes and procedures. Ensure governance roles and models are appropriate across the data lifecycle. Compliance & Regulatory Alignment Ensure proper adherence and compliance to all applicable regulations Including: EMA Policy 0070: Anonymization and redaction of CSRs. Health Canada PRCI and EU CTR: Transparency and data sharing mandates. Data privacy laws (GDPR, HIPAA, CCPA): Including cross-border data transfers. Collaborate with CDS, Regulatory, and Legal teams to translate regulations into policies and SOPs. Data Access & Sharing Oversee internal and external data sharing governance: Maintain anonymization algorithms and methodologies. Manage data requests for licensed RWE and clinical trial data. Support DUAs, data sharing committees, and risk-based reviews. Ensure transparency and traceability in data sharing decisions. Gather and implement Industry best practices as published by Trancelerate, Phuse and others on data sharing and anonymization. Operational Oversight Partner with CDS and Gilead Data Office to embed governance in operations. Define governance roles for: Data retention, destruction, and archival. Anonymization standards and re-identification risk mitigation. Support due diligence for third-party data sources and vendors. Technology & Innovation Evaluate and support governance technologies (e.g., data catalogs, lineage tools). Promote FAIR principles and interoperability standards (e.g., CDISC, OMOP, HL7 FHIR). Develop and maintain request portals and wikis in support of content dissemination and continuous learner. Collaborate with IT and cross-functional teams to modernize governance tools and systems. Basic Qualifications Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR PhD/ PharmD and Two Years' Experience Preferred Qualifications: 6+ years in pharma, biotech, or medical research. 4+ years working with data. 2+ years in data governance, clinical data management, or RWE leadership. Proficiency in a programming language such as MATLAB, SAS, R, Python, or SQL. Intermediate skills in Smartsheet, Azure DevOps, or MS PowerApps. Understanding of clinical and RWE data structures, regulatory frameworks, and privacy laws. Familiarity with EMA Policy 0070, EU CTR, GDPR, HIPAA, and anonymization techniques. Experience with governance tools (e.g., Collibra, Informatica) and data platforms (e.g., CPRD, Aetion). Strong leadership, collaboration, and communication skills. Ability to operationalize legal and regulatory requirements. Strategic mindset with a focus on execution and ethical data stewardship. People Leader Accountabilities: •Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. •Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. •Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: $153,935.00 - $199,210.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

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. Position Summary The Dir, Strategy & Operational Excellence for the Dermatology Business Unit serves as the strategic and operational partner to the General Manager (GM), Dermatology. This leader drives business performance, organizational alignment, and executional excellence across all aspects of the dermatology portfolio. The Director ensures seamless integration of strategic priorities across commercial, medical, and functional teams, optimizing resources to accelerate growth and operational effectiveness. This role oversees strategic planning for the unit, partnering closely with senior leadership to ensure delivery against long-term objectives and product launch milestones. The Director represents the GM in key strategic forums and coordinates business updates for executive leadership, board communications, and cross-company initiatives. Success in this role requires strong influence, collaboration, and credibility at all levels of the organization, particularly within the leadership team. Key Responsibilities Strategic Leadership & Planning Lead development and execution of the Dermatology Business Unit's strategic and operational plans in alignment with corporate goals. Partner with the GM to translate strategy into actionable priorities and measurable outcomes. Identify market opportunities, business risks, and growth levers across current and future dermatology assets. Operational Excellence & Integration Drive continuous improvement in processes, organizational structure, and business rhythm to enhance efficiency and accountability. Oversee operational reviews, performance metrics, and cross-functional coordination to ensure timely and effective execution. Lead preparation and coordination of key business reviews, including Leadership Team, Executive Committee, Board updates, earnings calls, and major meetings. Cross-Functional Collaboration & Launch Readiness Serve as a strategic integrator across Sales, Marketing, Market Access, Medical Affairs, Patient Solutions, Analytics, Legal, Compliance, and Finance. Ensure alignment and executional excellence in all product launch and co-commercialization activities. Partner with global and clinical development teams to align commercial and development strategies for Ruxolitinib Cream and other pipeline assets. Business Insights & Decision Support Lead business performance tracking, analysis, and reporting to inform strategic decision-making. Develop business cases and scenario analyses for key investments, launches, and portfolio decisions. Support effective internal and external communications on business performance, strategy, and milestones. Qualifications Education & Experience Advanced degree (MBA, PhD, or equivalent) preferred. 5+ years of experience in the life sciences or biopharmaceutical industry with demonstrated success in strategic planning, operations, or general management roles. Leadership Competencies Proven track record in leading cross-functional teams and driving complex strategic initiatives. Exceptional organizational, analytical, and project management skills. Strong executive presence and communication skills, with the ability to influence, align, and drive decisions at all levels of the organization, including within the leadership team. Ability to operate effectively in a dynamic, fast-paced environment requiring both strategic and hands-on execution. 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: 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 if you have any questions or concerns or would like to exercise your rights.