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Tetraphase Pharmaceuticals jobs - 1,649 jobs

  • Sr Director, Accounting & Finance

    Tetraphase Pharmaceuticals 4.6company rating

    Tetraphase Pharmaceuticals job in Waltham, MA

    Nortiva Bio, Inc., a subsidiary of Innoviva, Inc., is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. The company's proprietary LYNX drug delivery platform represents a major advancement in oral drug delivery, enabling the creation of medicines designed to last a week or longer in a single oral dose. Our near-term focus is on advancing clinical programs in therapeutic areas where weekly or monthly doses would improve adherence and health outcomes. Summary of Position: The Senior Director of Financial Planning and Analysis (FP&A) is responsible for leading the financial strategy and analytics for Nortiva Bio, Inc. In this high-visibility, hands-on role, this individual will serve as a strategic thought partner to the executive team, shaping our financial roadmap, driving operational financial excellence, and delivering clear, data-driven insights to drive informed decisions across the organization. The Senior Director will be critical in driving financial planning, budgeting, forecasting, and analysis to support our corporate goals and objectives. Responsibilities: * Lead the FP&A function, providing strategic financial insights that drive decision-making across programs and overall business operations. * Drive all FP&A activities including budgeting/forecasting, long-range planning, scenario modeling and financial analysis for strategic initiatives * Conduct timely analysis of monthly budget-to-actuals including variance analyses, generation and reporting of results * Serve as a strategic partner to executives and cross-functional leaders, translating complex financial data into clear, actionable insights that inform high-impact decisions * Deliver dashboards, reports, and presentations that clearly communicate the story behind the numbers and support decision-making. * Prepare detailed reports and presentations for senior management and the board. * Identify financial risks and opportunities and develop strategies to mitigate risks while supporting business growth * Partner with Legal to manage the purchasing process. * Support ad-hoc strategic initiatives as capabilities are demonstrated and opportunities arise; potential initiatives include but are not limited to: business development analyses, partner support, portfolio prioritization, and financing strategies * Continuously improve of FP&A processes, with the goal of improving efficiency while maintaining flexibility to adapt to future business needs Experience & Education: * Bachelor's degree in Finance, Accounting, Business Administration, or related field; MBA or relevant advanced degree preferred. * 10 plus years of experience in financial planning and analysis, with significant experience in the biotechnology or pharmaceutical industry Skills and Abilities: * Proven track record of strategic financial leadership and a deep understanding of clinical-stage operations, R&D budgeting and resource allocation * Experience supporting R&D functions and/or programs in a cross-functional environment * Proficiency with Excel in order to conduct complex analysis that will support key decisions * Knowledge of fundamental accounting principles * Strong analytical and financial modeling skills, with the ability to translate complex data into actionable business insights. * Excellent communication and presentation skills, with a demonstrated ability to influence stakeholders and and convey financial information clearly across all levels of the organization * Proficiency in financial planning tools and ERP systems; experience with business intelligence software is a plus. The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Nortiva Bio, Inc. is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Please Note: Innoviva Specialty Therapeutics does not accept unsolicited resumes or candidate submissions from staffing agencies or recruiters. Any such submissions will be considered property of Innoviva Specialty Therapeutics, and we will not be obligated to pay any fees associated with them unless a prior written agreement is in place.
    $90k-134k yearly est. 44d ago
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  • Facilities Engineer

    Tetraphase Pharmaceuticals 4.6company rating

    Tetraphase Pharmaceuticals job in Lexington, MA

    Nortiva Bio, Inc., a subsidiary of Innoviva, Inc., is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. The company's proprietary LYNX drug delivery platform represents a major advancement in oral drug delivery, enabling the creation of medicines designed to last a week or longer in a single oral dose. Our near-term focus is on advancing clinical programs in therapeutic areas where weekly or monthly doses would improve adherence and health outcomes. Summary of Position: Nortiva Bio, Inc. is seeking an experienced Test Engineer to drive characterization of novel long-acting oral drug products. Nortiva's ultra-long-acting oral drug delivery platform uniquely combines elements of controlled drug delivery, traditional and non-traditional formulation components and processes, and dynamic structural features required for gastric residence. In this role, you will be responsible for developing and executing laboratory methods to assess physical properties of Nortiva's long-acting oral products, ensuring phase-appropriate methods and specifications are in place to assess Critical Quality Attributes (CQAs) for clinical trial material. The ideal candidate brings experience in mechanical characterization of polymeric materials in biological environments as well as experience in mechanical test development, validation, and verification for medical devices. Strong skills in innovation, attention to detail, clear communication/documentation, and team collaboration are essential. This role is primarily onsite in Lexington, MA. Responsibilities: * Drive strategic development, validation, and execution of novel in vitro/mechanical test methods to predict in vivo performance for the drug delivery platform technology * Develop phase-appropriate methods and specifications for critical physical attributes of the product, validate methods, support batch release and stability * Ensure execution of all development and routine testing, analyze results, and correlate to in vivo data * Lead/support mechanical design of test method fixturing and equipment * Work collaboratively with formulation, engineering, and project management functions to meet timelines and prioritize efforts * Clearly align and communicate key outputs/learnings from test method development efforts and ensure knowledge is shared cross-functionally * Author and/or review CMC sections of regulatory documents and submissions Experience & Education: * BS Degree in Mechanical Engineering, Chemical Engineering, Bioengineering, Materials Science, or related field is required; an advanced degree (MS, PhD, PharmD) is preferred * 3+ years of experience in mechanical test method development and validation for drug delivery technologies, combination products, or medical implants * Experience with testing plastic materials that are implanted or ingested preferred * Knowledgeable of the fundamentals of polymer chemistry, material properties, and composites Skills and Abilities: * Strong data analysis skills, including design of experiments and/or statistical modeling using software such as JMP * Familiar with mechanical design of fixturing and/or tooling, computer-aided design (CAD) software programs, and 3D printing technology * Excellent analytical and problem-solving skills; fast learner with the ability to adapt to changing priorities and thrive in a fast-paced environment * Eagerness to support teammates across functions, providing hands-on support for testing and manufacturing as needed The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Nortiva Bio, Inc. is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
    $84k-108k yearly est. 28d ago
  • Remote MSL: Osteoporosis Expert (Senior)

    Upsher-Smith 4.7company rating

    Remote or Waltham, MA job

    A biopharmaceutical company is seeking a Medical Science Liaison/Senior Medical Science Liaison based in the Dallas/Fort Worth metro area. This role involves developing relationships with healthcare leaders to improve health outcomes in osteoporosis. The ideal candidate will have a doctorate and experience in the sector. Key responsibilities include scientific communication, collaboration with stakeholders, and supporting research initiatives. The compensation range is competitive, reflecting experience and qualifications. This position requires up to 70% travel and offers a flexible remote work environment. #J-18808-Ljbffr
    $93k-147k yearly est. 1d ago
  • Medical Science Liaison - East (PA and Upstate New York) - Pain

    Upsher-Smith 4.7company rating

    Waltham, MA job

    The Medical Science Liaison (MSL) will play a crucial role in supporting the pain program, with a specific focus on near-term launch. The MSL serves as a scientific liaison to the medical/academic community and is responsible for establishing and maintaining relationships with (Allied) Health Care Providers/Professionals (HCPs) and other key stakeholders involved in healthcare decision making to ensure the appropriate dissemination of clinical, scientific, and health economic data with respect to pain and Vertex's compounds in a timely, ethical, and stakeholder-focused manner. The MSL will contribute to shaping the medical plan by providing external stakeholders' insights and contributing to the designing and execution of the Medical Affairs strategy and plan. The 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 & Responsibilities Develops and fosters effective and trusting relationships with Thought Leaders and identifies and engages other appropriate (allied) HCPs and other stakeholders involved in clinical practice decision making with regards to managing conditions associated with pain, resulting in scientific engagement with a large network of stakeholders involved in affecting care of patients experiencing pain. Utilizes expertise in pain to understand the inter-relationships both within and between academic centers and integrated delivery networks and enhances 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 clinical, scientific, and health economic 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. Demonstrates in-depth conceptual and practical knowledge of the role of pharmacists, P&T committees, payers, and Integrated Delivery Networks in the region and possesses an understanding of the impact of payers on patient care delivery. Assists clinical development/clinical operations by fully understanding IB content and presenting IB material at SIV meetings, providing nominations for trial sites as requested, and 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 as the "MSL congress lead" through organizing and scheduling abstract/session coverage and preparing and delivering the conference debrief. May serve as a mentor or trainer for colleagues with less experience, 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/Skills Previous training in or experience with medical conditions associated with pain 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 create innovative solutions to identified issues 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 the healthcare regulatory environment Proficient in using Microsoft Office programs and working in a matrix environment Apply proficient knowledge of relevant disease and disease management protocols, healthcare environment, and competitors to articulate the medical and scientific value of our products Demonstrated working understanding around compliance and regulatory frameworks governing 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 & Local Language (oral and written) Requirements Minimum requirement for advanced biomedical or life sciences degree (ex. Masters, NP, PA) or Terminal science degree desirable (PhD, PharmD, MD) Requires a minimum of 3 years of experience as a MSL, or in other comparable roles in the pharma/biotech industry Previous training or experience in designated therapeutic area is helpful *Travel up to 60%* *The successful candidate must live within the identified territory near an airport and be willing to travel routinely based on business needs.* Pay Range $150,300 - $225,500 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. 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
    $150.3k-225.5k yearly 4d ago
  • Cardio & Renal Biostatistics Director - Strategic R&D Leadership

    CSL Plasma Inc. 4.6company rating

    Waltham, MA job

    A leading biopharmaceutical company in Massachusetts seeks a Senior Director of Biostatistics to oversee statistical contributions for clinical development in Cardio and Renal therapeutic areas. This role involves leading a team of statisticians, providing statistical thought leadership, and ensuring excellence in clinical trial design and regulatory submissions. Candidates should have a PhD in statistics and over 10 years of industry experience. This position offers the chance to contribute to innovative therapies and make a meaningful difference in patients' lives. #J-18808-Ljbffr
    $44k-97k yearly est. 3d ago
  • Finance Tech Leader: Tax, Treasury & Accounting (Hybrid)

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    A leading biotechnology company in Boston is seeking an experienced Senior Director, Finance Technology to drive innovation across Financial Systems, focusing on Tax, Treasury, and Accounting. The ideal candidate will have over 12 years of experience in financial systems leadership, strong stakeholder engagement skills, and a passion for technology. This role offers competitive compensation and hybrid work options. #J-18808-Ljbffr
    $71k-96k yearly est. 4d ago
  • Director, R&D Quality Governance & Risk

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA job

    A global biotechnology company is seeking a Director of R&D Quality Governance & Risk Management to lead and enhance the governance framework supporting risk-based decisions. This strategic role requires 10+ years of R&D QA experience, strong leadership presence, and operational agility. Candidates should possess exceptional collaboration skills and mentorship capabilities. The role offers flexibility in a hybrid work environment with competitive compensation and comprehensive benefits. #J-18808-Ljbffr
    $141k-181k yearly est. 5d ago
  • Global Safety Director: Risk Strategy & Leadership

    Astrazeneca GmbH 4.6company rating

    Boston, MA job

    A leading pharmaceutical company is seeking a Director, Safety Scientist in Boston. This role involves leading risk management for key projects, mentoring safety scientists, and ensuring compliance with regulatory standards. The ideal candidate has advanced degrees and extensive experience in drug safety. This position offers a competitive salary range of $175,000 to $263,000 along with various benefits and incentives. #J-18808-Ljbffr
    $175k-263k yearly 1d ago
  • Senior Embedded Firmware Engineer - BLE, GATT, RTOS (Boston)

    Nia Therapeutics 3.3company rating

    Boston, MA job

    A pioneering neuroscience company based in Boston, MA is seeking a firmware developer to create embedded solutions for advanced brain stimulation devices. The ideal candidate will have a strong background in C programming, experience with BLE protocols, and a passion for building innovative healthcare technologies. The role offers comprehensive benefits, including health insurance and stock options. #J-18808-Ljbffr
    $109k-140k yearly est. 1d ago
  • Global Brand Leader, Oral PCSK9i

    Astrazeneca 4.6company rating

    Boston, MA job

    A top pharmaceutical company in Boston is seeking a Global Commercial Head for the oral PCSK9i asset. This pivotal role involves developing and executing a comprehensive global marketing strategy, leading brand planning, and leveraging customer insights to inform product strategies. The ideal candidate will have over 15 years of experience in pharmaceutical commercialization, with a strong background in cardiovascular, renal, and metabolic functions. Exceptional leadership and collaboration skills, alongside a BA/BS in related fields, are essential for this role. #J-18808-Ljbffr
    $109k-142k yearly est. 5d ago
  • Global Head of mRNA Research & Biomarkers

    Sanofi 4.3company rating

    Waltham, MA job

    A global biopharmaceutical company is seeking a Global Head of Research and Biomarkers in Waltham, MA. This executive role involves leading R&D for mRNA and LNP, strategizing biomarker optimization, and managing teams of scientists. Ideal candidates will have a PhD and over 15 years of experience in the biotech industry, alongside skills in molecular biology and team leadership. This is an opportunity to advance next-gen scientific innovations in vaccines. #J-18808-Ljbffr
    $69k-97k yearly est. 4d ago
  • Senior O2C & Credit Control Leader - Cash Flow Champion

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA job

    A global biotechnology company is seeking a Senior Manager for their Order to Cash function to drive cash flow optimization and manage credit control. This role requires excellent stakeholder management and financial analysis skills. The successful candidate will work closely with various teams, present updates to senior leadership, and have opportunities for personal development in a hybrid-eligible environment. Experience in pharmaceutical or large organizations is preferred. #J-18808-Ljbffr
    $113k-150k yearly est. 5d ago
  • Finance Systems & Reporting Excellence Director

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA job

    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
    $180.8k-271.1k yearly 2d ago
  • Global Development FP&A Director - Clinical Budget & Strategy

    Vertex Pharmaceuticals 4.6company rating

    Boston, MA job

    A leading biotechnology company in Boston seeks a Senior Director of Global Development FP&A to spearhead financial planning and analysis for clinical trials. The ideal candidate has deep expertise in clinical trial finance, project management, and cross-functional collaboration. Responsibilities include managing complex budgets and providing strategic insights to senior leadership. This hybrid-eligible role offers a competitive salary and benefits package. #J-18808-Ljbffr
    $173k-236k yearly est. 1d ago
  • TMF Document Specialist

    Verastem 3.7company rating

    Boston, MA job

    Company Profile: At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We've successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients. The TMF Document Specialist is responsible for owning and overseeing the management and quality control of Trial Master File (TMF) documentation across multiple Phase I-IV global studies. This hands-on role involves leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to project teams. The TMF Document Specialist will play a key role in inspection readiness, process improvement, and training initiatives. The TMF Document Specialist works closely with cross-functional teams, including Clinical Operations, Quality Assurance, Regulatory Affairs, and vendors/CROs to ensure the accuracy, completeness, and timeliness of TMF documentation. TMF Document Management & Oversight Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements. Lead and perform milestone TMF reviews, ensuring that all required documents are accurately filed, complete, and accessible. Serve as a hands-on TMF expert, guiding staff and study team members on best practices in document management. Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks. Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues; support implementation of corrective actions, as needed. Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community including guiding key document attributes (i.e., classification of documents) and resolution of document queries. Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible. Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment. Project Team Support Act as a senior liaison between vendors/CROs, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle. Collaborate with internal stakeholders to gather and provide critical information needed for the execution of the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with Study Specific TMF Plan and TMF Index. Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues, in both an insourced and outsourced model. Provide oversight of vendor/CRO TMF deliverables, including quality and adherence to contractual expectations. TMF Metrics & Reporting Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data-driven insights to identify areas for improvement. Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes. Provide regular TMF/eTMF status updates during Clinical Project Team Meetings and Clinical Operations Team meetings. Inspection Readiness Ensure the TMF complies with all applicable regulatory requirements and guidelines. Prepare for and support regulatory inspections and audits related to the TMF, including preparation of documentation. Partner with Quality Assurance to build inspection readiness practices appropriate for a growing organization. Qualifications Bachelor's Degree Required. 3+ years of hands-on Veeva Vault eTMF experience required. 5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience in a start-up with global clinical trials is highly desirable. TMF Certification or TMF training optional but preferred (e.g., DIA's TMF Certificate Program. LMK TMF University) or other relevant certifications. Key Skills, Abilities, and Competencies Working knowledge of clinical research documents across Research and Development (i.e., Regulatory, Clinical Supplies, Drug Safety, Biostatistics, etc.). Experience in managing TMF documents during audits or regulatory inspections. Extensive experience in TMF management, with a deep understanding of GCP, GDP, ALCOA+ standards, and regulatory requirements. Basic understanding of study and site management and overall trial planning and execution. Basic understanding of ICH-GCP guidelines and FDA/MHRA/EMA/PMDA regulations. Familiarity with MS Word, MS Excel (strongly preferred), and MS PowerPoint. Core Competencies Ability to work independently and collaboratively, taking ownership as required, in a fast-paced, evolving matrixed team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills with the ability to manage ambiguity and shifting priorities and deadlines. Strong work ethic, organizational skills, oral and written communication skills, a ‘can do' approach, problem-solving skills, and team player skills. Ability to multi-task and manage several projects in parallel while paying attention to detail. Strong critical thinking skills and ability to contribute creative yet practical solutions to problems. The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
    $51k-87k yearly est. 15d ago
  • Mechanical Test Engineer-Drug Delivery System

    Tetraphase Pharmaceuticals 4.6company rating

    Tetraphase Pharmaceuticals job in Lexington, MA

    Nortiva Bio, Inc., a subsidiary of Innoviva, Inc., is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. The company's proprietary LYNX drug delivery platform represents a major advancement in oral drug delivery, enabling the creation of medicines designed to last a week or longer in a single oral dose. Our near-term focus is on advancing clinical programs in therapeutic areas where weekly or monthly doses would improve adherence and health outcomes. Summary of Position: Nortiva Bio, Inc. is seeking an experienced Test Engineer to drive characterization of novel long-acting oral drug products. Nortiva's ultra-long-acting oral drug delivery platform uniquely combines elements of controlled drug delivery, traditional and non-traditional formulation components and processes, and dynamic structural features required for gastric residence. In this role, you will be responsible for developing and executing laboratory methods to assess physical properties of Nortiva's long-acting oral products, ensuring phase-appropriate methods and specifications are in place to assess Critical Quality Attributes (CQAs) for clinical trial material. The ideal candidate brings experience in mechanical characterization of polymeric materials in biological environments as well as experience in mechanical test development, validation, and verification for medical devices. Strong skills in innovation, attention to detail, clear communication/documentation, and team collaboration are essential. This role is primarily onsite in Lexington, MA. Responsibilities: Drive strategic development, validation, and execution of novel in vitro/mechanical test methods to predict in vivo performance for the drug delivery platform technology * Develop phase-appropriate methods and specifications for critical physical attributes of the product, validate methods, support batch release and stability * Ensure execution of all development and routine testing, analyze results, and correlate to in vivo data * Lead/support mechanical design of test method fixturing and equipment * Work collaboratively with formulation, engineering, and project management functions to meet timelines and prioritize efforts * Clearly align and communicate key outputs/learnings from test method development efforts and ensure knowledge is shared cross-functionally * Author and/or review CMC sections of regulatory documents and submissions Experience & Education: * BS Degree in Mechanical Engineering, Chemical Engineering, Bioengineering, Materials Science, or related field is required; an advanced degree (MS, PhD, PharmD) is preferred * 3+ years of experience in mechanical test method development and validation for drug delivery technologies, combination products, or medical implants * Experience with testing plastic materials that are implanted or ingested preferred * Knowledgeable of the fundamentals of polymer chemistry, material properties, and composites Skills and Abilities: * Strong data analysis skills, including design of experiments and/or statistical modeling using software such as JMP * Familiar with mechanical design of fixturing and/or tooling, computer-aided design (CAD) software programs, and 3D printing technology * Excellent analytical and problem-solving skills; fast learner with the ability to adapt to changing priorities and thrive in a fast-paced environment * Eagerness to support teammates across functions, providing hands-on support for testing and manufacturing as needed The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Nortiva Bio, Inc. is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
    $89k-109k yearly est. 28d ago
  • Strategic Kidney Policy & Alliances Director

    Vertex Pharmaceuticals (San Diego) LLC 4.6company rating

    Boston, MA job

    A global biotechnology company is seeking a Policy & Alliance Development Director to build policy initiatives and strategic alliances focusing on kidney disease. The role involves developing reimbursement strategies and managing partnerships with patient organizations. Ideal candidates will have extensive experience in public policy, government affairs, and a Bachelor's degree. A hybrid work model is available, with competitive compensation between $204,600 and $307,000 annually. #J-18808-Ljbffr
    $204.6k-307k yearly 1d ago
  • Medical Science Liaison - Rheumatology

    Upsher-Smith 4.7company rating

    Waltham, MA job

    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to AbbVie. Ensure a strong medical and scientific presence for AbbVie in key academic centers by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to AbbVie. Ensure consistent account management together with the other members of the In-field team. Assist in the initiation, oversight and follow up of assigned clinical studies and medical projects initiated within the therapeutic area for which the MSL carries responsibility. All such activities must comply with applicable local laws, guidelines, codes of practice, AbbVie regulations. Act as the point of contact with thought leaders and support the local and global medical teams as appropriate. Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within an assigned geographic area in order to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant AbbVie medicines, to support their safe, effective and appropriate use. Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.), where requested. Facilitate medical and scientific field intelligence. Support internal teams such as sales and marketing to develop their scientific and technical expertise through the delivery of scientific updated presentations. Qualifications Medical Doctor or health-related science background (pharmacy, biotechnology, life-science, biology, bio-chemistry) is mandatory. Advanced degree (PharmD., MD, PhD) in a relevant scientific discipline is preferred. Experience in developing and maintaining expert knowledge for the assigned therapeutic area, and in medical research in general. Solid knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company. Demonstrated expertise in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research. Ability to comprehensively learn about new subject areas and environments. Excellent written and spoken communication and presentation skills, with a demonstrated ability to develop and maintain strong collaborative relationships with thought leaders, physicians, and other healthcare decision makers. Good understanding of written and oral English. High customer orientation. Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity. Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: ************************************************************* #J-18808-Ljbffr
    $98k-174k yearly est. 1d ago
  • Global Safety Director: Risk Strategy & Leadership

    Astrazeneca 4.6company rating

    Boston, MA job

    A global biopharmaceutical company based in Boston seeks a Director, Safety Scientist to lead risk management and mentor junior scientists. Responsibilities include managing safety evaluations, preparing regulatory documents, and representing global safety at inspections. Ideal candidates have advanced degrees and over 7 years in drug safety, with experience in risk management regulations. Offering competitive salary, incentives, and diverse benefits. #J-18808-Ljbffr
    $133k-180k yearly est. 4d ago
  • Global Marketing Director - Pove

    Vertex Pharmaceuticals 4.6company rating

    Remote or Boston, MA job

    **Job Description****General Summary:**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 #J-18808-Ljbffr
    $195.2k-292.8k yearly 4d ago

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Tetraphase Pharmaceuticals may also be known as or be related to TETRAPHASE PHARMACEUTICALS INC, Tetraphase Pharmaceuticals, Tetraphase Pharmaceuticals Inc and Tetraphase Pharmaceuticals, Inc.