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  • Associate Director, Site and Monitoring Health

    Alnylam Pharmaceuticals, Inc. 4.8company rating

    Remote Alnylam Pharmaceuticals, Inc. job

    The Associate Director, Site and Monitoring Health will provide strong leadership, GCP expertise and clinical operations experience to drive the monitoring strategy for trials in their assigned program(s). They are responsible for co-directing (in a matrix environment) the extended team to safeguard the quality of clinical trial execution at investigator sites and ensure Alnylam's oversight of CRO monitoring effectiveness. The Associate Director, Site and Monitoring Health will line manage and matrix manage Site and Monitoring Health staff and direct the work of FSP Site and Monitoring Health Leads. This position reports to the Director, Site and Monitoring Health or above. Summary of Key Responsibilities * Develop, implement, and oversee Alnylam's Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8, ensuring that monitoring plans for trials assigned reflect the strategy and the trial budget is aligned. * Lead, direct, and support Site and Monitoring Health Leads in assessing CRO monitoring effectiveness across the portfolio. * Direct day-to-day work activities for FSP Vendor Site and Monitoring Health Leads * Liaise with CRO partners and internal partners (including Clinical Risk & Analytics and Study Management) to ensure overall understanding of monitoring strategy and alignment among trial plans. * Consistently manage oversight activities at the program level as aligned and ensure Study Specific Oversight Plans are appropriately implemented and followed for all studies within scope. * Drive a culture that balances purposeful urgency with passion for excellence, employ risk-based thinking to focus on what is critical to quality, and emphasize an "inspection ready at all times" mentality. * Develop and maintain effective working relationships with stakeholder functions to achieve Clinical Operations' goals. * Assist in planning and trial optimization to evolve the Clinical Operations organization as we scale for the future. * Participate in various workstreams and projects as a leader in Clinical Operations to improve and refine processes. * Ensure Site and Monitoring Health Leads complete administrative tasks on time and facilitate their continuous development. * Determine resourcing needs within Site and Monitoring Health and workload allocation based on the portfolio. * Support inspection preparation and management. * Maintain awareness of changes in industry and regulatory standards for GCP requirements and share updates with Site and Monitoring Health Team * Travel (including occasional global travel) averages Requirements * Bachelor's Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD,) is preferred * Previous experience in Sponsor Oversight, Site and Monitoring Health, RBQM+, and Line Management preferred * Proven experience in effectively leading teams and regional remote-based staff * Solid direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/CRA management experience preferred * Experience in all study phases of clinical research (Phase I-IV) and experience in rare medical conditions preferred * Previous regulatory inspection experience preferred * Comprehensive and current regulatory knowledge, including GCPs Skills * Ability to concisely present significant issues and criticality to senior leaders * Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions * Ability to build and maintain relationships with key investigators and sites (e.g. key networks, key trial sites and investigators, key opinion leaders and their site staff * Innovator, willing to initiate changes, introduce new ideas, and creatively problem-solve * Experience with Microsoft based applications and ability to learn internal computer systems * Effective leader and collaborator with the ability to work consistently, flexibly, and adjust to changing priorities in a fast-paced environment * Effectively manage and develop others to be successful at Alnylam and meet the needs of Clinical Trial Oversight and the broader organization * Analyze complex situations and effectively communicate issues along with potential recommendations to various functional groups * Demonstrate good judgment and decision-making experience * Ability to delegate tasks and oversee delegated activities U.S. Pay Range $165,300.00 - $223,700.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity). Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together. Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: ******************************* About Alnylam We are the leader in RNAi therapeutics - a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.
    $165.3k-223.7k yearly 18d ago
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  • Meetings & Events Senior Planner

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Remote or Boston, MA job

    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
    $91.2k-136.8k yearly Auto-Apply 60d+ ago
  • Biostatistics Director (Hybrid)

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    The Director, Biostatistics will independently perform highly scientific statistical functions in support of the company's Global Medicines Development and Affairs (GMDA) area on new and complex issues. The incumbent will complete work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results if needed. In addition, the Director provides independent strategic and technical contributions. The incumbent possess an excellent knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset. As a people manager within the organization, has financial accountabilities and human resource responsibilities for assigned staff. Key Duties and Responsibilities: Directs one or more projects including multiple clinical trials, observational studies, or real world data (RWD) investigations. Also includes presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards. Manage a team of direct reports including their performance and development. Mentors project team members and promotes effective team operation and cross-functional collaboration. Possesses an expert understanding of modern drug discovery and development processes. Represents Biostatistics as a member of cross functional teams, providing strategic input and expert technical guidance to elicit meaningful and/or productive outcomes. Sets the technical and scientific directions of the project(s). Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) to facilitate the review, summary, and dissemination of key study data/results. Leads collaboration with statistical programming and other functions to ensure high quality and technically sound delivery of TFLs. Leads or contributes to external interactions with regulators, payers, review boards, etc. Authors or co-authors methodological or study-related publications and posters. Leads implementation of innovative designs and analysis methods at the study or project level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others. Contributes to departmental working group efforts on key various technical and operational issues. Independently undertakes new and highly complex issues requiring advanced analytical thought. Completes work in a resourceful, self-sufficient manner; conceptualizes alternative, and at times untested, approaches to achieve desired results. Maintains and expands in-depth knowledge of related disciplines with a drug developer mindset. Knowledge and Skills: Prior staff management experience Project management and project team oversight Expertise with SAS and R statistical software Demonstrated expertise in advanced/complex statistical methods used in drug development Deep skill in critical thinking and logical problem-solving Excellent written and verbal communication skills with the ability to influence opinions of peers and managers Excels in a team environment Collaborates well with non-statisticians and can effectively explain complex concepts to non-technical audiences NDA/MAA experience and direct dealings with USA/European regulators. Education and Experience: Ph. D. in Statistics or Biostatistics. Typically requires 10 years of experience with a Ph.D. #LI-AR1 #LI-Hybrid Pay Range: $164,800 - $247,200 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. 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
    $164.8k-247.2k yearly Auto-Apply 60d+ ago
  • Executive Medical Director, Patient Safety (Hybrid)

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    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
    $125k-173k yearly est. Auto-Apply 60d+ ago
  • Health Economics & Outcomes Research Associate Director (HYBRID)

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    Vertex is seeking a talented and motivated individual to join its Global Health Economics & Outcomes Research (HEOR) group based in Boston's Seaport District. The Health Economics & Outcomes Research Associate Director will participate in the shaping and execution of HEOR strategies that optimize the value proposition for Vertex's Cystic Fibrosis and early pipeline assets through each stage of development, including launch and post-launch phases. This position reports to the Senior Director HEOR, CF and Early Pipeline. Key Duties and Responsibilities: Leads execution of complex HEOR evidence generation studies, including: prospective and retrospective observational studies, systematic literature reviews, cost-effective analyses and budget impact models, Indirect Treatment Comparisons, COA strategy, PRO measure development and validation, as needed, to support the asset value Effectively leads external research partners to ensure robust scientific methods are applied to study design and execution and in compliance with all local regulations; is accountable for study design, data analysis and the quality of the evidence produced. Excellent project management is a pre-requisite to ensure studies delivered on time and within budget. Collaborates with the medical communications teams on publication strategy and ensure that dissemination of HEOR evidence is timely and has maximum impact Partners and works closely with Global Pricing and Market Access to support development of product value proposition/value messaging and co-lead development of robust Global launch deliverables (e.g., global value dossier) Knowledge and Skills: Strong track record of publication in peer-reviewed journals Strong background in clinical outcome assessment (COA) measurement strategy; experience in PRO development/validation and qualitative research methodology Technical expertise in HEOR; able to formulate and lead creative research projects and ensure conduct is technically and scientifically rigorous and reflects best HEOR practices Strong verbal and written communications skills, including presentation skills to communicate difficult concepts and persuade others; comfortable communicating complex concepts and adapting presentation style to a variety of audiences Ability to apply knowledge of US healthcare system, global health technology appraisal requirements, and clinical development, to identify evidence gaps and formulate evidence generation strategies Understanding of the legal and regulatory environment of the pharmaceutical industry, with spotless history of compliance and ethical workplace conduct Education and Experience: Advanced degree (PhD, MD, Master's degree, MPH, or PharmD) in a relevant discipline. Typically requires 8 years of experience, with substantial background in HEOR, or the equivalent combination of education and experience Pay Range: $172,000 - $258,000 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
    $74k-97k yearly est. Auto-Apply 60d+ ago
  • Portfolio & Program Management Senior Director

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    The Portfolio & Program Management Senior Director is a global role within the Portfolio & Program Management (PPM) organization. This role is a key leadership position providing strategic and operational program management leadership to the Narcolepsy Type 1 (NT1) Disease Strategy Team (DST). The incumbent is responsible for championing cross-functional program management excellence to programs across the drug development lifecycle (Research, Pre-clinical and Clinical Development, Registration and Commercialization). The incumbent is expected to apply deep subject matter expertise in program management to identify opportunities, shape objectives and drive execution of global strategies for cross-functional drug development and commercialization teams. Key Duties and Responsibilities: Provide strategic and operational program management leadership to the Narcolepsy Type 1 Disease Area Executive (DAE), Disease Strategy Team (DST) and cross-functional teams, directing activities at all stages of the program lifecycle (initiation through closeout) Drive communication cross-functionally and with senior leaders on integrated program planning topics including timelines, status, risks and interdependencies across a complex portfolio of pipeline programs. Proactively identify roadblocks and/or constraints impacting strategic imperatives or program execution and lead the team through scenario planning activities Partner with governance forums, senior leaders and/or team lead(s) to align strategy, goals and milestones with corporate objectives Propose innovative approaches, define process improvements and advise leaders on opportunities to optimize program results Determine approach and stakeholders for cross-functional decision-making and issue resolution Oversee completion of disease area deliverables and contribute to content development, when appropriate Establish project team operating norms and measure performance As a potential people manager within the organization, apply superior talent development leadership to ensure Narcolepsy Type 1 PPM team is resourced appropriately to deliver on disease area objectives while having a deep focus on developing team capabilities to enable career growth. Knowledge and Skills: Advanced knowledge of program and portfolio management principles Advanced business acumen to assess the enterprise impact of program scenarios and decisions (business case generation, financials, timeline, resources, risks, etc..) Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources Leadership with superior agility, adaptability, and strategic enterprise mindset Demonstrated ability to navigate ambiguity and drive strategic alignment across disease area and enterprise-level initiatives Excellent written and oral communication skills, including well-developed presentation skills Exceptional organizational skills, an ability to manage multiple priorities Strong collaboration skills to effectively interact with internal and external stakeholders at all levels in the organization Education and Experience: Typically requires a bachelor's degree in Life Sciences or a relevant field Typically requires 12 years of experience and 5 years of management experience, or the equivalent combination of education and experience Comprehensive knowledge of cross-functional pharmaceutical drug discovery, development, and commercialization across multiple disciplines #LI-HYBRID #LI-DB1 Pay Range: $242,200 - $363,300 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
    $242.2k-363.3k yearly Auto-Apply 5d ago
  • Director, GDP Operational Quality (Hybrid)

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    The Director, GDP Operational Quality is responsible to partner with Trade Operations to support the distribution of Vertex's commercial product portfolio. The role is responsible for oversight of team activities, development of personnel and ensuring timely completion and quality of deliverables/goals within their remit. The role supports GDP quality operations for all distribution activities within the US; key stakeholders include Trade Operations, Vendor Quality Management & Quality Compliance. Key Duties and Responsibilities: The responsibilities of this position may include, but are not limited to, the following: Primary quality partner for Vertex US Trade Operations organization, providing quality input and perspective to US Trade Ops continuous improvement initiatives and projects Accountable for ensuring US Trade Ops organisation are operating within the Vertex GDP Quality Management System, accountable to ensure deviations are investigated, recorded in the QMS and CAPAs are identified. Establish robust Quality Processes/Process Ownership for the distribution of Vertex Commercial Finished Goods within the US Responsible for local release activities required to support distribution of Vertex Commercial products Support Trade Operations with Risk Management activities Support the Shipping, Storage & Distribution (SS&D) Process Owners Network (PON). Build, maintain and drive and manage PON activities set out in the SS&D Roadmap Responsible for the Quality oversight and management of Vertex strategic US third party logistics providers : creating and maintaining Quality Agreements, developing KPIs, establishing Quality meetings and participating in governance forums Support inspection preparation and management, prior to, during and following any Authority inspection; Support manufacturing locations as required. Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; recommend mitigation approaches. Participate in New Product Launch activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g., QMS build out, audits, and Quality Agreements. Act as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions. Develop, utilize and continue to mature tools to ensure efficiency in execution of Distribution Quality Processes Qualifications/Requirements/Skills: GDP & GMP work experience, or relevant comparable background. Expert knowledge of International GDP regulations; broad knowledge of GMP and GVP regulations, Knowledge and demonstrated experience in application of risk-based quality principles in a pharmaceutical environment. Demonstrated capability to lead a team through organisational change and a dynamic/ evolving business model. Proven leadership ability to design/evolve and implement quality strategies to support their commercial and supply chain partners in both a clinical and commercial setting. Strong ability to collaborate cross functionally across all levels of the organization with strong communication skills and the ability to persuade others to adopt a new point of view, achieve consensus and negotiate effectively, Highly skilled at managing change, and driving Continuous Process improvements, Highly skilled at time and resource management, prioritization of own work and departmental initiatives, and planning/organization skills, Highly skilled in technical writing, Demonstrates advanced ability to effectively communicate to local, international and global audiences, Significant experience in managing/leading others to include performance management and career development, Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions Demonstrates the Vertex behaviours. Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint). Education and Experience: Bachelors degree in a scientific or allied health field Typically requires 10 years of relevant work experience, or the equivalent combination of education and experience We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work: 1. Hybrid and work remotely up to two days per week; or select 2. On-Site and work 5 days per week with ad hoc flexibility. #LI-AR1 #LI-Hybrid Pay Range: $182,400 - $273,500 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
    $182.4k-273.5k yearly Auto-Apply 57d ago
  • Internal Audit Manager

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    Through internal audits the Internal Audit Manager will identify risk areas, evaluate business process controls and complete test plans on operational audits. Additionally, this role will provide recommendations to improve the effectiveness and efficiency of operations and business systems. This role will also participate in ensuring that the yearly internal control review is brought to fruition by interacting with SOX testers, other stakeholders, and subject matter experts on special projects and the development and execution of departmental goals. Key Duties and Responsibilities: Plans and performs financial, operational and, as applicable, IT audits; reviews related records for compliance with established and relevant reporting policies and procedures and is responsible for the end-to-end execution projects. Applies financial and quantitative analyses and risk assessment procedures, documents findings/work papers in support of departmental goals and objectives Maintains and applies an understanding of generally accepted accounting principles/standards and/or general IT frameworks Identifies and effectively communicates (both verbally and/or in writing) audit results, control weaknesses, accounting/reporting/application deficiencies, process or company risk, business productivity and efficiency opportunities, departmental vision, and any other relevant matters to management or other applicable parties Reviews, appraises and tests the internal controls surrounding business processes to assess compliance with the Sarbanes-Oxley Act Collaborates constructively and respectfully with fellow audit team members and business stakeholders including with multicultural teams and in global locations Maintains communication with the Engagement Director, responds to feedback and adjusts approach as the situation warrants Contributes in management meetings, presents findings, conclusions and recommended actions to business management Knowledge and Skills: Experience within Life Sciences or related sector Excellent organizational and project management skills Excellent written and verbal communication skills Detail oriented, able to multitask and meet deadlines Able to work under general supervision and work collaboratively with diverse teams Expanded knowledge of audit methodology, risk assessment and internal control concepts Ability to analyze process workflows and identify gaps and bottleneck Ability to perform data analytics, SOC1 reviews and understand ITGCs Obtain and provide training to the audit staff to support all aspects of Internal Audit activities to ensure that approved audit objectives are met Ability to operate effectively independently and in a team-oriented, multiple location environment CPA, CIA or CISA certifications or equivalent Education and Experience: Bachelor's degree in accounting/finance/information systems or related field Typically requires 5+ years of auditing experience (Big 4 strongly preferred) or the equivalent combination of education and experience. #LI-DB1 #HYBRID Pay Range: $111,700 - $167,600 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
    $111.7k-167.6k yearly Auto-Apply 19d ago
  • Operational Area Quality Associate Director

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    The Associate Director, GMP Operational Quality is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for primary QA oversight of commercial drug substance manufacturing performed at Vertex's external vendors as well as secondary quality support of commercial drug product manufacturing vendors. This position ensures robust sterile manufacturing controls, commercial supply continuity, support for global jurisdictional expansion, and high‑level combination product quality alignment. The incumbent will mentor team members to provide individual development in addition to efficient and valuable service to project teams. Key Duties and Responsibilities: Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions Oversee CMO/Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement terms Enable team to achieve team goals/objectives and enable their individual career development Develop and maintain compliant quality processes to support GMP activities Oversee the QA support of Change Controls, GMP investigations and associated CAPAs. Performs review and approval of master and executed batch records to support drug substance (DS), drug product (DP), device (Autoinjector) and finished goods (FG) disposition activities Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections. Support review of regulatory submissions, as applicable Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources. Lead and follow up on any QLT action items assigned. Identify and communicate risks and assist with risk mitigation plans as necessary Supports internal audit or external audit programs; assists in preparation of audit responses Provide comprehensive knowledge support for partner and regulatory agency audits Assist management team in budgeting and scheduling Responsible for the following activities related to people management responsibilities: Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding Accountable to provide oversight of day to day team operations Knowledge and Skills: In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing Demonstrated success in building high-performing teams and skilled at managing team and individual development Strong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives Ability to independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unit Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections Supstantial experience with electronic document management systems (e.g., Veeva) Education and Experience: Bachelor's degree in a scientific or allied health field (or equivalent degree) Typically requires 8+ years of work experience and 2 years of management experience, or the equivalent combination of education and experience #LI-hybrid Pay Range: $154,100 - $231,200 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
    $80k-101k yearly est. Auto-Apply 25d ago
  • Director of Financial Planning and Analysis, Biopharmaceutical Sciences and Manufacturing Operations

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    The Director of Financial Planning and Analysis, Biopharmaceutical Sciences and Manufacturing Operations (BSMO) is a key member of Vertex's Financial Planning & Analysis team. This role will partner closely with Commercial Manufacturing and Tech Ops (CMTO), Commercial Finance and Disease Strategy Team (DST) Finance in support of our Cell and Gene Therapies portfolio, with a specific focus on CASGEVY, the first-ever approved CRISPR-based gene-editing therapy used to treat Sickle Cell Disease and Transfusion-Dependent Thalassemia. This role will have the opportunity to work across the organization by providing analysis and insights that will drive key decisions around manufacturing strategy and resource allocation in order to optimize the profitability of CASGEVY. In addition, this position will be an integral part of the BSMO Finance team and play a key role in support of P&L, Capital and Inventory budgeting, forecasting, long range planning, and month-end close processes. This position is based in our Boston, MA location (Seaport area) and requires a hybrid work schedule with 3 days in office /2 days remote on a weekly basis. Key Duties & Responsibilities: Partners with the External Manufacturing, Supply Chain, and Commercial functions to influence CASGEVY business operations and optimize decisions as part of the Sales and Operations Planning (S&OP) process. Identifies ROI/trade-off opportunities to drive profitability and support key decisions around CASGEVY manufacturing and supply chain strategy. Oversees the monthly/quarterly accounting close for expenses and accruals related to CASGEVY Operating Expense and COGS, including flux analysis and compliance with SOX control requirements. Supports analytics and transparent reporting to drive forecast accuracy and inform on key drivers of any variances to plan, with full transparency on any judgments about risks and opportunities for both operating expenses, capital expenses and COGS. Supports the financial planning process (annual budget, forecasts, long range plan, etc.) by providing forward-looking observations and developing key scenarios. Develops and coaches team members to encourage growth and new opportunities and contributes to an atmosphere of inclusivity across the team Works closely with other members of the CFO organization including Commercial Finance, DST Finance, Strategic Sourcing and Accounting to maintain a continuous improvement mindset and promote strong communication, sharing of best practices and efficient processes. Basic Requirements Bachelor's degree in Finance or Accounting required. MBA and/or other advanced degree preferred. 10+ years of relevant experience in finance managerial role, demonstrating strong technical and analytical skills and a track record of success working in a team-based environment or the equivalent combination of education and experience. Experience in business partnering with Manufacturing/Supply Chain executive teams Proven ability to proactively manage efficient processes across Operating Expenses, Inventory and COGS, driving high-quality inputs from the business in support of creating and managing complex budgets, forecasts, and analyses in a dynamic, fast-paced environment. Deep understanding of Biotech/Pharma manufacturing finance to address a broad range of challenges and business issues across all functions with the ability to make and facilitate quick decisions Expert analytical and financial modeling skills to evaluate a broad range of financial questions. Excellent communication and presentation skills, with a proven ability to present complex financial insights to senior stakeholders. Knowledge and Skills: Strategic thinking and problem-solving. Critically, this role requires an expert ability to influence without authority at the highest level and collaborate effectively in support of shared goals. Strong business acumen and judgment, and knowledge of the company's markets/products and industry trends. Expertise with Excel and PowerPoint; Working knowledge of Hyperion or similar enterprise planning tools. Exceptional interpersonal, written, and verbal communication skills Ability to lead and drive change in an evolving business environment, coordinating processes involving large numbers of people, complex systems, and tight deadlines to deliver innovative solutions. Demonstrated ability to lead and collaborate cross-functionally, sharing insights and translating learnings into actionable business initiatives whilst partnering to ensure timely execution of project plans Proactive, organized, and comfortable managing shifting priorities in a rapidly changing environment. Leads with a continuous improvement mindset, with flexibility and ability to adapt to change. Pay Range: $182,400 - $273,600 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
    $182.4k-273.6k yearly Auto-Apply 59d ago
  • Commercial Data Management Associate Director - Pain BU

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    The Commercial Data Management Associate Director serves as the Lead for the Global Healthcare Entity Master (GHEM), Data Management and Quality, Ad Hoc and Recurrent Analytics, and Field Performance Measurement and Reporting across our disease areas. Key Duties and Responsibilities: Acts as an advisor and coach for and collaborates with the governance team(s) Maintains data governance standards, policies, and procedures Monitors data quality scorecards Manages data services vendors Trains internal teams on processes and procedures, including the CRM application Collaborates with Global Information Systems (GIS) team regarding implementation of fixes and enhancements Partners with Sales and Marketing teams to manage and administer content update requests Manages HCP-to-Center affiliations and master data attributes Create reports and dashboards Manages the mobile analytics application Manages the commercial data warehouse (CDW) - vendor communication, business rules and data sources Manages data aggregation vendor - communication, business rules, and data sources Manages patient transaction master data file Monitors data supplier quality - accuracy, timeliness and completeness Reviews data quality scorecards in collaboration with Trade team partners Coordinates sourcing of commercial data - enforces "single version of truth" Partners with Forecasting & Analytics team to deliver weekly performance content to commercial leadership team Responds to ad hoc data inquiries from internal stakeholders Manages mobile iPad sales performance application Coordinates delivery of reports to Sales and Marketing teams Responds to field inquiries and investigations Trains field force teams on reports and business acumen regarding analytics Creates HCP and treatment center segmentation Ensures data accuracy and completeness Owns data library and data governance standards, policies, and procedures Data library and governance ownership Knowledge and Skills: Experience with data vendors, external customers, and field teams Extensive knowledge of master data management (MDM) processes Strong familiarity with CRM, especially Salesforce and Veeva Significant experience with query tools (MicroStrategy, Tableau, Excel) against a database to analyze data quality and content Knowledge of data warehouse architecture, data modeling, and data integration techniques on platforms such as Oracle, Snowflake, Databricks Experience with data vendors, external customers, and field teams Proficiency in Microsoft Office (Word, Excel, Access, PowerPoint Strong analytical, problem solving, and communication skills including ability to communicate effectively across all levels of the organization Education and Experience: Bachelor's Degree required Typically requires 6-8 years of direct experience with pharmaceutical data; sourcing, integration, analysis, and reporting Pay Range: $151,300 - $227,000 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
    $151.3k-227k yearly Auto-Apply 60d+ ago
  • Associate Director Medical Writing (Hybrid)

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    The Associate Director, Medical Writing Science manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. This role applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science department activities with those of other departments. This is a hybrid role which allows for 2 days per week remote work and 3 days per week in the Boston Fan Pier office. We offer a full relocation package. Key Duties and Responsibilities: Independently authors routine and complex clinical and regulatory documents Provides strategic input into program-level plans Deep insight into how different functions contribute to the successes of the team Aligns, coordinates, and builds consistent information and messages across clinical program(s) Provides leadership related to the activities of Medical Writing Science and manages a team Participates in developing and implementing goals and initiatives for Medical Writing Science Facilitates implementation of new technologies and initiatives related to the preparation of clinical documents Proactively anticipates risks, solves complex problems, and seeks out and implements process improvements Knowledge and Skills: Demonstrated aptitude for planning, managing, and optimizing department resources (e.g., staff, technology) to maximize and streamline the advancement of company goals and objectives Record of leadership, independence, and ability to solve non-routine, complex problems involving a broad range of issues Proven track record of anticipating potential problems and preparing contingency plans as needed Understanding of scientific disciplines beyond own specialty area Experience managing direct reports and guiding staff development Experience with marketing authorization application regulatory submissions Education and Experience: Bachelor's degree in relevant discipline Ph.D. (or equivalent degree) Typically requires 8 years of work experience and 2 years of supervisory/management experience, or the equivalent combination of education and experience #LI-AR1 #LI-Hybrid Pay Range: $157,600 - $236,400 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: Remote-Eligible Flex Eligibility Status: 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. 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-Remote 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
    $157.6k-236.4k yearly Auto-Apply 33d ago
  • Director, Strategic Sourcing (Commercial)

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    As a key leader within the Strategic Sourcing function, the individual will be tasked with managing and formulating strategies for Marketing categories to facilitate and enhance commercialization across various disease areas and regions. This role encompasses the oversight of the category life cycle, which includes the development and implementation of multi-year sourcing strategies, in addition to the ongoing management of strategic supplier relationships and performance evaluation. In partnership with Business Units and Finance, this position will be tasked with setting category objectives and will assume complete responsibility for their implementation. You will assist in the ongoing management of essential strategic suppliers to promote continuous improvement, address complex challenges, and uncover new opportunities that deliver outstanding value to Vertex and, ultimately, our patients. You embody a commitment to lifelong learning, demonstrating a strong sense of curiosity and adaptability, while consistently seeking to broaden your expertise beyond your immediate remit as part of your personal development. This position is highly visible throughout the organization and you are a leader who is comfortable, adept and effectively communicates with Senior Executive leaders. This position is based in our Boston, MA office, located in the Seaport area. This role requires a hybrid work schedule: 3 days in office & 2 days remote on a weekly basis. The role is global and will require some travel to all other facilities and locations (including London) to establish / maintain key business stakeholder relationships. Key Responsibilities: Strong business partnering acumen to develop trusting and influential relationships with stakeholders, understand business objectives and challenges, bring supplier and marketplace expertise, collaborate on multi-year strategic and operational plans, and drive business outcomes. Develop, implement, monitor and maintain category strategies in partnership with Business stakeholders for all related sub-categories, including continuous refreshment and improvement of category strategies to meet evolving business needs Own the Supplier Performance/Relationship Management process including supplier performance monitoring. Responsible for meeting preparation, pre-read documents, performance dashboards, capturing action items, and ensuring appropriate follow-up including Executive Business Reviews In collaboration with the Business, responsible for defining Key Performance Indicators (KPIs) and associated performance metrics and are integrated into contractual documents and captured on Dashboards to ensure supplier performance is meeting expectations and continuously improving Support the Business Owner with identification of all applicable risks as part of the Sourcing process, including coordination with Risk Subject Matter Experts to properly assess and develop mitigation plans, where necessary Manages complex negotiations on price and terms, that often include other internal stakeholders such as Business Partners and Legal. Able to independently create comprehensive negotiation planners that all internal parties are aligned with upfront Acts as mentor to support Sourcing colleagues, temporary workers, and/or college co-ops, as directed by their manager Required Education, Experience and Competencies: Bachelor's Degree and MBA required 10+ years of strategic sourcing experience including relevant Marketing Procurement experience Good understanding of the nuances associated with a regulated environment AI-ready mindset, passionate individual about AI opportunities and overall impact in Services area Embody a Can-Do- Mindset, thriving in ambiguity, while building bridges thanks to innovative solutions Strong analytical capabilities | Project management skills | Good communication and presentation skills, able to clearly articulate opinions in concise and persuasive manner Excellent communication and organizational skills. Comfortable interfacing and presenting to senior leadership in a concise, well-planned manner. Pay Range: $175,200 - $262,800 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. 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
    $175.2k-262.8k yearly Auto-Apply 60d+ ago
  • Global Trial Associate- Global Clinical Operations Leadership Development Program (GCO-LDP)- Full-Time Class of 2026

    Johnson & Johnson 4.7company rating

    Remote or Los Angeles, CA job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: Irvine, California, United States of America, Los Angeles, California, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine Remote work options may be considered on a case-by-case basis and if approved by the Company. We are searching for the best talent for the Global Trial Associate- Global Clinical Operations Leadership Development Program (GCO-LDP)- Full-Time Class of 2026. Purpose: The GCO Leadership Development Program consists of 12 months of dynamic rotations in Spring House, PA and Southern California locations (e.g Los Angeles, Irvine, San Diego). The Program provides in-depth training across the Clinical Trial Assistant, Site Manager, and potentially Local Trial Manager based on business need, supported by strong line management, formal mentorship, sponsorship, networking, focused leadership development and dynamic real world work experience. Global Trial Associates (GTAs) will rapidly gain knowledge, develop technical and leadership skills and important insights into how the business operates. These positions will be in the Immunology and Cross (e.g. Neuroscience, Retinol, and others) Therapeutic Areas. These positions will not be in the Oncology Therapeutic area. The objective is for the GTA to develop an understanding of pharmaceutical development, GCO standard operation procedures, policies and regulatory requirements, logistical and administrative tasks related to trial management (start-up, execution and closing phases) and patient safety in clinical trials. The GTA will gain knowledge of and support activities of the Site Manager (SM) and Program Manager, and/or Manager Clinical Operations (MCO). GTA's will support Local Trial Manager (LTM) positions under the direct supervision of LTM and SM mentors if there is a business need. Upon successful completion of the program, GTAs will be placed in a Site Manager role or potentially a Local Trial Manager role depending on business need and skillset. The GCO US Site Management organization is regionally aligned to the Northeast, Southeast, Central and West. This reduces the travel burden for Site Managers as they are assigned to study institutions based in their region. Local Trial Managers work remotely and are not regionally aligned as they don't have travel associated with their position. LTMs are project managers responsible for study deliverables in the US. Following completion of the program, GTAs moving into the SM role will work remotely in an assigned region in the U.S., where there is a business need. You will be responsible for: * Provide administrative and logistical support to Clinical Trial Assistant (CTAs), Site Manager and/or Local Trial Manager in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies, and local regulatory requirements. * Support the local study team in performing site feasibility and/or country feasibility. Collaborates with the Global Project Team, e.g. Trial Delivery Manager (TDM)/Trial Delivery Lead (TDL), local management/Country Head and other study team members, as required. * Maintain information in relevant systems, including electronic filing (electronic Trial Master File: eTMF). * Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable. * Support Trial Delivery Manager, Site Manager and/or Local Trial manager in collecting/preparing documents required for study start-up/ submission to Ethics Committee/IRB and/or Health Authorities. * Support Trial Delivery Manager, Site Manager and/or Local Trial Manager in collecting, processing, and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones. * May assist team in conducting local investigator meeting or with planning for the investigators participating in an international meeting. * Maintain and update contact information in relevant systems to ensure appropriate safety updates distribution. * Comply with all training requirements, company policies & procedures and all applicable laws and regulations. Always act aligned with J&J Credo. * Ensure inspection readiness at all times. * May contribute to process improvement. * Support Site Manager, within a reasonable timeframe, be able to take on responsibility in executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/ study close-out according to Standard Operating Procedures, Work Instructions (WIs) and policies. Qualifications / Requirements: * Must be graduating between December 2025 and July 2026 with a bachelor's or master's degree (e.g., BA, BS, MS) in Health Sciences or a related scientific field (we will not be accepting PhD/Pharm D or Pre-Med applicants) * Minimum GPA of 3.5 is required * 1+ year of professional work experience is preferred (including internship, co-op or research experience) * Ability to relocate to: * Spring House, PA and work full-time (hybrid 3 days on-site/2 days remote) for the duration of the 1-year program * California locations and work full-time for the duration of the 1-year program (hybrid and/or remote schedule will be determined on an individual basis) * Geographic flexibility to relocate within the U.S. following completion of the program, if there is a business need * Ability to travel as needed in the Site Manager rotation * Permanently authorized to work in the United States, must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship. Skills: * Strong verbal and written communication and presentation skills * Analytical and a real problem solver * Willingness to learn in a dynamic environment and stay abreast of new technologies * Strong interpersonal, leadership, and negotiating skills * Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. * Ability to perform activities in a timely and accurate manner. * Expert proficiency with Word, Power Point, Excel. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: * Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. * Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). * This position is eligible to participate in the Company's long-term incentive program. * Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to: ********************************************* Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. #LI-Hybrid #LI-Remote #LI-Onsite Required Skills: Analytical Thinking, Microsoft Excel, Negotiation, PowerPoint Presentations, Problem Solving, Time Management Preferred Skills: Analytical Reasoning, Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials The anticipated base pay range for this position is : $95,600/year Additional Description for Pay Transparency: This position is eligible for a sign-on bonus. Eligibility for severance.
    $95.6k yearly Auto-Apply 14d ago
  • Portfolio & Program Management Senior Director

    Vertex Pharmaceuticals, Inc. 4.6company rating

    Remote or Boston, MA job

    The Portfolio & Program Management Senior Director is a global role within the Portfolio & Program Management (PPM) organization. This role is a key leadership position providing strategic and operational program management leadership to the Narcolepsy Type 1 (NT1) Disease Strategy Team (DST). The incumbent is responsible for championing cross-functional program management excellence to programs across the drug development lifecycle (Research, Pre-clinical and Clinical Development, Registration and Commercialization). The incumbent is expected to apply deep subject matter expertise in program management to identify opportunities, shape objectives and drive execution of global strategies for cross-functional drug development and commercialization teams. Key Duties and Responsibilities: * Provide strategic and operational program management leadership to the Narcolepsy Type 1 Disease Area Executive (DAE), Disease Strategy Team (DST) and cross-functional teams, directing activities at all stages of the program lifecycle (initiation through closeout) * Drive communication cross-functionally and with senior leaders on integrated program planning topics including timelines, status, risks and interdependencies across a complex portfolio of pipeline programs. * Proactively identify roadblocks and/or constraints impacting strategic imperatives or program execution and lead the team through scenario planning activities * Partner with governance forums, senior leaders and/or team lead(s) to align strategy, goals and milestones with corporate objectives * Propose innovative approaches, define process improvements and advise leaders on opportunities to optimize program results * Determine approach and stakeholders for cross-functional decision-making and issue resolution * Oversee completion of disease area deliverables and contribute to content development, when appropriate * Establish project team operating norms and measure performance * As a potential people manager within the organization, apply superior talent development leadership to ensure Narcolepsy Type 1 PPM team is resourced appropriately to deliver on disease area objectives while having a deep focus on developing team capabilities to enable career growth. Knowledge and Skills: * Advanced knowledge of program and portfolio management principles * Advanced business acumen to assess the enterprise impact of program scenarios and decisions (business case generation, financials, timeline, resources, risks, etc..) * Leadership experience managing cross-functional teams with an ability to influence teams to prioritize activities and allocate resources * Leadership with superior agility, adaptability, and strategic enterprise mindset * Demonstrated ability to navigate ambiguity and drive strategic alignment across disease area and enterprise-level initiatives * Excellent written and oral communication skills, including well-developed presentation skills * Exceptional organizational skills, an ability to manage multiple priorities * Strong collaboration skills to effectively interact with internal and external stakeholders at all levels in the organization Education and Experience: * Typically requires a bachelor's degree in Life Sciences or a relevant field * Typically requires 12 years of experience and 5 years of management experience, or the equivalent combination of education and experience * Comprehensive knowledge of cross-functional pharmaceutical drug discovery, development, and commercialization across multiple disciplines #LI-HYBRID #LI-DB1 Pay Range: $242,200 - $363,300 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
    $242.2k-363.3k yearly Auto-Apply 8d ago
  • Director, Accounting Systems & Consolidation (Hybrid)

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    Vertex is seeking a hands-on, experienced consolidations leader with accounting systems and process expertise to join our Global Accounting organization. The Director, Accounting Systems & Consolidation will oversee the global close and consolidation process and drive accounting system and financial reporting excellence. In addition, the Director will closely partner with IT and other stakeholders to maintain and enhance our key accounting systems and applications such as HFM, Oracle EBS, and Blackline. This newly established role is ideal for a motivated leader who can effectively lead our small team of experienced professionals to align diverse stakeholders, foster collaboration, and deliver innovative solutions to advance our consolidation processes and accounting systems. Key Duties and Responsibilities: Drive process excellence for the monthly, quarterly, and yearly close and consolidation process, working closely with the appropriate stakeholders (global accounting, tax, treasury, finance and shared services) to ensure timely and accurate financial results Develop and execute strategy for various consolidation initiatives, such as intercompany automation, cloud-based applications, and RPA bots Partnering with Vertex's IT organization, maintain and support our key accounting systems and applications such as HFM, Oracle EBS, and Blackline, including change management for upgrades and enhancements Collaborate with global partners to formulate enhancement options to address specific functional issues/requirements Manage and oversee completeness and accuracy of system eliminations for intercompany balance sheet and income statement activity Develop and monitor metrics and key performance indicators that drive best practices Assist in the development of the overall Accounting Systems roadmap Effectively lead team of 4 experienced professionals; mentor, develop, retain and recruit high potential talent Knowledge and Skills: Expertise with complex integrated financial reporting systems, inclusive of HFM, Hyperion ESSbase and Oracle EBS Knowledge of financial consolidation, accounting for intercompany and foreign currency translations, eliminations, reporting for monthly and quarterly closes, general ledgers, hierarchies and data structures Direct management of governance and finance system compliance in accordance with company policies, standards and SOX requirements Strong systems mindset and understanding of accounting system workflows Applies knowledge and understanding of financial and US GAAP accounting principles to systems and business processes Ability to interact and partner with all levels of management to help drive collaborative business decisions Possesses interpersonal and organizational skills, high energy level and strong work ethic Able to anticipate change and respond to client priorities, demonstrating a “can do” attitude Excellent written and verbal communication skills including the ability to succinctly convey relevant information across multiple levels of the organization Finance process excellence or Six-Sigma experience a significant plus Education and Experience: Bachelor's degree in either Accounting, Finance, Information Technology, Business or a related field Typically requires 10+ years of experience in finance or accounting with a large, complex, multinational organization Big 4 experience and life science industry experience is preferred CPA or equivalent certifications are desirable A track record of success working in a team-based environment Pay Range: $173,600 - $260,300 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
    $173.6k-260.3k yearly Auto-Apply 60d+ ago
  • Meetings & Events Senior Planner

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    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
    $91.2k-136.8k yearly Auto-Apply 60d ago
  • Biostatistics Associate Director (Hybrid)

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    The Associate Director, Biostatistics will perform sophisticated scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with minimal guidance and mentoring on new and complex issues. The incumbent will completed work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results. The incumbent is capable of independent strategic and technical contributions. The incumbent should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset. Key Duties and Responsibilities: Conducts all scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations. Leads biostatistics projects or major components of a project including work allocation and review. May include presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards. Possesses an advanced and in-depth understanding of modern drug discovery and development processes. Represents Biostatistics as a member of cross functional teams, providing input and specialized technical guidance to elicit meaningful and/or productive outcomes. Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) in order to facilitate the review, summary, and dissemination of key study data/results. Knowledge and Skills: In-depth competence with SAS and R statistical software In-depth understanding of advanced statistical methods used in drug development Ability to show critical thinking with logical problem-solving Excellent written and verbal communication skills Excels in a team environment Collaborates well with non-statisticians NDA/MAA experience and direct dealings with USA/European regulators Education and Experience: Ph. D. or master's degree in Statistics or Biostatistics. Typically requires 7 years of experience with a Ph.D. #LI-AR1 #LI-Hybrid Pay Range: $164,800 - $247,200 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. 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
    $164.8k-247.2k yearly Auto-Apply 60d+ ago
  • Global Marketing Director - Pove

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    Povetacicept is a pipeline in a molecule with a potential to transform treatment outcomes for patients. The Director, Global Marketing of Povetacicept is accountable for key indications understanding the market landscape and Vertex's position within the market, actively contributing to defining the strategy and performance goals of the portfolio and tracking performance against those goals. Key Duties and Responsibilities: Develops the indication strategy for povetacicept for key indications, and oversees creation of brand strategies and lifecycle activities including launch planning and prioritization Oversees development and implementation of strategic and tactical plans working across functions for a unified indication plan Provides input into forecasting assumptions, both short term and long term Generates and consolidates key insights across HCPs and patient stakeholders (through market research, ad boards, etc.) Leads the development of strong partnerships with cross-functional team to support business goals including R&D and regional teams Knowledge and Skills: Experience defining the strategy for a brand or portfolio of products with multiple indications/pipeline in a product Ability to oversee generation of insights, and apply those insights to business problems/opportunities Analytical mindset, with demonstrated ability to develop strategy, make strategic recommendations, monitor performance, understand ROI and allocate resources Exceptional working knowledge of market forecasts and relationship of business drivers to revenue Experience in pharmaceutical marketing. In-market and /or global marketing experience required. Neurology experience preferred. Education and Experience: Bachelor's degree in marketing, business, or scientific degree Typically requires 12 years of experience or the equivalent combination of education and experience Pay Range: $195,200 - $292,800 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. 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
    $195.2k-292.8k yearly Auto-Apply 60d+ ago
  • Director, Data Governance & Engineering, Research

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    Vertex is in an exciting time of growth and innovation, and technology and data are valued as strategic assets. We're seeking a visionary Director of Engineering and Data Governance to lead the strategy, planning, and governance of data and custom software solutions for our research, pre-clinical teams, and manufacturing teams. Reporting to the Sr. Director of DSE (Data & Software Engineering) Governance, you will drive innovation, ensure data quality, and enable impactful research through cutting edge data & AI products. This is a high-visibility leadership role with significant influence on Vertex's scientific and business outcomes. Your expertise in understanding engineering capabilities, managing engineering demand, estimating engineering projects, communicating project and function status, and driving governance and standards will be crucial in directing our engineering staff to deliver and support high value business-driven data and software at the right time, with approved resources, and with high quality. Key Duties & Responsibilities Partner with DTE Leadership to develop and execute data and analytics strategy aligned to the research and manufacturing business strategy and develop data and analytics roadmaps to enable the data strategy. Collaborate with cross-functional leaders to identify and deliver high-impact data and software solutions. Oversee the management, documentation, use, and quality assurance processes for prioritized data projects and data assets, including proprietary data sets, third party data, research and pre-clinical data. Establish and enforce data governance standards, frameworks and best practices. Collaborate with stakeholders to define project goals, deliverables, timelines, budgets, and resource requirements. Collaborate with resource managers to source, allocate and assign internal or contingent workers to project and operational activities Monitor project progress, manage risks, and communicate status to senior leadership. Collaborate with cross-functional DTE and business teams, including portfolio management, privacy, security, business engagement, DCS (Data and Computational Sciences), data science teams and HR to ensure data and software development needs are understood and solutions are aligned with prioritized business objectives. Foster a culture of innovation, continuous improvement, and accountability. Knowledge and Skills: Strong knowledge and experience with leading and managing data, AI/ML, reporting and analytics projects and assets for the research, pre-clinical, and manufacturing domains in the biopharmaceutical industry. Knowledge and experience in the research functional area and the related business processes and data. Strong understanding of data management, data governance, data architecture, software engineering, and cloud computing Strong communication and presentation skills, with the ability to communicate technical and non-technical topics to senior leaders and engineering teams. Proven ability to serve as a control function and enforce annual planning agreements by finding ways to say “yes” to prioritized commitments and “no” to lower priority requests Strong understanding and awareness of data privacy, data security and compliance to relevant rules including GxP regulations. Strong knowledge of modern technologies like AI/ML, LLMs, cloud computing, cybersecurity, data platforms like AWS, Snowflake and Databricks Strong project management and resource planning skills. Excellent communication and stakeholder management abilities. Experience with Agile methodologies. Education and Experience Bachelor's degree required (preferably in a technology or engineering discipline). 10+ years' experience working in growing technology roles with at least 6 years in IT leadership positions. 6+ years' experience in a similar governance, planning, or strategy role with a focus on bio pharma #LI-HYBRID Pay Range: $184,000 - $276,000 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
    $184k-276k yearly Auto-Apply 60d+ ago

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Alnylam Pharmaceuticals may also be known as or be related to Alnylam Pharmaceuticals, Alnylam Pharmaceuticals Inc, Alnylam Pharmaceuticals Inc. and Alnylam Pharmaceuticals, Inc.