NanoString Technologies jobs - 840 jobs

A leading biopharmaceutical company is seeking an Associate Director to serve as Regional Regulatory Lead, overseeing complex regulatory submissions and managing cross-functional teams. The ideal candidate should have significant regulatory experience, a strong track record in strategy development, and excellent negotiation skills. This role offers a chance to influence drug development processes in a dynamic environment. #J-18808-Ljbffr

Privacy Ops & Assurance Associate Director page is loaded## Privacy Ops & Assurance Associate Directorlocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-27365**Job Description****General Summary:**The individual in this position will provide strategic and solutions-oriented advice to a broad spectrum of internal clients on worldwide regulatory issues related to the processing of personal data, including but not limited to the US State Privacy Laws, Section 5 of the FTC Act, CAN-SPAM, EU General Data Protection Regulation (GDPR), and Canadian privacy laws. The role will also support the maturation of privacy-related policies, notices, and SOPs, supporting the strategic direction for the global privacy program and related processes and training.**Key Duties and Responsibilities:*** Performing regular privacy assessments of new and existing business processes (including through data inventories and data protection impact assessments), providing practical and timely advice to internal clients to design business processes in compliance with applicable data protection requirements, including those relating to data transfers, while addressing risks and protecting the company's integrity and reputation.* Acting as subject matter expert and internal escalation point for data protection issues in contracting, including data processing agreements, research collaborations, and transactional agreements; continue to develop template materials for contracting and advise/train members of the legal department on handling privacy-related language in contracts.* Working closely with our contracting teams to improve and streamline contracting processes and procedures related to data protection and security.* Drafting privacy notices and consents for business processes across the organization, and maintaining the organization's privacy and cookie notices on company websites* Developing and reviewing content for privacy training materials and other communications to increase employee understanding of company privacy policies, data handling practices and procedures and legal obligations, as well as to ensure awareness of “best practices” on privacy and data security issues.* Evaluating and responding to data subject requests (e.g., request for information, clarifications, rectification, or deletion of personal data) and reports of potential data incidents. Supporting the monitoring* Supporting the monitoring/auditing plan for compliance with internal data protection policies and processes and working with Internal Audit function, Office of Business Integrity and Ethics or external auditors in carrying out audit plans.* Keeping abreast of privacy developments affecting the company (e.g., evolving guidance out of the European Union, California Privacy Act, discussions of US privacy laws, CAN-SPAM, e-privacy and developments in Artificial Intelligence) and anticipating potential changes needed to global privacy program to meet new regulatory requirements.* Participating in various Legal & Compliance Department projects and initiatives (e.g., Culture, Diversity, & Inclusion Committee, Pro Bono & Community Engagement Committee, Talent & Development Committee, offsite planning, strategic planning).**Knowledge and Skills:*** Consummate team player with excellent judgment and interpersonal skills.* Demonstrable program management skills, including strong organizational and multi-tasking abilities.* Demonstrated teamwork and collaboration skills, in particular in leading or contributing to global and multi-functional teams.* Highly motivated to contribute and grow within a complex area of emerging importance.* Demonstrable experience taking ownership of issues and providing timely, actionable advice.* Exceptional written, oral and presentation skills.**Education and Experience:*** JD from an ABA accredited law school and member of a state bar or Master's degree highly preferred* Minimum of 5 years' experience providing privacy advice, preferably to pharmaceutical, biotechnology, or medical device companies, whether in-house or at a law firm OR experience in management of a corporate privacy program.* Specific expertise required in statutes, regulations and guidance concerning data protection throughout the US and Europe, which could include GDPR and the ePrivacy Directive, CCPA, CPRA, as well as other US privacy requirements (Section 5 of the FTC Act, CAN SPAM, state breach notification laws). Familiarity with data protection statutes and regulations in other areas of the world a bonus.* CIPM, CIPP/US or CIPP/EU certification(s) preferred but not required#LI-DB1#HYBRID**Pay Range:**$168,800 - $253,200**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com #J-18808-Ljbffr

A leading biotechnology company in Boston is seeking an experienced Senior Director, Finance Technology to drive innovation across Financial Systems, focusing on Tax, Treasury, and Accounting. The ideal candidate will have over 12 years of experience in financial systems leadership, strong stakeholder engagement skills, and a passion for technology. This role offers competitive compensation and hybrid work options. #J-18808-Ljbffr

A leading biopharmaceutical company is seeking a Senior Director for Medical Affairs to lead initiatives focused on liver diseases. The ideal candidate should have substantial clinical experience in hepatology and a commitment to scientific excellence. This remote position requires strategic collaboration and contributions to research efforts to improve liver care outcomes. Strong leadership and communication skills are essential for engaging diverse healthcare professionals in clinical discussions. #J-18808-Ljbffr

A global biotechnology company is seeking an Associate Director, Consumer Media Strategy & Execution to lead media strategies and enhance digital presence in the US Kidney Business Unit. The role requires a strong background in media planning, buying, and analytics. Candidates should have excellent leadership skills and be capable of collaborating with cross-functional teams. The position offers flexibility to work either hybrid or on-site, with a competitive benefits package including bonuses and educational assistance. #J-18808-Ljbffr

A leading biopharmaceutical company is seeking an Associate Director of External Manufacturing to oversee Contract Manufacturing Organizations (CMOs) for cell and gene therapy solutions. This role will require a focus on operational oversight, regulatory compliance, and effective project management. The ideal candidate will have over 10 years of experience in the biotech sector, particularly in cGMP environments, and will demonstrate strong leadership and communication skills. This position offers flexible work options, including remote and hybrid arrangements. #J-18808-Ljbffr

A leading pharmaceutical company is seeking a Senior Principal Analyst to act as a strategic liaison between Marketing stakeholders and technical teams. This role focuses on optimizing the Marketing Technology ecosystem while ensuring compliance with industry regulations. The ideal candidate will have 8+ years in Marketing Technology, with deep expertise in tools like Salesforce Marketing Cloud and Tealium. Strong project management and communication skills are essential, along with the ability to translate requirements into clear deliverables. This role offers a hybrid work environment with competitive benefits. #J-18808-Ljbffr

The External Innovation (EI) Executive Director leads end‑to‑end identification, evaluation, and advancement of external opportunities that materially strengthen Vertex's R&D pipeline across modalities (e.g., small molecules, biologics, CGT, RNA, delivery platforms) and enabling technologies (e.g., discovery, translational, and manufacturing tools). The role orchestrates integrated, cross‑functional analyses and converts opportunity signals into clear, decision‑ready recommendations for EI governance (EI Science, BDSC) and the Executive Committee. Culture & talent: Foster an environment consistent with EI competencies (business‑minded leader, insight generator, influential communicator, trusted partner, change enabler, technical expert).**Required Education:** PhD (or equivalent advanced degree) and 15+ years of biotech/pharma experience spanning discovery and/or early development; or an equivalent combination of education and experience.**Required Experience**Proven ability to build and manage high‑performing analyst teams and to operate an integrated analysis model. **Required Knowledge & Skills**Business acumen: Valuation literacy; option‑value framing; scenario and risk modeling; ability to articulate value drivers and deal concepts (from partnerships to company creation/M&A). Influential communication: Executive‑quality narratives and visuals; clear storyline from problem framing to recommendation; ability to lead with facts and secure alignment. The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility. #J-18808-Ljbffr

A leading biotechnology company is seeking an Associate Director of Marketing Sciences to enhance predictive analytics within its commercial operations. This pivotal role involves driving innovative data-science initiatives, collaborating across teams, and fostering a culture of measurement. With responsibility for leading end-to-end projects and developing insightful products, the ideal candidate will possess strong expertise in machine learning and data analysis, along with effective leadership and communication skills. This position is hybrid based in California or New Jersey. #J-18808-Ljbffr

A global biotechnology company in Boston is seeking an Associate Director, Vendor Quality Management. This role involves monitoring vendor quality and compliance in regulated environments and works closely with QA and business partners. The ideal candidate has a Bachelor's degree and at least 8 years of experience in regulatory requirements and risk management. The position offers flexibility to work hybrid or on-site and comes with a competitive salary range. #J-18808-Ljbffr

The Senior Meetings & Events Planner will be responsible for delivering strategic meeting planning for a variety of meetings independently and with the support of preferred logistics vendors. This role will be skilled in ensuring seamless execution of highly complex events while fostering strong relationships with global teams and suppliers. The ideal candidate will demonstrate problem-solving and interpersonal skills with a global point of view, and partner with cross-functional planning teams to ensure meeting logistics and planned activities are aligned and support the overall meeting goals and objectives. The ideal candidate must possess strong HCP/Compliance knowledge and experience and the ability to act as a solid meetings management resource both internally and externally. Key Duties & Responsibilities * Provides strategic guidance support and management to preferred logistics agencies on an event-by-event basis. * Strong project management skills managing multiple projects, vendors, and processes. * Consult and navigate cross-functional planning teams, vendors, and Business Owners through complex logistical planning by setting roles & responsibilities, adherence to HCP compliance and transfer of value, meeting best practices and strategy, and expectation of deliverables. * Demonstrated ability to build and manage complex budgets and guide vendors to manage multiple budgets with different timelines and deliverables. * Identify and resolve day-to-day matters related to project requirements, cross-functional processes, and vendor management operations. * Build and maintain strong partnerships with Business Owners and consult on meeting goals & objectives to provide strategic support solutions. * Ability to strategically engage and advise Business Owners across diverse meeting formats and therapeutic areas * Must possess ability to manage, communicate and interact with various of levels of internal business owners in professional and knowledgeable manner at all times * Strong adherence to internal & HCP compliance, transparency rules and reporting, knowledge and understanding of GDPR requirements. * Ability to travel domestically and globally at least 30% of the time. Required Education Level * Bachelor's Degree Required Experience * 5+ years of global meeting & event planning experience * Previous Pharmaceutical Experience a plus * Supplier/Vendor management experience a plus Required Knowledge/Skills * Proficient and professional meeting planning experience in a corporate setting. * Strong organization and time management skills, ability to simultaneously keep multiple projects prioritized and moving with multiple stakeholders. * Experienced contract negotiations skills with in-depth understanding of hotel and venue legal and business terms. Ability to guide negotiations of venue and vendors contracts, securing the best possible terms to provide Vertex with the most flexibility, financial security and cost saving opportunities. * Strong verbal and written communication skills, comfortable in group and individual presentations across all levels of the organization. * Strong knowledge of HCP Compliance regulations and ability to apply critical thinking to identify and escalate compliance risks to the Office of Business Integrity & Ethics while adhering to and implementing guidelines and monitoring team adherence. * Committed to delivering the highest level of customer service. * Flexibility and ability to successfully navigate ambiguity and succeed in a rapidly changing, fast-paced, deadline-driven environment with multiple priorities. * A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society. Other Requirements * Proficient in Microsoft Office suite. * Prior working knowledge of Cvent Event Management software program preferred. * CMP and or CMM Certification (a plus but not required) #LI-hybrid #LI-TC1 Pay Range: $91,200 - $136,800 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

develops and provides strategic direction and leads daily operations of the US care management team supporting the US, Heme Business Unit. This individual will represent the US on the global cross-functional manufacturing team, developing slot allocation policies, managing exceptions processes, and managing system/manufacturing capacity. This individual will also play a key role in ensuring exceptional support is provided to our customers by our care manger team. This critical role will be highly cross functional within Vertex with the goal of providing industry-leading patient support through patient facing interactions and logistical coordination.Exceptional leadership and collaboration skills, as well as a strategic mindset are essential to the role. Strong partnerships will be required with internal functions such as finance, supply chain, manufacturing, IT, and other commercial colleagues. This individual will report to the Head of US Heme Patient Support. **Key Responsibilities:** Clear and consistent communication of roles, responsibilities, and performance expectations Daily monitoring to ensure consistent execution of all program requirements Consistent refinement and development of the CM role to ensure provision of impactful support in the logistical coordination of support activities and customer relationship development Support US OMstrategy and process optimization to ensure the processes support global OM goals and the best possible customer experience including but not limited to:System requirements (VCP and BEACON) Oversight and optimization of CM OM roles and responsibilities EHR and portal system requirements (VCP and BEACON)**Qualifications:** Strong customer service focus and the ability to act with urgency to respond to customer needs CGT experience preferred 5+ years' experience as impactful people-leader preferably in the biotech/pharma environment Excellent communication, interpersonal, and leadership skills Ability to act with urgency to ensure time-critical activities are completed while ensuring all stakeholders are on-board and have clarity around the goals and objectives Business savviness and ability to streamline processes and find opportunities for improvement Must be able to effectively work in a fast-paced environment, with strong time-management skills10+ year's work experience in the biotech/pharma environment Excellent communication, interpersonal, and leadership skills Ability to act with urgency to ensure time-critical activities are completed while ensuring all stakeholders are on-board and have clarity around the goals and objectives Ability to take complex situations and break them down into simple parts to enable stakeholders to make decisions / take actions Business savviness and ability to streamline processes and find opportunities for improvement Must be able to effectively work in a fast-paced environment, with strong time-management skills The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility. #J-18808-Ljbffr

**Job Description**Vertex is growing at a rapid pace with challenging and exciting opportunities for motivated professionals who are keen to contribute to the Vertex mission to invest in scientific innovation to create transformative medicines for people with serious diseases. Our robust and complex R&D pipeline requires a focus on efficiency and prioritization as we scale. The Vertex finance function is integral to achieving our company's strategic goals, providing critical insights and analysis in support of decision-making across the organization. We are investing in our ability to provide data-driven insights by organizing and automating financial data and processes to enable our growing global scale. We are also leveraging best practices to strengthen our business partnering and decision support capabilities. By joining our function, you will become part of a fast-moving, forward-thinking team to support the ongoing growth of a leader in the biotechnology industry.**General Summary:**The Senior Director, Global Development FP&A is a seasoned finance leader who partners directly with our Global Clinical Development (early- and late-stage programs) organizations and cross-functional program teams to run global financial planning, forecasting, and strategic analysis. Reporting to the VP of R&D Finance, this highly visible role serves as a strategic advisor to the Chief Medical Officer's organization and senior leadership, influencing portfolio prioritization and investment decisions through financial insights. The ideal candidate brings deep expertise in clinical trial finance, executive presence, and a proven ability to drive business outcomes in a dynamic, science-driven environment.This role is for you if you possess strong decision support analytical skills, project management expertise, team management skills, and demonstrated ability to collaborate with cross-functional teams to drive innovation and deliver successful product development outcomes.**Key Duties and Responsibilities:**A key leader in financial planning and analysis within our function, your responsibilities entail:Advanced Scenario Planning and Risk Analysis:* Build, maintain, and own clinical program-level budgets (Phase 1 to Phase 3), clinical trial cost models, and forecasts; produce cost-to-complete and cost per patient analysis used in strategic decisions.* Lead advanced scenario modeling for clinical programs, including sensitivity analyses on timelines, enrollment rates, and regulatory milestones to inform go/no-go decisions.* Translate clinical development plans into financial implications and ROI-based recommendations.Strategic Influence and Business Partnership:* Participate in cross-functional program teams and governance committees, providing real-time financial guidance.* Deliver program dashboards, KPIs and trend analyses for executive and portfolio reviews.* Prepare and present executive-level updates.Team Leadership:* Lead and develop a team of 6-8 clinical finance professionals: set team priorities, establish processes, and build scalable operating mechanisms for financial support* Drive automation and digital transformation of clinical finance processes, leveraging tools like Hyperion, Oracle, and emerging analytics platforms to improve accuracy and scalability* Mentor staff on forecast accuracy, stakeholder management and financial modeling best practices* Drive a collaborative, service-oriented culture between finance and Global Clinical Development organizations Governance and Compliance Leadership:* Oversee month-end and quarter-end close activities related to clinical expense (accruals, reconciliations, GL review).* Ensure accurate, timely accruals for CROs, FSPs, sites, labs and other clinical vendors. Maintain audit-ready documentation for clinical program spend* Improve transparency and accountability around clinical opex and resource allocation through clear processes, benchmarks and metrics**Basic Requirements:*** Bachelor's degree in finance, Accounting, or related field; MBA or CPA/CFA strongly preferred.* 12+ years of progressive FP&A experience, with at least 5 years in the pharmaceutical or biotech industry.* Experience supporting R&D or Clinical Development functions at a global scale.* Strong understanding of R&D processes, portfolio management, and project evaluation methodologies.* Proven ability to manage complex budgets, forecasts, and analyses in a dynamic, fast-paced environment.* Excellent communication and presentation skills, with the ability to influence stakeholders at all levels and a proven ability to present complex financial insights to senior stakeholders.**Important Knowledge and Skills:*** Deep understanding of pharmaceutical industry dynamics and executive-level business partnering.* Hands-on exposure to clinical operations and/or CRO/FSP budgeting.* Strong analytical capabilities in portfolio analysis.* Proficiency in Microsoft Office and financial systems, including Hyperion and Oracle.* Proven ability to lead change in complex, cross-cultural matrix environments.* Exceptional communication and influencing skills across senior leadership and cross-functional teams.* Ability to apply broad market knowledge to drive financial performance and strategic outcomes.* Strategic thinker with attention to detail.#LI-DB1#HYBRID**Pay Range:**$212,000 - $318,000**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status:**In this Hybrid-Eligible role, you can choose to be designated as: 1. **Hybrid**: work remotely up to two days per week; **or select** 2. **On-Site**: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.#LI-Hybrid**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com #J-18808-Ljbffr

The Executive Medical Director, Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads, DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex's world markets. Overseeing the GPS DASH/DST teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST teams, including pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with leaders from cross-functional teams on the successful achievement of key strategic activities, initiatives and deliverables. Key Duties and Responsibilities: Provides leadership and oversight of DASH/Disease-area Safety Team(s) (DST) conduct, for all products across the Vertex Portfolio, including pre-FIH activities, key benefit-risk assessment, and providing strategy for DSTs to meet goals and objectives. Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals, in accordance with Vertex signal detection practices. Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, both pre-approval and post-approval, as needed. Collaborates with NDA teams assessment, strategy and execution of key Regulatory Authority documents in support of submissions, specifically leading safety content of key Modules (SCS, CLO, Labelling) and development of any Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plan (RMP) or equivalent documents. Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies, as needed. Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (DSURs, PSURs/PBRERs), IND packages, as well as NDA and INDs. Provides review and safety-specific input for labeling documents, including IB, CCDS, USPI, SmPC and other local labels, as applicable. Collaborates with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries. Provides and oversees medical review of aggregate and/or individual post-marketing and clinical trial adverse event reports, in accordance with GPS review practices. Oversees medical evaluation of other relevant non-AE/SAE related safety information, such as from Toxicology, Non-Clinical studies and Product Quality sources. Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Statistical Analysis Plan, IB, ICF and IDMC Charter. Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports. Reviews and provides oversight of safety sections of clinical study reports. Provides a contributory role in Partner /Affiliate agreements and interactions, as needed. Serves as Subject Matter Expert in departmental development activities including SOP and Work Instructions development. Leads Medical staff and liaise with Operations leads regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective. Leads and guides direct reports, regarding the scope of DASH/DST Chair Physician responsibilities, and the provision of sound medical input for all pre-marketing and post-marketing activities. Facilitates the growth and development of staff and direct reports. Knowledge and Skills: Extensive knowledge of GCP, ICH and Global regulations. In-depth and comprehensive knowledge of General Medicine. Strong leadership skills with the ability to communicate effectively in a matrix environment. Experience in the critical evaluation and interpretation of data, with ability to synthesize into clear, coherent messaging. Extensive knowledge of Benefit-Risk strategies and decision-making. Ability to multi-task, adeptly handling multiple demands. Education and Experience: MD, DO or equivalent ex-US medical degree 12+ years of work experience with experience in Pharmacovigilance and 7 years of supervisory/management experience, or the equivalent combination of education and experience #LI-AR1 Pay Range: $312,000 - $468,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

A biopharmaceutical company is seeking a Senior Manager for Global Regulatory Affairs in Oncology. This role involves acting as the Regional Regulatory Lead, defining regulatory strategies for multiple products, and representing the company in negotiations with regulatory authorities. The ideal candidate will possess significant regulatory experience in the biopharma sector and proven leadership skills. This position is remote and full-time, primarily based in the United Kingdom. #J-18808-Ljbffr

A leading biotechnology company is seeking a Director of Market Access Strategy focused on Heme. This role involves developing market access strategies, collaborating across teams for effective payer solutions, and ensuring reimbursement for CASGEVY. Candidates should have over 10 years of experience in Market Access and a strong understanding of the US healthcare landscape, with excellent project management skills. The position is hybrid, allowing for flexible remote work. #J-18808-Ljbffr

External Manufacturing Operations The primary focus of the Associate Director, External Manufacturing role is to oversee Vertex's critical cell and gene therapy Contract Manufacturing Organizations (CMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be located either at the cell and gene therapy CMO's site and/or be able to travel up to 50% of their time to those sites as a “Person-in-Plant” to oversee activities on the ground, and/or as a SME to provide technical support to resolve emerging issues. The successful candidate will be a key member of the Vertex/CMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities.**Key Responsibilities:** Provide operational oversight of, and troubleshooting support to, CMOs to ensure all deliverables meet or exceed Vertex and regulatory requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management); be Vertex's “eyes and ears” at the CMO for right-first-time execution of commercial operations.Work closely with CMO and internal Quality and Technical teams to prioritize, monitor, track, review and deliver required compliance documentation (including but not limited to change controls, investigations and deviations, batch data, CAPA effectiveness, internal/external audit observation deadlines, regulatory commitments) to meet Vertex program requirements.**Minimum Requirements:**Bachelor's degree required, ideally in cell biology, or closely related in Life Sciences disciplines (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 10+ years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing/operations leadership role working with or in cGMP facilities within the biotechnology industry.Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations.Solid project management skills and experience managing complex projects. Strong verbal and written communication skills: ability to express oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.Strong leadership and an innate ability to collaborate and build relationships is critical.Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change Ability to travel, national and international, up to 50%Excellent computer skills including Microsoft (Word, Excel, Project, Outlook, Teams), equipment interfaces and electronic quality systems**Desired Additional Skills**: Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience.Solid experience in equipment and facility qualification and validation for ATMP CMO'sOffice and cleanroom - must be able to comply with cleanroom gowning requirements at CMOMust be comfortable moving about inside the cleanroom to oversee process tasks The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.In this Remote-Eligible role, you can choose to be designated as: 1. **Remote**: work remotely five days per week and come into the office on occasion - you're always welcome on-site; **or select** 2. **Hybrid**: work remotely up to two days per week; **or select** 3. **On-Site**: work five days per week on-site with ad hoc flexibility. #J-18808-Ljbffr

The Patient Support Business Systems Manager supports the Kidney Patient Support team by managing the launch and continuous improvement of a new customer relationship management (CRM) system. This is an individual contributor role and a member of the US, Patient Support Center of Excellence (CoE). The Patient Support Business Systems Manager partners deeply with Patient Support, Access & Reimbursement, Training, Quality & Compliance, Field teams, Data & Analytics, and Technology partners to translate business needs into scalable digital workflows, integrations, analytics, and enhancements that improve speed-to-therapy, patient experience, and operational efficiency. This role manages the CRM system and digital engagement tools that patient support specialists use in their day-to-day workflows to engage with patients and HCPs, specifically where processes overlap, and systems are integrated. Key Duties and Responsibilities: Collaborate with business stakeholders to gather and groom functional requirements, then communicate with technical teams to translate items into technical system requirements. Strong background and working knowledge of AI-enabled patient service capabilities to improve access, speed to therapy, and patient/HCP engagement while meeting compliance and data governance standards Build and maintain end to end process flows across patient access and engagement journeys; facilitate functional and technical workshops to document current/future state, surface inefficiencies, and convert opportunities into prioritized backlog items and measurable workflow optimizations. Align and support creation of the annual business project plan and roadmap for Patient Services CRM with clear milestones and dependencies based on the overall vision. Ensure full alignment with Data, Technology and Engineering (DTE) function. Facilitates capability prioritization discussions with PSP team and can speak to their perspective on business priorities. Using strong project management, leadership, and communication skills hold self and PSP team accountable to stay on track with deliverable deadlines for requirements and annual planning. Works closely with DTE Project Manager to oversee end to end sprint management activities and ceremonies. Managing the product backlog, proactively raising issues and constantly conducting prioritization exercises based on changing business requirements within Jira. Participate in the RFP process for tools, technologies, and support with DTE. Provides Implementation support including validation of business requirements and User Acceptance Testing (UAT). Partner with Commercial Training and Change Management teams to ensure necessary supporting materials are provided and training content is consistent with system functionality. Knowledge and Skills: Experience in supporting commercial systems for patient support programs/hub services a plus Demonstrated strong project management, troubleshooting, and problem-solving skills Proven track record of success with strong results and excellent customer relationship skills Expected to be knowledgeable of the CRM system and digital engagement tools with patients/HCPs, understanding where processes and systems overlap and integrate to help drive process efficiencies for patient support specialists Excellent interpersonal, communication, organizational and facilitation skills Proactive, Self-motivated, Independent worker Passion for understanding emerging technologies with pragmatic insight into where those technologies can be integrated into business solutions Able to perform in a fast-paced environment, manage multiple priorities simultaneously, and communicate complex information clearly Education and Experience: Bachelor's degree in computer science, software engineering or other related technology degree. Salesforce certifications 5+ years' relevant experience in life sciences organization or healthcare industry, including experience working with Salesforce platform, Salesforce Life Sciences Cloud / Health Cloud or similar CRM Pay Range: $124,000 - $186,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

The Senior Meetings & Events Planner will be responsible for delivering strategic meeting planning for a variety of meetings independently and with the support of preferred logistics vendors. This role will be skilled in ensuring seamless execution of highly complex events while fostering strong relationships with global teams and suppliers. The ideal candidate will demonstrate problem-solving and interpersonal skills with a global point of view, and partner with cross-functional planning teams to ensure meeting logistics and planned activities are aligned and support the overall meeting goals and objectives. The ideal candidate must possess strong HCP/Compliance knowledge and experience and the ability to act as a solid meetings management resource both internally and externally. Key Duties & Responsibilities Provides strategic guidance support and management to preferred logistics agencies on an event-by-event basis. Strong project management skills managing multiple projects, vendors, and processes. Consult and navigate cross-functional planning teams, vendors, and Business Owners through complex logistical planning by setting roles & responsibilities, adherence to HCP compliance and transfer of value, meeting best practices and strategy, and expectation of deliverables. Demonstrated ability to build and manage complex budgets and guide vendors to manage multiple budgets with different timelines and deliverables. Identify and resolve day-to-day matters related to project requirements, cross-functional processes, and vendor management operations. Build and maintain strong partnerships with Business Owners and consult on meeting goals & objectives to provide strategic support solutions. Ability to strategically engage and advise Business Owners across diverse meeting formats and therapeutic areas Must possess ability to manage, communicate and interact with various of levels of internal business owners in professional and knowledgeable manner at all times Strong adherence to internal & HCP compliance, transparency rules and reporting, knowledge and understanding of GDPR requirements. Ability to travel domestically and globally at least 30% of the time. Required Education Level • Bachelor's Degree Required Experience 5+ years of global meeting & event planning experience Previous Pharmaceutical Experience a plus Supplier/Vendor management experience a plus Required Knowledge/Skills Proficient and professional meeting planning experience in a corporate setting. Strong organization and time management skills, ability to simultaneously keep multiple projects prioritized and moving with multiple stakeholders. Experienced contract negotiations skills with in-depth understanding of hotel and venue legal and business terms. Ability to guide negotiations of venue and vendors contracts, securing the best possible terms to provide Vertex with the most flexibility, financial security and cost saving opportunities. Strong verbal and written communication skills, comfortable in group and individual presentations across all levels of the organization. Strong knowledge of HCP Compliance regulations and ability to apply critical thinking to identify and escalate compliance risks to the Office of Business Integrity & Ethics while adhering to and implementing guidelines and monitoring team adherence. Committed to delivering the highest level of customer service. Flexibility and ability to successfully navigate ambiguity and succeed in a rapidly changing, fast-paced, deadline-driven environment with multiple priorities. A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society. Other Requirements Proficient in Microsoft Office suite. Prior working knowledge of Cvent Event Management software program preferred. CMP and or CMM Certification (a plus but not required) #LI-hybrid #LI-TC1 Pay Range: $91,200 - $136,800 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com