90 program management jobs found

Biogen The Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). The COPL is a key contributor as the lead program level QSDO representative to the Development Asset Team (DAT) and as called upon to the Product Development and Commercialization team (PDC). This individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility & financials) perspective to meaningfully contribute and make recommendations to Integrated Asset Plans (IAP), clinical development plans, and other key plans and initiatives necessary to advance Biogen clinical programs. The COPL is accountable for the strategy, planning, oversight and delivery of program level...

Biogen The Director, Clinical Operations Program Leadership (COPL) is responsible for leading the strategy, planning and implementation of clinical development program operations in the Clinical Trial Delivery Unit of the Quantitative Science Development Operations organization (QSDO). The COPL is a key contributor as the lead program level QSDO representative to the Development Asset Team (DAT) and as called upon to the Product Development and Commercialization team (PDC). This individual is responsible for providing advanced functional and technical expertise and insights from both a strategic (decision points, risk) and operational (timeline scenarios, feasibility & financials) perspective to meaningfully contribute and make recommendations to Integrated Asset Plans (IAP), clinical development plans, and other key plans and initiatives necessary to advance Biogen clinical programs. The COPL is accountable for the strategy, planning, oversight and delivery of program level...

Biogen About This Role The Senior Director, Development Asset Lead (DAL) is responsible for leading one or more preclinical or clinical-stage assets within Biogen's development portfolio. This role provides strategic, cross-functional leadership to maximize asset value and ensure effective execution of the integrated asset plan (IAP). The DAL partners across research, development, and commercial functions to align scientific strategy, operational execution, and business considerations such as time, risk, and value. As leader of the asset team, the DAL drives development strategy, oversees progress toward key milestones, and represents the program within governance forums. This role reports to the Head of Development Asset Leadership and is responsible for guiding the most complex or late-stage assets, including programs approaching regulatory filing or major stage-gate decisions. What You'll Do Lead development and continuous refinement of the integrated asset plan to...

Biogen About This Role: As a Senior Pharmacovigilance (PV) Lead, you will provide strategic and operational PV/safety support for Biogen's West Coast Hub development programs, working closely with cross-functional colleagues. This Director level position is pivotal in overseeing global safety operations, ensuring high-quality pharmacovigilance deliverables, and offering expert guidance across the organization. You will manage internal and external PV resources, lead cross-functional safety governance, and serve as a subject matter expert for safety strategy across clinical development, regulatory filings, and post-marketing activities. This role is integral to the business structure, fostering collaboration and advancing the strategic safety objectives of the organization. What You'll Do: Manage internal PV personnel and external resources, including full oversight of all PV vendor activities to ensure operational excellence and compliance. Build (where applicable) and...

Biogen About This Role The Associate Director, Medical Strategy & Operations (S&O) Lead is a strategic operations leader within North America (NA) Medical Affairs and a core member of the Specialty Care & Evidence Generation (SC&EG) Medical Leadership Team, reporting to the Head of Medical Strategy, Operations, and Excellence (MSO&E), North America. The role drives strategy-to-execution integration, enterprise alignment, and coordination of governance processes and operating rhythm across the SC&EG and Biogen North America. The role partners closely with the SC&EG Head and Medical leadership team to help advance strategic integration across Medical leadership, Field teams, Medical Excellence, Operations, Global Medical, and Biogen North America stakeholders (including Commercial and Market Access). The role identifies opportunities and supports alignment between BNA enterprise priorities and NA Medical strategy and helps ensure clarity,...

Biogen This is a remote position that requires the candidate to be located in the United States. About this role The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to senior management....

Merck Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position supports statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for the design...

Merck Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position supports statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for the design...

Merck Job Description The selected candidate will work in the Pharmaceutical Analysis & Digital Technologies (PADT) department within the Development Sciences and Clinical Supplies (DSCS) organization and serve as a primary point of contact for externalized analytical deliverables supporting Biologic development programs at various stages of development. The scope of the role will include realization of the analytical R&D externalization strategy by building analytical capabilities and driving a culture of scientific and operational excellence at our external partners including oversight of a rapidly growing team of external analysts. The candidate will partner with cross functional Development and Commercialization Teams (DCT's) and external partners to establish timelines for drug substance and drug product deliverables and will provide oversight of method development, method transfer, as well as release and stability testing for multiple programs. The candidate...

Merck Job Description The selected candidate will work in the Pharmaceutical Analysis & Digital Technologies (PADT) department within the Development Sciences and Clinical Supplies (DSCS) organization and serve as a primary point of contact for externalized analytical deliverables supporting Biologic development programs at various stages of development. The scope of the role will include realization of the analytical R&D externalization strategy by building analytical capabilities and driving a culture of scientific and operational excellence at our external partners including oversight of a rapidly growing team of external analysts. The candidate will partner with cross functional Development and Commercialization Teams (DCT's) and external partners to establish timelines for drug substance and drug product deliverables and will provide oversight of method development, method transfer, as well as release and stability testing for multiple programs. The candidate...

Biogen About This Role Corporate Development leads the establishment of Biogen's corporate strategy and is responsible for the identification, assessment and negotiation of external opportunities to augment Biogen's pipeline, as well as integration of acquired companies and management of relationships with Biogen's partners. The Search & Evaluation Director for Neuroscience will be contributing to the search and evaluation process to proactively identify and scientifically/technically evaluate external growth opportunities for inbound partnering (e.g., collaborations, licensing, and M&A). In addition to playing an important role in expanding Biogen's pipeline, the Search and Evaluation Director will have the opportunity to contribute to identifying and defining Biogen's strategy in Neurology and Neuromuscular Diseases. What You'll Do Work closely with Corporate Strategy and R&D Leadership to clearly understand the external business strategy and search...

Biogen Biogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. About This Role: As a Senior Principal Biostatistician, you will be at the forefront of leading study design and data analysis, providing statistical expertise for our products across various therapeutic areas. Your role is crucial in clinical development, biomarker development, research, and beyond. Acting independently, you will provide statistical input in scientific discussions, participate in protocol development, and oversee analysis plans and report specifications. You'll play a key role in reviewing study setup activities, ensuring the integrity of randomization and CRFs, and leading biostatistical efforts for assigned projects. Your work involves...

Biogen About This Role Pharmacometrics analyses and insight are critical in the development of drug candidates, determination of product viability, and maximization of commercial value at Biogen. As the Associate Director, Pharmacometrics, you will provide pharmacometrics expertise for high-priority clinical development programs and support quantitative decision-making through advanced modeling and simulation. In this role, you will contribute to the pharmacometrics strategy across disease areas and serve as a key scientific resource to program teams and functional partners. You will report to the Head ofPharmacometrics and collaborate closely with cross functional teams to ensure pharmacometrics analyses are appropriately applied to program needs. What You'll Do Provide pharmacometrics expertise to activities throughout the drug development lifecycle and effectively collaborate with cross functional teams Execute advanced pharmacometrics analyses, with emphasis on...

Biogen Job Description About This Role: The Senior Manager, Global Insights will partner with the Global Insights Leads for Nephrology in delivering high-quality insights and forecasting to inform strategic and operational decisions across the nephrology portfolio. This role will focus on generating actionable insights from multiple data sources, supporting market research, competitive intelligence, and forecasting activities. The individual will collaborate closely with cross-functional teams and global/local stakeholders to ensure insights are effectively translated into business strategies. The position requires strong analytical skills, strategic thinking, and the ability to synthesize complex data into clear recommendations. What You'll Do: Analyze and interpret diverse data sources, transforming them into valuable insights to understand customer groups, market trends, and business opportunities. Utilize advanced statistical methods and predictive modeling to...

Biogen About This Role: As a Therapeutic Area Lead within Biogen's Global Clinical Supply Chain, you will play a pivotal leadership role in advancing our dynamic and growing clinical portfolio. You will lead the end-to-end clinical supply chain strategy for a therapeutic area portfolio focused on late-stage clinical development while shaping the future of how clinical supply chains operate. Beyond operational delivery, this role is central to Biogen's transformation. You will help redefine how our clinical supply chains operates by harnessing data to yield new insights, establishing modernized planning approaches, and cementing new ways of working. You will directly contribute to the accelerating product-to-patient timelines and elevate supply chain performance across cost, quality, and service. As a senior leader within Biogen's West Coast Hub, you will build and grow clinical supply chain capabilities, advance critical late-stage programs toward launch, and partner...

Merck Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities: This position supports statistical programming activities for late-stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing...

Merck Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities: This position supports statistical programming activities for late-stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing...

Biogen About This Role: As a Senior Manager in IT Commercial Data Management, you will play a vital role in enhancing our data capabilities across the organization. Working closely with Enterprise IT and Business Stakeholders, you will lead pivotal initiatives that span Snowflake cloud data engineering, data product ownership, and data quality. This position requires hands-on involvement in daily engineering activities while driving strategic data projects. You will manage data-sharing and analytics as an IT Product Owner, develop innovative data products, and implement data governance across our alliance partnership. Your efforts will directly support our US Analytical teams, offering insights into HCP preferences, engagement, and channel effectiveness, thereby adding significant value to the business. This individual should have the ability to work eastern standard hours. What You'll Do: Serve as IT Product Owner, managing data-sharing and analytics with alliance...

Biogen About This Role: As a Senior IT Business Partner for Biogen's patient engagement initiatives, you will play a crucial role supporting digital patient engagement initiatives within the Patient Services IT team. In this position, you will act as a techno-functional bridge between business stakeholders and technical teams, ensuring seamless collaboration and understanding. You bring deep expertise in patient engagement processes and how technology supports the end-to-end patient journey. You will work closely with franchise leadership, Patient Services, Patient Access, and External Growth & Innovation teams to co-develop and execute a comprehensive digital and technology roadmap. This role is pivotal in shaping the future of patient engagement at Biogen, ensuring that innovative solutions are developed and implemented to enhance patient support and care. What You'll Do: Serve as the patient engagement process expert: Build deep knowledge of how Biogen supports...

Biogen This is a hybrid position that requires in-person workdays at our facilities in Durham, North Carolina. About this role The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to...