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AstraZeneca jobs in Waltham, MA - 806 jobs

  • Director, Patient Services, Quality & Compliance

    Astrazeneca 4.6company rating

    Astrazeneca job in Boston, MA

    Introduction to role Are you ready to lead and innovate? As the Director of Patient Services Quality and Compliance, you'll play a pivotal role in ensuring the excellence of our Patient Support Programs for those on Alexion therapies. This is a new and critical position within our team, where you'll set strategic directions, collaborate with stakeholders, and implement ground breaking practices to meet regulatory and business requirements. Your leadership will drive the Patient Services Support Programs and Data Governance committee, leveraging the latest tools and technologies for efficiency. Are you prepared to make a difference? Accountabilities Responsible for ensuring that the PS quality processes and procedures meet regulatory requirements Lead Quality initiatives to ensure data integrity; periodic monitoring and oversight Assess and advise on the patient data governance activities & initiatives from a broader enterprise perspective Guide and advise on the key Patient data governance related decisions Recommend changes to policies, standards, and processes within patient data management Manage budgeting & resourcing for patient data initiatives and reviewing escalation requests Develop and evolve the PS quality assurance program, ensuring program execution matches key Work Instructions Periodic monitoring, review and manage changes to the Work Instructions to adjust to the changing business needs Ensure PS teams remain in compliance with key pharmacovigilance requirements through ensuring all employees and contractors have received required training, that all employees/contractors are aligned with adverse event (AE) and product complaint reporting, and that all remediation efforts are carried out per Work Instructions Implement critical tools and systems by automating repeatable tasks to improve efficiencies Work with Operations teams and other internal and external stakeholders to identify risks and areas for process improvement Oversee the execution and monitoring of internal and external audits Essential Skills/Experience Bachelor's degree in the Life Sciences or other relevant field 8-10+ years of Patient Services experience primarily leading the Quality and Compliance, patient safety functions Minimum 5 years of people management experience Proven track record working successfully in a fast-paced cross-functional environment with many stakeholders that have competing interests Comfort working through uncertainty while managing multiple, competing, and frequently shifting priorities Working knowledge of legal, regulatory, and compliance rules within the biotech/pharmaceutical industry Ability to work with external vendors during the SOW, PO, and project budget accrual processes Strong fluency in English (written and spoken language) Strong knowledge of MS Office and ability to create and edit documents using Microsoft PowerPoint, Excel, and Word Ability to present to internal and external stakeholders of 2 to 100+ people Ability to travel 30%+ of time, including weekend travel Desirable Skills/Experience Experience working in patient services or HUBs in the rare disease industry supporting a patient services organization Strong passion for digital advancement and an innovative mindset Working knowledge of salesforce.com, AI technologies and other best-in-class technology solutions Annual base salary for this position ranges from $180,875.20 to $238,000.00. AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances. In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks' paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program. Why Join Us? At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives. Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We align with all applicable laws and regulations on non-discrimination in employment and recruitment, as well as work authorization and employment eligibility verification requirements. We are using AI as part of the recruitment process. This advertisement relates to a current vacancy. Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E‑Verify. #LI‑Hybrid #J-18808-Ljbffr
    $180.9k-238k yearly 4d ago
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  • Director, Safety Scientist

    Astrazeneca 4.6company rating

    Astrazeneca job in Boston, MA

    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 4d ago
  • Country Operations Lead, Clinical Trials

    Astrazeneca 4.6company rating

    Astrazeneca job in Boston, MA

    A leading biopharmaceutical company in Boston seeks an Associate Director for Country Operations Management. The role requires a minimum of 8 years of experience in Development Operations, with strong leadership skills to drive team growth. Responsibilities include managing operational trial activities and ensuring compliance with local policies. The company offers a hybrid working model and comprehensive benefits, aiming to innovate in rare diseases and elevate patient care. #J-18808-Ljbffr
    $114k-149k yearly est. 1d ago
  • Head of Data & Analytics & AI Insights

    Takeda 4.7company rating

    Boston, MA job

    A leading pharmaceutical company in Boston seeks a Lead for Data & Analytics to manage a team focused on advanced analytics and data-driven insights. The ideal candidate will have a significant background in data modeling, machine learning, and team leadership. Responsibilities include overseeing the analytics product lifecycle and ensuring strategic alignment with business goals. This role offers a competitive salary range and rich benefits, including health insurance and retirement plans. #J-18808-Ljbffr
    $76k-110k yearly est. 3d ago
  • Medical Science Liaison, Early Development/Hematology - Northeast

    Daiichi Sankyo Company, Limited 4.8company rating

    Boston, MA job

    **Join a Legacy of Innovation 125 Years and Counting!**Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Daiichi Sankyo, Inc. (DSI) is currently seeking a Medical Science Liaison (MSL) to join the Field Medical Affairs Team. The MSL develops ongoing professional relationships with national and regional healthcare opinion leaders and other healthcare professionals to provide medical and scientific support for Daiichi Sankyo, Inc. (DSI) initiatives in selected therapeutic areas. The MSL develops skills and competencies to educate healthcare professionals, DSI internal stakeholders (e.g., Medical, Marketing, and Sales), and decision makers in healthcare systems regarding therapeutic areas and related products developed and commercialized by DSI. This is a US Medical Affairs, Field based role. This territory currently covers the following states: ME, NH, VT, NY, CT, RI, MA **Responsibilities:**Builds and maintains professional relationships with healthcare professionals (HCPs) by developing the skills and with guidance, implementing the following: * Presenting disease state and Daiichi Sankyo product specific data to HCPs* Responding to unsolicited requests for medical information* Identifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) investigator-initiated research study proposals, 3) speakers for DSI Brand Speaker programs, 4) advisors for DSI scientific, clinical and marketing advisory boards* Gathering customer insights regarding DSI and competitor products to help inform medical and commercial decision-making* Enhanced professional expertise through attendance of select scientific meetings and professional conferences for the purpose of continuing education and scientific exchange with key opinion leaders* Develops positive working relationships with local and regional internal stakeholders to enhance DSI HCP relationships* Develops the ability to apply the appropriate methods to implement the FMA department strategy within his/her geography in alignment with Medical and Brand strategies* Completes administrative duties, including monthly expense reporting and field activity reporting* Represents the Medical Science Liaison function by participating in DSI meetings, functions, events**Additional duties and responsibilities are based on position level/title, and may include but are not limited to:*** Provides innovation in enhancing and developing professional relationships with national and regional healthcare opinion leaders and HCPs to provide medical and scientific support for DSI initiatives.* Ability to anticipate trends and capitalize on opportunities* Lead special projects/initiatives.* Assist in the development of team members* Represent FMA leadership at DSI meetings, functions and events**Qualifications:** Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.***Education Qualifications (from an accredited college or university):**** PharmD, MD, PhD, NP or PA in a health sciences-related field or an equivalent combination of education and experience preferred***Experience Qualifications:*****MSL/Sr. MSL*** 1 or More Years' experience, including medical & scientific affairs, clinical practice, research, academic or US-managed markets preferred* Previous experience in Oncology, clinical research and medical education preferred**Principal MSL/Associate Director MSL*** 5 or More Years' experience including medical & scientific affairs, clinical practice, research, academic or US managed markets preferred* Previous experience in Oncology, clinical research and medical education preferred***Additional Qualifications:**** Must have a valid driver's license with a driving record that meets company requirements* Ability to travel up to 60%**Compensation and seniority level/title based on experience and qualifications.** *Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.***Salary Range:**$150,800.00 - $226,200.00**Job Summary:**At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc. #J-18808-Ljbffr
    $150.8k-226.2k yearly 1d ago
  • Global Head, Design & Delivery, Pharma Digital

    Takeda 4.7company rating

    Boston, MA job

    A global biopharmaceutical company is looking for a Head of Design & Delivery in Boston to lead the digital product strategy across its Pharmaceutical Science portfolio. The role involves managing a global team and overseeing the delivery of innovative digital solutions while driving operational excellence in CMC processes. Candidates should possess extensive experience in pharmaceutical R&D technology and strong leadership skills. #J-18808-Ljbffr
    $97k-160k yearly est. 3d ago
  • Executive Director, Pharmacometrics Head

    Takeda 4.7company rating

    Boston, MA job

    Objective / Purpose: Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data and Quantitative Sciences Department (DQS) is made up of more than 700 quantitative scientists who harness the insight of data to speed the development of highly innovative treatments to patients. The scientists (from pharmacometrics, quantitative clinical pharmacology, DMPK&M, Translational biomarkers and bioanalysis (TB&B), Imaging, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real‑world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS and Quantitative Pharmacology and Translational Science (QPTS), the Pharmacometrics team is a therapeutically agnostic team driving, implementing and executing an MIDD strategy for each asset from pre‑FIH through life‑cycle management within the global project team. Position Objectives: Strategically leads and drives the implementation of model‑informed drug development strategies across the early and late phase clinical portfolio to enable robust dose/regimen recommendations, trial designs, and go‑no‑go decisions through the life‑cycle of our products in collaboration with other functions (e.g. QCP, SQS, GEO). Drives the implementation of automation and the use of AI in the discipline of pharmacometrics (E2E) to enable increased capacity, quality and timeline efficiencies. By being integrated into the AI eco‑system, you will be constantly driving the advancement of the field and enabler of data and model‑based decision making across all phases of drug development. Is a recognized expert internally and externally in the field of mechanistic modelling and more traditional pharmacometrics with demonstrated experience optimizing clinical drug development. Demonstrated expertise in applying MIDD principles to emerging data sources (RWD, natural history registries, omics data, HER data, etc.) to fully inform development programs. Explores and excels in synergistic relationships with experts and leaders in statistics, and other key data science disciplines driving and integrated approach. Provides additional portfolio support through program reviews, collaborative decision‑making, infrastructure and best practice initiatives. Experience in applying quantitative approaches to evaluation of probability of technical success, including evaluating business development opportunities. Serves as an ambassador of Pharmacometrics, Quantitative Clinical Pharmacology (QCP), QPTS and DQS to the R&D organization and the external scientific community through high‑value participation at scientific meetings and impactful publications. Accountabilities: Leads and drives a team of in‑house pharmacometricians to deliver all pharmacometrics analyses internally and externally to support the Takeda clinical portfolio and Business development activities. Maintains a network and strong relationship with external vendors to support regulatory pharmacometrics analyses. Operates at an enterprise level, defines, leads and drives cross therapeutic area and platform level pharmacometrics strategies with the aim of driving the advancement of the Takeda portfolio through various decision‑making milestones. Seeks opportunities to extend MIDD based approaches beyond drug development to decisions impacting product valuation and reimbursement. Leads and Drives the evolution of our in‑house modelling platform capabilities with a vision of increased automation, integration of emerging data sources in addition to program‑level clinical trial data, and use of AI with an end‑to‑end mindset and process, in compliance with GxP. Works with colleagues in DMPK&M to enable the transition and implementation of mechanistic modelling and thinking (PK‑PD, PBPK‑PD, QSP) into the clinical portfolio as an asset progresses through IND, with the aim of enriching our understanding and potential opportunities, populations, dosing, trial design optimization. Key driver of pharmacometrics strategies, including Model‑Informed Drug Development (MIDD) as part of the overall QDM framework integrating pharmacometrics plan in collaboration with QCP and SQS. Represents Pharmacometrics, where required in global or regional regulatory agency meetings and be responsible for the technical component of the clinical pharmacology summary documents for regulatory submissions. Maintains a high standard for good clinical practice, compliance, and ethics. Participates as a member of Business Development due diligence, and provides firm‑for‑purpose evidence‑based risk assessments to the team in a timely manner. Promotes and drives the Pharmacometrics vision and mission, identifying opportunities and creates delivery for DQS mission to make R&D business impact. Seen as a role model to members of QCP and DQS. Acts as a cross functional and collaborative leader. Demonstrates leadership in scientific societies and cross‑industry consortiums related to the pharmacometrics work streams within ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA. Education & Competencies (Technical and Behavioral): Desired education qualifications and equivalencies and desired minimum years industry experience: Pharm D. or PhD with 15+ years of working experience in a quantitative field with extensive experience in pharmacometrics, mechanistic modelling, statistics or chemical bio‑engineering with extensive management and leadership experience. MS with 18+ years' working experience in a quantitative field with extensive experience in pharmacometrics, mechanistic modelling, statistics or chemical bio‑engineering with extensive management and leadership experience. Desired technical skills: Established Subject Matter Expert in multiple areas internally or externally including leadership of one or more internal or external focus groups. Robust understanding of pharmacology and statistical principles. Recognized expert internally and externally in the area of pharmacometrics and clinical pharmacology and its criticality in all stages of drug development. Demonstrated passion for innovative applications and technologies, including AI and automation. Defines and leads a cross‑therapeutic strategy, directing and overseeing complex pharmacometrics analyses including developing innovative methodology/ in close partnership with other DQS functions and other internal and/or external partners. Drives innovative strategies and influences business‑critical decision‑making beyond QCP/Pharmacometrics responsibilities. Solid mathematical and pharmacological/mechanistic background and training. Experienced drug developer with a significant understanding of R&D cross‑functional strategy from candidate selection through life‑cycle management. Significant experience in HA interactions and submissions. Extensive experience in the implementation of MIDD strategies as part of global filings and approvals. Drives for efficiency and cost effectiveness in drug development plan by implementation of a robust pharmacometrics plan to optimize trial design, sample size, decisions, timepoints of assessment using innovative processes and methodologies or by building internal capabilities. Ability to evaluate benefit‑risk associated with project/asset/franchise and TAU decisions and effectively manage GPT expectations. The ability to establish external networks to facilitate collaborations across industry, government, and academia. Desired behavioral competencies: Provides strong scientific and strategic leadership. Experienced people manager/leader. Strong organizational skills in terms of process and resources. Good communicator on an inter‑personal basis as well as in an audience. Mobilizes high performance teams. Influences beyond QPTS and DQS. Effective communication including influencing others, negotiation skills, and able to manage conflicts in matrix cross‑functional teams. Prioritizes and delegates. Energizes the organization and prepares for the future. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub‑Type Regular Time Type Full time Job Exempt Yes. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr
    $208.2k-327.1k yearly 3d ago
  • Global Head of Data & Quantitative Science Delivery

    Takeda 4.7company rating

    Boston, MA job

    A global leader in biopharmaceuticals seeks a Head of Design & Delivery for Data & Quantitative Sciences to spearhead innovations in R&D technology. This role involves shaping a strategic product roadmap across data science, managing a global team, and ensuring compliance in product development. Candidates should possess significant experience in pharmaceutical R&D technology, with strong leadership and communication skills. A competitive compensation package is offered, including salary and benefits. #J-18808-Ljbffr
    $91k-125k yearly est. 2d ago
  • Strategic Planning & Execution Lead - US Medical Affairs

    Astrazeneca 4.6company rating

    Astrazeneca job in Boston, MA

    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 1d ago
  • Global Immunology Research Lead: Top Discovery Projects

    Takeda 4.7company rating

    Boston, MA job

    A global biopharmaceutical company in Boston seeks a Global Therapeutic Research Lead to manage critical drug discovery projects within gastroenterology and inflammation. You'll leverage extensive experience in drug discovery to lead project strategies, provide mentorship to teams, and drive innovations. Candidates must have a PhD and at least 15 years of industry experience. The role is hybrid with competitive compensation and comprehensive benefits. #J-18808-Ljbffr
    $93k-150k yearly est. 1d ago
  • Associate Vice President - Women's Health & Early Clinical Development

    Eli Lilly and Company 4.6company rating

    Boston, MA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Summary: The Associate Vice President (AVP), Women's Health & Early Clinical Development, serves as a pivotal leader responsible for establishing and advancing Lilly's Women's Health portfolio. We are looking for a dynamic and strategic leader with deep understanding of women's health physiology, pathophysiology and clinical care, and a passion for developing new medicines to advance women's health. The ideal candidate will have a track record of impactful translational and/or clinical research related to women's health, and a demonstrated ability to progress new medicines as part of a drug development team. Responsibilities of the role include directing research and clinical development programs through Phase 2, liaising with drug discovery scientists, external innovation, late phase development and commercial colleagues to evaluate and progress new therapeutic opportunities, and advancing external collaborations and strategic partnerships to drive impactful outcomes for women's health. The AVP will shape and execute strategies for both internal and external portfolio growth, and will collaborate closely with enterprise leaders to align scientific research and development with overarching company objectives. We are seeking a candidate with an MD or MD/PhD in gynecology or reproductive endocrinology, who specializes in the health of the female reproductive system and has provided comprehensive care for conditions including menstrual disorders, preeclampsia, infertility, menopause, and osteoporosis. Experience as a clinical researcher in academia or expertise in pharmaceutical drug development is essential. Position Responsibilities: Portfolio Strategy and Clinical Planning Shape Lilly's strategy in Women's Health by combining a deep understanding of current therapeutic landscape and competitive environment with evaluation of internal and external opportunities to build an industry-leading portfolio. Develop project concepts, investment strategies and clinical development plans that allow for efficient assessment of new therapeutic approaches and targets Collaborate with new product planning to develop and maintain Draft Launch Labels and Value Propositions that address key customer needs Contribute to and lead innovative drug discovery and development projects Serve as medical expert in interactions with external partners and during assessment of business development opportunities Clinical Research, Trial Execution and Support Collaborate with clinical research staff in design, conduct and reporting of clinical trials Review and approve risk profiles to ensure appropriate communication to study subjects Assist in planning and participate in study start‑up meetings and other activities to provide the appropriate training and information to investigators and site personnel. Participate in investigator identification and selection Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct consistent with Good Clinical Practices and local laws and requirements. Serve as resource to clinical operations personnel / clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study. Understand and actively address the scientific information needs of all investigators and personnel. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow‑up of adverse events Knowledge of clinical research methodology including latest developments in relevant areas of biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations and regulatory standards. Regulatory Support Activities Support / assist in the preparation of regulatory reports, including INDs, FDA annual reports, regulatory responses and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA communication and resolution of regulatory issues, including regulatory response, from a global perspective. Provide medical expertise to regulatory scientists. Participate in face‑to‑face meetings with FDA, EMEA and other regulatory bodies Participate in risk management planning along with affiliates and Global Patient Safety. Data Dissemination and Scientific Exchange Participate in data analysis and preparation of final reports and publications. Prepare or review scientific information in response to internal or external questions. Participate in and lead scientific disclosures and publications. Support and lead the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and international basis. Represent Lilly in external forums where standards, common protocols, assessment instruments, regulatory standards and clinical practice guidelines relevant to women's health are discussed Develop and maintain appropriate collaborations and relationships with relevant professional societies. Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals. Scientific / Technical Expertise and People Development Maintain and disseminate within Lilly information on latest developments in the pathophysiology, diagnosis, etiology, treatment and management of women's health. Critically read and evaluate the relevant medical literature. Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the priority areas Actively set and meet individual professional development goals Contribute to the development of others by acting as mentor and coach to co-workers Basic Qualifications: MD or MD/PhD. Must be board eligible or certified as gynecologist or reproductive endocrinologist or have completed the comparable level of post‑medical school clinical training relevant to the country of hiring. Clinical trialist with a track record of developing clinical plans and execution of studies in the pharmaceutical industry Minimum of five years experience in clinical research/drug development in academia or industry including the design and implementation of large global clinical trials. Minimum of five years experience in clinical practice with at least 2 years in Women's health. Qualified candidates must be legally authorized to be employed in the United States. Additional Skills/Preferences: Team‑player with proven ability to shape project direction and influence stakeholders Demonstrated ability to drive for results in a fast‑paced matrixed environment Innovation mindset with a passion for novel therapies Strong business acumen and strategic planning and execution skills Excellent written and verbal communication skills Physical Demands/ Travel: The physical demands of this job are consistent with light office duties. Up to 20% US/Global travel. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ******************************************************* for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. $291,000 - $453,200 Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day‑care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly #J-18808-Ljbffr
    $133k-171k yearly est. 1d ago
  • Senior MSL: Early Development & Hematology

    Daiichi Sankyo Company, Limited 4.8company rating

    Boston, MA job

    A global pharmaceutical company is seeking a Medical Science Liaison to build relationships with healthcare professionals and provide scientific support in Massachusetts. This role requires a PharmD, MD, or equivalent, along with 1+ years of relevant experience, preferably in oncology. Candidates must possess strong communication and relationship-building skills. Compensation ranges from $150,800 to $226,200, and a valid driver's license is required for travel. #J-18808-Ljbffr
    $150.8k-226.2k yearly 1d ago
  • Senior Associate Director, Statistical Programming

    Astrazeneca 4.6company rating

    Astrazeneca job in Boston, MA

    A leading pharmaceutical company is seeking an Associate Director of Statistical Programming to oversee statistical programming activities for clinical studies in Boston, MA. The ideal candidate will have extensive programming experience, strong people-management skills, and expertise in SAS and CDISC standards. Responsibilities include managing programming specifications, ensuring compliance with SOPs, and collaborating closely with teams. A BS/MS degree in a related field is preferred, along with a minimum of 7 years of experience in the CRO or pharmaceutical industry. #J-18808-Ljbffr
    $89k-116k yearly est. 3d 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. 1d ago
  • Senior Associate Director, Statistics & Quantitative Sciences

    Takeda 4.7company rating

    Boston, MA job

    A leading pharmaceutical company seeks a qualified individual to join the Statistics and Quantitative Sciences team in Boston. The role focuses on leading clinical trial projects, implementing effective delivery strategies, and collaborating across functions to enhance drug development processes. Candidates must possess advanced knowledge in clinical study design, FDA regulations, and robust statistical skills. A PhD with relevant experience is preferred, along with strong leadership and communication abilities. Competitive salary and comprehensive benefits are offered. #J-18808-Ljbffr
    $99k-148k yearly est. 3d ago
  • External Scientific Partnerships Lead - Rare Diseases (Equity Eligible)

    Astrazeneca GmbH 4.6company rating

    Astrazeneca GmbH job in Boston, MA

    A leading pharmaceutical company is seeking an Associate Director for External Scientific Partnerships to develop strategic initiatives with health professional societies. The ideal candidate should hold a PhD, PharmD, or equivalent and have 3-5 years of experience in the pharmaceutical field, particularly in rare disease. This role entails fostering key partnerships and engaging with thought leaders to advance medical strategies. Competitive compensation and benefits are offered, including an annual salary ranging from $150,202 to $225,304. #J-18808-Ljbffr
    $150.2k-225.3k yearly 5d ago
  • Director of US Medical Affairs: Strategy & Execution

    Astrazeneca GmbH 4.6company rating

    Astrazeneca GmbH job in Boston, MA

    A leading biopharmaceutical company in Boston seeks a Director of Strategic Business Planning & Execution. You will lead and mentor a high-performing team, drive key strategic programs, and ensure alignment across diverse business functions. The ideal candidate has over 10 years in the pharmaceutical industry, strong leadership skills, and the ability to influence at all organizational levels. This role offers a competitive salary range of $196,800 - $295,200, along with comprehensive benefits including health coverage and a retirement plan. #J-18808-Ljbffr
    $196.8k-295.2k yearly 1d ago
  • Pharmaceutical Sales Specialist, Advanced Specialty Care- Respiratory Biologics -Brockton, MA

    Astrazeneca 4.6company rating

    Astrazeneca job in Brockton, MA

    At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Senior Pharmaceutical Sales Specialist for the Advanced Specialty Team, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. Accountabilities • Develop and demonstrate knowledge of clinical disease states and treatment guidelines. • Effectively communicate product information to healthcare professionals. • Analyze trends and develop strategic business plans, leveraging understanding of the market landscape, dynamics, and patient access challenges. • Provide solutions to customers by creating a tailored customer experience based on account and HCP needs. • Identify opportunities for process improvement, demonstrate openness to new ideas, and seek innovative approaches to sales and customer engagement. Essential Skills/Experience • Bachelor's Degree • 3+ yrs of demonstrated Sales or Commercial experience or a combination of: pharmaceutical, healthcare, scientific, clinical, institutional, or related industry / settings within the healthcare ecosystem • Experience in account planning and/or complex reimbursement model OR internal AZ certification • A valid driver's license and safe driving record Essential Skills and Capabilities • Advanced Therapeutic Area Expertise: Experience and expertise in highly specialized therapeutic areas • Customer Engagement: Proven ability to engage with senior-level healthcare professionals, including specialists and hospital administrators. • Innovative Sales Strategies: Experience in developing and implementing innovative sales strategies in a highly specialized market. • Clinical Acumen: Exceptional ability to understand and communicate cutting-edge scientific research and clinical data. • Strategic Partnerships: Experience in establishing and nurturing strategic partnerships with healthcare institutions and research organizations. • Business Acumen: Proficiency in advanced data analysis and the use of analytics to drive sales performance. At AstraZeneca, we are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear. We shape the future by spotting scientifically-led commercial opportunities and acting now to operationalize and scale them. Driven by the solutions we bring to the healthcare ecosystem, we make an impact at every step of the patient journey, improving their experience and outcomes. Our agile and entrepreneurial team of visionaries is trusted to innovate and experiment, supported to learn fast from failures and move on. Join us in making a difference - apply today! No relocation assistance provided The annual base pay for this position ranges from $76,935.20-$204,973.20, Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 04-Dec-2025 Closing Date 30-Jan-2026 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.
    $76.9k-205k yearly Auto-Apply 40d ago
  • Clinical Supply Intern

    Astrazeneca 4.6company rating

    Astrazeneca job in Boston, MA

    We are looking for Sophomore and Junior students majoring in Biological Sciences, Business Administration, or a related field for a 10-week internship role at our Alexion: AstraZeneca Rare Disease site in Boston, MA from June 1 2026 to August 7 2026. Position Description: Clinical supply execution: Support forecasting, kit design, packaging/labeling, depot setup, inventory and temperature controls, and GxP documentation. Process improvement: Map workflows, analyze cycle times/errors, standardize templates/SOPs, and apply lean methods. Data and AI: Build dashboards and predictions from ERP/IRT data; pilot AI for demand sensing, anomaly detection, label checks, and shipment prioritization with quality oversight. Position Requirements: Sophomore and Junior students majoring in Biological Sciences, Business Administration, or a related field Candidates must have an expected graduation date after August 2026. Basic experience with Excel and PowerBI Project management skills such as adaptability, time management, and process improvement Enthusiasm for collaboration, cross-functional projects, public speaking, and presentation design. US Work Authorization is required at time of application. Ability to report onsite to the Seaport neighborhood in Boston, MA site 4-5 days per week. This role will not provide relocation assistance. Compensation range: $31-$32.50 per hour Compensation Pay Range: The annual base pay (or hourly rate of compensation) for this position is outlined above. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 08-Jan-2026 Closing Date 22-Jan-2026 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.
    $31-32.5 hourly Auto-Apply 5d ago
  • ADME Project Leadership for Genetic Medicines

    Eli Lilly and Company 4.6company rating

    Boston, MA job

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Our diverse ADME team is seeking a dedicated scientist with an interest in the discovery and clinical development of genetic medicines, including si RNAs, ASOs, mRNAs, gene editing, and gene therapy. We are committed to advancing scientific boundaries to develop transformative therapeutics that address the underlying causes of diseases across a wide range of therapeutic areas. Applicants with strong problem-solving abilities and innovative thinking are encouraged to apply to join our team at the expanding Boston campus. Lilly's agile ADME team collaborates closely with biologists, chemists, engineers, and various other R&D functions to deliver novel genetic medicines to patients. Team members support each other through shared learning and collective responsibility for all stages of the discovery and development process for next-generation genetic therapies. We strive to foster professional growth while advancing science to provide safe and effective new treatments to patients. Prospective candidates who are motivated, collaborative scientists interested in spearheading innovation in genetic medicine therapies are invited to connect with us and contribute to improving patient outcomes globally. A high-quality candidate will demonstrate the following: High learning agility and a keen ability to articulate and efficiently test ADME and DMPK hypotheses for complex novel molecules Strong working knowledge in fundamental pharmaceutics, pharmacokinetics/pharmacodynamics, and ADME principles - especially as they relate to novel genetic medicine therapeutic modalities Understanding of pharmaceutical regulatory guidance and expectations Agile interrogation of diverse data (e.g., in silico, in vitro, in vivo) to interpret complex data sets and to derive mechanistic understanding of drug action and ADME/DMPK characteristics Lilly seeks a skilled ADME / DMPK scientist who will: Lead and innovate in a multidisciplinary team environment with primary responsibility for ADME studies to support preclinical and clinical development of the Lilly genetic medicines portfolio Design, implement, and interpret hypothesis-driven studies to inform key ADME, PK/PD, and toxicokinetic (TK) questions Integrate ADME, PK and PK/PD endpoints with discovery chemistry and biology data to guide preclinical drug design, optimization, and delivery strategies. Engage, innovate, and collaborate with cross-functional colleagues and interdisciplinary teams Lead the preparation of ADME portions of regulatory communications and documents to support clinical development, new drug applications, and line extensions and interact with global regulatory authorities Mentor and support junior scientists and build relationships through coaching and mentorship with fellow scientists at all levels Possess excellent written and verbal technical communication and the ability to constructively lead, guide and influence teams Basic Requirements: Ph.D. in Biochemistry/Biology/Pharmacokinetics/Bioengineering/Pharmacology or a related scientific field Greater than five years of experience as a scientist in a pharmaceutical and/or biotechnology company in a role related to ADME or PK/PD Additional Skills/Preferences: Knowledge of DMPK and/or bioanalytical considerations for gene editing therapeutics Experience with PK/PD modeling and simulation Experience with targeted delivery and biodistribution of oligonucleotides and/or gene therapies Understanding of and experience with PCR, immunoassay, and/or LC/MS bioanalytical methodology Additional Information: This is a full-time position located in Boston, MA. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $184,500 - $321,200 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $184.5k-321.2k yearly Auto-Apply 60d+ ago

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