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Ironwood Pharmaceuticals jobs in Boston, MA - 111 jobs

  • Senior Director, Medical Writing

    Ironwood Pharmaceuticals 4.7company rating

    Ironwood Pharmaceuticals job in Boston, MA

    Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant unmet medical need. These conditions are challenging to diagnose, often devastating, and have limited, if any, treatment options. The lead product candidate, apraglutide, is a next-generation, best-in-class, synthetic peptide analog of glucagon-like peptide-2, or GLP-2, and is in Phase 3 for the treatment of patients with short bowel syndrome, or SBS, a malabsorption disorder caused by the loss of functional small intestine. It is an exciting time to join as Phase 3 is underway and the company is preparing for an initial launch in the coming years for which it is building out a commercial presence. The Senior Director of Medical Writing will have responsibility for executing a fit-for-purpose delivery model to produce a range of high quality clinical and regulatory documents to advance company goals across all investigational and marketed products. To achieve that aim, the Senior Director will collaborate with stakeholders across the Research & Development organization to understand priorities and needs. The Senior Director will initially oversee the selection and operation of external vendors and may eventually build an internal team to resource projects. The Senior Director will lead the development of processes and initiatives to ensure the consistent delivery of high quality, efficient medical writing services that comply with regulatory and internal guidelines. The Senior Director will represent the medical writing function on cross-functional teams for marketed and/or investigational products. The Senior Director will independently deliver clinical and regulatory documents that span the drug development lifecycle. The Senior Director will ensure high quality with regard to compliance with regulatory and internal guidelines, and the accuracy, consistency, and organization of documents. The Senior Director must be a proactive leader, effectively able to organize and collaborate with cross-functional teams to produce on-time, on-target documents that further the program goals. The Senior Director must have a strong understanding of drug development, clinical research concepts and data interpretation and presentation. Responsibilities: Maintain a long-term project forecast and resource plan to deliver all the documents required to advance company goals. Manage the selection of external vendors, from the initial preparation and review of completed Requests for Proposals through to contract negotiation and finalization. Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents. Manage the ongoing operations of high performing external vendors, including resource forecasting, contract change management, of oversight of vendor financials. Drive the ongoing development of processes, initiative, and tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines. Serve as a subject matter expert, advising and collaborating with cross-functional stakeholders on document strategy, authoring and review processes, and best practices. Represent Medical Writing and provide medical writing expertise on cross-functional teams. Develop detailed timelines for document development in line with company goals and SOPs. Write clinical and regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures. Documents include, but are not limited to, clinical study protocols, clinical study reports, Investigator's Brochures [IBs], and Module 2 summaries of registration dossiers. Manage multiple rounds of team review through document finalization (ie, distribute documents for review; consolidate and resolve of reviewer comments; lead efficient cross-functional review roundtables). Ensure the accuracy, consistency, and quality of documents. Coordinate a formal quality control (QC) review of documents, as applicable. Coordinate with the Regulatory Operations team to publish documents that meet eSubmission‑ready standards. Collaborate with Data Sciences to review statistical analysis plans to ensure that the outputs planned meet data reporting needs and document templates. Lead the preparation of public disclosures of study results on national registries such as ClinicalTrials.gov and EU Clinical Trials Information System (CTIS), ie, coordinate with the external vendor to prepare the posting, distribute the posting for review, perform a quality control review [QC], consolidate and resolve reviewer comments, coordinate the redaction of required documents, notify the relevant stakeholders, in accordance with the company SOP and relevant regulations. Collaborate effectively across Ironwood and with Ironwood partner companies and external vendors, as applicable. Participate in the development of department SOPs and process-related tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines. Support medical writing and other cross-functional colleagues as necessary (eg, document review, format, and QC). Qualifications: BA/BS and 12+years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferred Success in managing resources (internal, external, or hybrid) Prior direct experience leading medical writing teams responsible for global marketing authorization applications Experience with a broad range of clinical regulatory documents spanning the drug development lifecycle Strong understanding of the drug development process, including regulatory requirements and ICH/GCP/eCTD guidelines. Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology Excellent technical writing and editorial skills; excellent attention to detail Strong ability to understand and interpret medical and scientific data Proficient in Microsoft Word, PowerPoint, Excel, Project, and SharePoint Experience with automated document templates (eg, StartingPoint by Accenture), Adobe Acrobat and EndNote Excellent communication, interpersonal, and organizational skills Experience working on cross-functional teams Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines Ironwood currently anticipates that the initial base salary for this position could range from between $239,000 to $278,565. The actual base salary will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule. #LI-Hybrid
    $239k-278.6k yearly Auto-Apply 60d ago
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  • Strategic External Scientific Partnerships Lead

    Astrazeneca 4.6company rating

    Boston, MA job

    A leading biopharmaceutical company in Boston seeks an Associate Director for External Scientific Partnerships. This position drives strategic engagement with health professionals and organizations in the rare disease sector. Candidates should have a PhD or equivalent, alongside 3-5 years of relevant experience, strong leadership, negotiation, and project management skills. The role offers competitive pay, benefits, and a commitment to an inclusive workplace. #J-18808-Ljbffr
    $142k-233k yearly est. 3d ago
  • Head of Statistical Programming & Submissions

    Astrazeneca 4.6company rating

    Boston, MA job

    A leading pharmaceutical company in Boston is seeking a Director of Statistical Programming to oversee statistical programming activities across multiple clinical studies. The candidate will be responsible for managing team and project resources, ensuring compliance with quality standards, and implementing programming specifications. Applicants should possess prior experience in the CRO or Pharmaceutical Industry, strong SAS programming skills, and excellent management capabilities. This role offers a dynamic work environment and opportunities to shape project outcomes. #J-18808-Ljbffr
    $95k-122k yearly est. 1d ago
  • Director, Safety Scientist

    Astrazeneca 4.6company rating

    Boston, MA job

    The Director, SafetyScientist plays a leadership role within Global Patient Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework. You will be responsible for: Leading risk management evaluation and resolution for assigned products and projects. Accountability for the following: Proven skill set for strategic leadership in a cross functional matrix Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications Co-lead activities related to new drug applications and other regulatory filings Represent global patient safety at regulatory inspections i.e. MHRA, FDA, EMA, etc. Lead analysis to identify and address changes in global regulations including updates to SOP and process documentation Leading activities to identify and address process gaps Responsible for vendor management and training including budgets Responsible for overall project distribution across therapeutic area As needed represent GPS in global program teams and associated cross functional teams and/or projects Proactively provide guidance and educational training to GPS therapeutic teams Participate in ongoing safety data review and analysis for products in designated therapeutic areas. Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors. Responsible for project managing and authoring of safety documents including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requestsin collaboration safety physicians. Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position. Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products. You will have: Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years' experience in drug safety and risk management within the pharmaceutical, biotech or CRO industry Knowledge and understanding of US and EU safety regulations pre- and post- marketing Experience with Risk Management and Minimization programs Experience preparing post marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans Experience with clinical development including risk/benefit analysis and safety assessment Strong clinical, analytical, problem solving and scientific writing and communication skills We would prefer you have: Expertise with clinical and safety databases Experience in MedDRA coding and search strategies Excellent, independent judgment based on knowledge and expertise Strong personal time-management and project-management skills Mastery of Microsoft Word, PowerPoint and Excel The annual base pay for this position ranges from $175,000 to $263,000. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 02-Dec-2025 Closing Date 16-Dec-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. #J-18808-Ljbffr
    $175k-263k yearly 2d ago
  • Strategic Planning & Execution Lead - US Medical Affairs

    Astrazeneca 4.6company rating

    Boston, MA job

    A leading biopharmaceutical company is seeking an Associate Director of Strategic Planning & Execution to drive strategic initiatives and ensure project delivery in a timely manner. The ideal candidate will have a Bachelor's degree and at least 7 years of experience in the pharmaceutical industry, with strong leadership and project management skills. This role offers a competitive salary range of $150,202 - $225,304 and opportunities for bonuses and comprehensive benefits in a dynamic work environment. #J-18808-Ljbffr
    $150.2k-225.3k yearly 4d ago
  • Senior Medical Science Liaison - Nephrology (Michigan: East)

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA job

    Senior Medical Science Liaison - Nephrology (Michigan: East) page is loaded## Senior Medical Science Liaison - Nephrology (Michigan: East)locations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-26679**Job Description****General Summary:**The Senior Medical Science Liaison (Sr MSL) (Nephrology) for Povetacicept programs. Povetacicept (pove) is an enhanced, dual BAFF/APRIL inhibitor in pivotal development for the treatment of IgA Nephropathy (IgAN).The Sr MSL will serve as a scientific liaison to the medical/academic community and is responsible for establishing and maintaining relationships with Health Care Providers/Professionals (HCPs) to ensure the appropriate dissemination of clinical and scientific information regarding Vertex' compounds in a timely, ethical and stakeholder-focused manner. The Sr MSL will contribute to shaping the medical plan by providing external stakeholders' insights and contribute to the designing and execution of the Medical Affairs strategy and plan. The Sr MSL will engage HCPs in response to scientific educational and research needs with available Vertex resources and provide the latest emerging data in response to specific inquiries, as appropriate.**Key Duties and Responsibilities:*** Develops and fosters effective and trusting relationships with Thought Leaders (TL) and identifies and engages other appropriate HCPs resulting in scientific engagement with a large network of T1D and transplant-team care providers and opinion leaders. Additionally, understands the inter-relationships both within and between academic centers and utilizes this expertise to enhance Thought Leader and HCP engagements* Consistently incorporates all aspects of the SEM (Scientific Engagement Model) into all interactions, enhancing the quality of interactions and overall relationships as assessed by field coaching observations* Independently incorporates the medical plan into interactions and territory planning (i.e. listening priorities) and captures valuable feedback in the CRM system to inform internal stakeholders and assist in shaping the medical strategy* Possesses an in-depth understanding of the utility and functionality of the CRM system/data analytics tools, allowing for the time sensitive capture of interaction details. Uses CRM/Analytics to enhance future TL engagements and manage workload* Discusses scientific information effectively and compliantly with external stakeholders at an advanced level of communication for both disease state and product to external stakeholders as assessed by management coaching and field observations* In-depth conceptual and practical knowledge of payers in the region and possesses an in-depth understanding of the impact of payers on patient care delivery* Assists clinical development/clinical operations by fully understanding IB content and presenting IB material, providing nominations for trial sites as requested, providing end of study data reviews with investigators (as needed)* Represents Vertex at medical congresses by providing scientific session/abstract coverage, booth staffing coverage, routine TL interactions, contributing to the daily and end of congress summaries and may provide logistical guidance through organizing and scheduling abstract/session coverage and preparing and delivering the conference debrief (as needed)* May serve as a mentor or trainer for colleagues with less experience; for example, assisting with new hire MSL onboarding* Conducts all activities in compliance with Vertex policy and procedures and performs all administrative tasks in a timely manner such as CRM entry, vehicle mileage reporting, expense reporting, calendar entries, training assignments, etc.**Knowledge and Skills:*** Ability to complete goals within allotted timeframes, and deliver high quality results* Ability to help plan and complete projects in a constantly changing field-based environment* Ability to appraise and comprehend medical and scientific literature* Ability to effectively present clinical/scientific information in a credible manner in varied settings* Good knowledge of assigned geographic territory* In-depth understanding of healthcare regulatory environment* Apply proficient knowledge of relevant T1D and T1D management protocols, healthcare environment and landscape to articulate the medical and scientific value of our products* Demonstrated working understanding around the compliance and regulatory frameworks that govern the pharmaceutical industry and conducts compliant interactions with internal and external stakeholders.* In-depth knowledge of payers and unique medical information needs to support access and appropriate use of Vertex medicines* Good knowledge of Health Economics and Outcomes Research* Fluent in English (oral and written)**Education and Experience:*** Minimum requirement for advanced biomedical or life sciences degree (ex. Masters, NP, PA)* Requires minimum of 3-4 years of experience as an MSL supporting Nephrology programs or in other medical affairs roles in the pharma/biotech industry or the equivalent combination of education and experience.* Previous training or experience in designated therapeutic area is helpful Pay Range:$171,300 - $245,000Disclosure 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.**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com. #J-18808-Ljbffr
    $171.3k-245k yearly 2d ago
  • Director, Patient Services - Quality & Compliance

    Astrazeneca 4.6company rating

    Boston, MA job

    A leading biopharmaceutical company is seeking a Director of Patient Services Quality and Compliance to ensure excellence in their Patient Support Programs. This pivotal role involves overseeing quality processes, leading initiatives for data integrity, and managing compliance with regulatory standards. Ideal candidates will have over 8 years in Patient Services, a relevant Bachelor's degree, and demonstrate strong leadership and stakeholder management skills. The position promotes both innovation and collaboration within a diverse work environment. #J-18808-Ljbffr
    $151k-194k yearly est. 2d ago
  • Strategic Operations Lead, US Market Access

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA job

    A global biotech company is seeking an Associate Director for Strategy and Operations in Boston. This role supports the US Market Access Leadership Team, driving strategic initiatives and operational execution. The ideal candidate will have over 8 years of experience, strong communication and collaboration skills, and a Bachelor's degree. The position offers a hybrid or on-site work model and competitive compensation ranging from $155,700 to $233,600 annually, with additional benefits such as educational support and paid time off. #J-18808-Ljbffr
    $155.7k-233.6k yearly 4d ago
  • GMP Quality Associate Director - Operations & Compliance

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA job

    A leading biotechnology company in Boston is seeking an Associate Director, GMP Operational Quality to ensure compliance and quality oversight for commercial drug manufacturing. The role includes managing relationships with vendors, mentoring team members, and leading quality improvement initiatives. Candidates should possess strong knowledge of cGMPs, a scientific degree, and extensive experience in quality assurance and project management. This position offers a hybrid work model and competitive compensation package. #J-18808-Ljbffr
    $80k-101k yearly est. 1d ago
  • Project Management & Strategic Operations Director

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA job

    Project Management & Strategic Operations Director page is loaded## Project Management & Strategic Operations Directorlocations: Boston, MAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-27588**Job Description****General Summary:**The Project Management & Strategic Operations Director - Clinical Development serves as the end-to-end program lead for large-scale strategic programs of high business value. Drives benefit achievement by leading program initiation, planning, solution design and build, and by measuring key performance indicators and solution adoption. Engages other colleagues/resources and assigns appropriate responsibilities to support achievement of program roadmap and project plan(s). Independently applies expert knowledge of advanced methodologies, selecting and applying high-level project management tools to conduct analyses, reporting and related activities for assigned projects. Contributes to the development of internal protocols and processes used to carry out program management work. Responsible for program management activities including contingency/dependency tracking, status reporting, issue/risk identification and tracking, scope management, estimation, and internal/external stakeholder management. Provides oversight to workstream/task leads within the program; resolves any escalated project risks, issues and dependencies. Manages the overall scope and timing of the program, ensuring on-time and within budget delivery.This role will serve an important role in the Global Clinical Development organization to improve focus and alignment across programs and ensure greater organizational effectiveness. Responsibilities will include working with other functions within Vertex to obtain accurate, up-to-date plans and metrics across all clinical development programs to ensure visibility and alignment, including study milestones, enrollment metrics and budgets.**Key Duties and Responsibilities:*** Organizing, driving and managing the Clinical Development deliverables in terms of timelines, budget and communication.* Serve as a strategic partner to the SVP, Clinical Development; create and run reports, create presentations, draft communications documents, serve on cross-functional strategic initiatives representing Clinical Development.* Support the SVP, Clinical Development in creating, communicating and tracking annual goals* Partner with Clinical Development Execution group to use the clinical operations systems to track study enrollment across programs vs target and translate the information to make it relevant and user friendly for Clinical Development.* Work with finance, clinical development execution team and medical directors to track study budgets across programs vs target* Collaborate with regulatory team to use the regulatory systems to track upcoming regulatory meetings and briefing documents (drafts/review schedule etc) and translate to make this information to make it relevant and user friendly for Clinical Development* Run the TA review meetings including meeting minutes, tracking and archiving submissions and decisions* Drive executional excellence in terms of timelines, sign-offs, submissions to internal governance (eg protocols, CSRs, etc) and external postings like clinical trials.org* Support onboarding, compliance/SOP training and tracking, team effectiveness* Lead communications within the Clinical Development team including updates within the team, to cross-functional partners including those ex-US, and bring relevant communications from the broader organization in to ensure the Development area are aware and prepared* Oversees end-to-end program management activities for large-scale, strategic programs of high business value, with oversight for the full project lifecycle* Manages the progress and contributions of workstream leads or subordinate project managers to ensure all activities deliver expected value within committed timeframes and budget* Manages contingencies between multiples projects and monitors interdependencies and synergies where required* Builds and synthesizes highly-detailed project plans, budgeting & forecasting models or resource plans, requiring significant stakeholder management skills and interpretation of diverse and varied information* Develops statements of work, stakeholder management plans, guiding principles, project goals, risks, resource allocation, and roles and responsibilities for assigned projects* Secures, leads, motivates and inspires the internal and external resources required to effectively deliver the program. Establishes the program's governance (e.g., sponsors, approvers, stakeholders)* Participates in the evaluation, selection and management of external resources or vendors* Provides transparency in project progress and effectively anticipates and mitigates major risks across the project lifecycle* Proactively crafts feasible solutions to combat risks and issues. Exercises sound judgement balancing risks and making prompt decisions in ambiguous or difficult situations* Manages communication with management at a detailed functional level and discusses/resolves issues* Works with all required functions and groups to effectively plan and execute the program/project(s). May coordinate resources across organizational boundaries* Trains and coaches project teams in execution methodologies and promotes adoption of best practices* Develops tools and training methods to enable successful project management throughout the enterprise. Ensures project delivery is in conformance with company methodologies and standards; recommends improvements and changes as necessary* Evaluates program costs and benefits including actual results and forecasts with comparisons to original or baseline plan and updates plans with accurate, up-to-date information in a timely manner. Reports financial information and status to leadership. Ensures program solution(s) meets quality and reliability requirements and that the launch approach meets or exceeds adoption targets. Monitors program results/performance for significant deviations, evaluates options and makes recommendations for corrective actions, and then implements selected actions**Knowledge and Skills:*** Some education, training or experience in biology/chemistry/engineering desirable* Drug Development knowledge and/or project management experience preferred* Proven experience in cross-functional execution including medium to large-scale projects* Critical thought partner and proven ability to connect people and ideas to drive outcomes* Demonstrated ability to connect with over divisions and functions throughout Vertex* Ability to manage multiple priorities/projects at a given time, ensuring deadlines, budgets and status updates* Highly developed communication skills and the ability to synthesize data and information into meaningful insights* Very detail oriented and strong project/operation management skills* Ability to handle ambiguity**Education and Experience:*** Bachelor's degree* Typically requires 10 years of experience or the equivalent combination of education and experience**Pay Range:**$183,800 - $275,700**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. #J-18808-Ljbffr
    $183.8k-275.7k yearly 3d ago
  • Lead, Downstream Biologics Process Development

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA job

    A global biotechnology company is seeking a Director of Downstream Process Development in Boston. This role requires advanced leadership skills and expertise in biologics, overseeing the development and optimization of therapeutic biologics with responsibilities in both technical and regulatory aspects. Candidates should have extensive experience with chromatography systems and drug substance development, ensuring compliance with quality standards. Competitive salary range is $195,500 - $293,200, and this is an on-site position. #J-18808-Ljbffr
    $195.5k-293.2k yearly 3d ago
  • Senior S&OP & Supply Chain Leader (Cell & Gene)

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA job

    A global biotechnology company is seeking a Commercial Supply Chain Associate Director to lead the Sales and Operations Planning for Casgevy. This role involves working effectively with cross-functional teams, establishing key assumptions, and overseeing performance indicators. The ideal candidate will have at least 8 years of experience in supply chain management, preferably within the cell and gene therapy field. This position is eligible for a hybrid work model, offering flexibility in workplace arrangements. #J-18808-Ljbffr
    $104k-132k yearly est. 4d ago
  • Vertex Summer Intern 2026, Clinical and Quantitative Pharmacology

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA job

    Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you'll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We're passionate about innovation, inclusion, and supporting your growth-inside and outside the lab. Why Vertex? Real Projects: You'll work on assignments that make a real impact, not just busy work. Mentorship & Networking: Connect with leaders and peers who want to see you succeed through professional networks, connections, and collaborations that will shape your longer-term career. Flexible & Supportive: We offer flexible work options with Flex @ Vertex and prioritize your wellbeing. Inclusive Culture: Collaboration and inclusion are embedded in everything we do. Career Launchpad: Build skills, explore career paths, and get guidance for your future career. Ready to apply? Submit your application and let's turn possibilities into reality! Your Impact The Vertex Clinical and Quantitative Pharmacology internship program is a multi-week experiential training program for students currently working towards a Doctoral degree in pharmacology or PharmD, or a related field of study. If you are passionate, collaborative, and growth-minded, an internship at Vertex will help you gain meaningful experience in our research functional areas and serve as a launchpad for your career. Important Notice Regarding Internship and Co-op Inquiries At Vertex Pharmaceuticals, we are committed to providing a fair and structured recruitment process for all students interested in internship and co-op opportunities. To ensure consistency and equity, all student applications must go through our Early Talent Acquisition Team. Due to the high volume of interest, we are unable to respond to individual solicitation. Direct solicitation to Vertex employees- including senior leaders via email will result in removal from the recruiting process. We appreciate your enthusiasm and interest in Vertex. To be considered for internship or co-op roles, please apply directly through our official application channels. (************************************************************************** Thank you for respecting our process and helping us maintain a fair experience for all candidates. What you will be doing: The Clinical and Quantitative Pharmacology (CQP) department at Vertex leads clinical pharmacology and clinical modeling & simulation efforts across all disease areas and clinical phases of drug development. There will be two CQP summer internship positions available with the opportunity to work with experienced mentors within CQP. A Vertex CQP summer internship will provide a 12-week hands-on opportunity to experience some of the elements of CQP within drug development. Based on the project, an intern may participate in numerous activities, such as design and conduct of clinical pharmacology studies (e.g., first-in-human, drug interaction, food effect, special populations, ADME), or exploration of drug pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationships and related analyses (e.g. population PK or other advanced modeling). Activities the successful candidate may be involved in include literature research, drafting and reviewing clinical study protocols, reviewing clinical study report sections, creating analysis plans, learning to manipulate and create clinical analysis-ready datasets, build and evaluate models, execute analyses, and prepare informative outputs, graphics, and results representations. During the 12-week appointment, the summer intern will also be exposed to various aspects of the drug development process and thereby gain a view into how the CQP functions fit within broader cross-functional drug development teams that often include preclinical disciplines, clinical development, clinical operations, bioanalysis, biostatistics, and more. Not only will interns learn about their day-to-day responsibilities, but they will interact with scientists from various levels, and with organizational leaders and their teams through a series of Professional Development Workshops that are provided during the summer. Clinical and Quantitative pharmacology activities may include the following (project dependent): Research literature, published studies, and regulatory guidance Learn to work with and manipulate clinical data and data constructs Analyses of data collected from literature or clinical trial PK and/or PK/PD data in NONMEM, R and/or related software Summarize the main findings Prepare presentation(s) for various internal forums What you will need to succeed: Enrolled in a PhD or PharmD program in pharmacology, or a related field of study by Fall 2025. Communicate clearly through verbal and written communication Understanding of drug metabolism, PK, and PK/PD principles Knowledge of protein therapeutics preferred Quantitative and hands-on skills preferred: PK and/or PK/PD analyses Experience with data analysis tools such as R, Phoenix WinNonlin, NONMEM or other programming/software applications Prior industry experience preferred but not required Legal authorization to work in the United States, now and in the future. Please note that Vertex does not provide sponsorship for internships or entry level roles within this part of the organization. You must be available to work full-time, 40 hours per week from May - August 2026 Program Details: Full-time, paid internship $33.00 - 50.00 USD/hour Program Dates: May - August 2026 At Vertex, we believe that when you feel your best, you can perform at your best. That's why our US benefits and global well-being resources are designed to support you. • Free 24/7 onsite gym access and free access to group exercise classes • Subsidized commuter benefits- transit and parking • Provided meals-free breakfast daily! • Career development opportunities and events, including C Suite engagement • Social events-both intern-only and company-wide • Location-specific perks and extras! • Recognition of National Intern Day Equal Opportunities 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. Vertex is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accessibility & Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Vertex is committed to offering reasonable accommodations to qualified job applicants with disabilities. 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. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role, Vertex is unable to sponsor non-U.S. persons to apply for an export control license. This job posting is for a temporary role with a third-party agency partner that provides services to Vertex. The individual selected for this role will be offered the role as an employee of that third-party agency; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency upon offer. For any questions or concerns, please contact early_***************. Pay Range: $0 - $0 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
    $33-50 hourly Auto-Apply 40d ago
  • Finance Systems & Reporting Excellence Director

    Vertex Pharmaceuticals 4.6company rating

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    A leading biotechnology company is seeking a Director, Global Process Excellence to enhance finance systems and processes integral to scaling operations. This role requires extensive finance experience, capability in project management, and leading cross-functional improvements. The position offers a hybrid work model and competitive salary range of $180,800 - $271,100, along with generous benefits and annual bonus eligibility. #J-18808-Ljbffr
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    Vertex Pharmaceuticals 4.6company rating

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    A global biotechnology firm is seeking a Technology focused Chief of Staff to support the Chief Digital and Information Officer in leading the digital transformation and IT strategy. This key role requires strong expertise in program management, operational excellence, and technology leadership. The ideal candidate will facilitate strategic planning, oversee key initiatives, and enhance collaboration within an innovative environment. Experience in IT strategy and biotech regulatory standards is essential, along with strong interpersonal skills. #J-18808-Ljbffr
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  • Global Safety Director: Risk Strategy & Leadership

    Astrazeneca 4.6company rating

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  • Nephrology Medical Affairs Leader, Global Strategy

    Vertex Pharmaceuticals 4.6company rating

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    Vertex Pharmaceuticals (San Diego) LLC 4.6company rating

    Boston, MA job

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  • Head of Statistical Programming & Submissions

    Astrazeneca GmbH 4.6company rating

    Boston, MA job

    A leading pharmaceutical company is seeking a Director of Statistical Programming in Boston. This role involves overseeing programming activities for clinical studies, leading a team, and ensuring compliance with standards. Ideal candidates will have over 10 years of experience in the CRO or Pharmaceutical industry, advanced skills in SAS, and strong project management capabilities. This position offers the opportunity to contribute significantly to various therapeutic areas. #J-18808-Ljbffr
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    Vertex Pharmaceuticals 4.6company rating

    Boston, MA job

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