17 director 2 jobs found

Merck Job Description Directors in Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications. Directors perform job duties independently with minimal supervision, lead QP2 efforts on drug development programs, and author strategic documents. Directors are expected to have or be developing expertise in several areas, including: Serving as an expert representative for QP2 on teams developing infectious disease or vaccine assets Framing critical drug development questions for optimizing model-based development Developing and executing translational PK/PD models, population pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative...

Biogen About this role The Field Director, Medical Science Liaisons is a leadership role within US Medical Affairs and a strategic partner across Biogen. This role provides leadership, strategic direction, and operational excellence to a regional team of Medical Science Liaisons (MSLs), ensuring the effective translation and execution of medical strategy in support of meaningful patient outcomes. Biogen's priority is to continue to foster and enable a diverse and inclusive workforce - representing age, gender, sexual identity, race, ethnicity, Veterans, and people with disabilities - that reflects the communities where we operate and the patients who we serve. What You'll Do Strategic Planning & Execution Collaborate with Global Medical Directors, US and global brand teams, clinical partners, and crossfunctional stakeholders to develop and implement regional field medical strategies, translating enterprise and brand objectives into clear, actionable plans...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: The Senior Director, Clinical Pharmacology will lead Nuvalent's clinical pharmacology strategy across all development programs, including latestage registrational efforts and emerging earlyphase assets. This leader will guide dose optimization, exposure-response modeling, regulatory strategy, and clinical pharmacology components of NDA submissions. Responsibilities: Serve as the clinical pharmacology lead and develop and execute strategies to support Phase 1, registrational, and postmarketing studies, including designing and leading clinical pharmacology studies. Drive the...

Biogen About this role The Field Director, Medical Science Liaisons is a leadership role within US Medical Affairs and a strategic partner across Biogen. This role provides leadership, strategic direction, and operational excellence to a regional team of Medical Science Liaisons (MSLs), ensuring the effective translation and execution of medical strategy in support of meaningful patient outcomes. Biogen's priority is to continue to foster and enable a diverse and inclusive workforce - representing age, gender, sexual identity, race, ethnicity, Veterans, and people with disabilities - that reflects the communities where we operate and the patients who we serve. What You'll Do Strategic Planning & Execution Collaborate with Global Medical Directors, US and global brand teams, clinical partners, and crossfunctional stakeholders to develop and implement regional field medical strategies, translating enterprise and brand objectives into clear, actionable plans...

Biogen This position is hybrid to our Cambridge MA location and requires frequent on-site presence About This Role: As the Associate Director, US Forecasting, you will be a vital member of the Decision Sciences - Forecasting Center of Excellence team, tasked with developing and maintaining precise forecast models for Biogen North America's franchises. Your expertise will drive accurate predictions using both primary and secondary data assets, offering valuable insights for strategic planning and resource allocation across multiple indications. This role involves cross-functional collaboration to gather inputs, socialize outputs, and execute sensitivity and ad hoc analyses. You will empower the business to build objective forecasts and scenarios that enable data-driven decisions, maximizing shareholder value. Reporting to the Senior Director, Forecasting COE, this position offers a blend of analytical, strategic, and operational work, allowing you to engage with stakeholders...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Corporate Strategy, the Senior Manager, Competitive Intelligence (CI), will support CI activities across Nuvalent's portfolio. CI is a key function within Nuvalent, and this role is a great opportunity to have broad visibility across the organization. The key focus for this role is driver mutated solid tumors, particularly ALK+, ROS1+, and HER2m NSCLC. The role also includes monitoring of the strategies, programs, and capabilities of competitors in research, development, and promotional areas, as well as overall industry trends. Within this role,...

Biogen About This Role As the Executive Medical Director for Early Clinical Development in Immunology, you will provide scientific and strategic leadership while overseeing Early Development asset-specific programs within the Multiple Sclerosis and Immunology Development Unit (MSIDU). You will manage 2-5 programs, focusing on key goals such as First-in-Human, First-in-Patient, and Proof of Biology, with potential to evolve into pivotal global regulatory filings. This role reports to the Head of the MSIDU and involves managing a team of junior clinical development colleagues. Your work will be vital in maximizing the efficiency and effectiveness of our R&D organization, positioning Biogen as a leader in the field of immunology. By collaborating with research, biomarkers, and external innovation functions, your contributions will be integral to the successful transition from research to development. What You'll Do Provide accountability and primary oversight of...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. Title: Director, Health Economics & Outcomes Research (HEOR) The Company: With deep expertise in chemistry, Nuvalent is creating selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Senior Director, HEOR, the Director of Health Economics & Outcomes Research will lead U.S. and Global HEOR strategy for Nuvalent's portfolio, shaping value...

Merck Job Description The Cyber Value & Innovation Lead partners with Core Cyber leadership and the Rapid Innovation team to enable informed, valuedriven cybersecurity investment decisions. This role combines strategic thinking, financial rigor, and innovation execution to evaluate emerging cybersecurity capabilities through proofs of concept (POCs), research, and analysis. The role is critical in translating complex cyber and technology initiatives into clear business value while ensuring adherence to financial guardrails and enterprise priorities. Key Responsibilities Innovation Execution & Proofs of Concept Prioritize, lead, and support proofs of concept (POCs) with the Rapid Innovation team to validate emerging cybersecurity capabilities and document results. Strategic Research & Analysis Research cybersecurity trends, threats, and innovation opportunities to shape the POC and investment pipeline. Communicate findings through concise...

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...

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...

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...

Biogen This position follows a traditional 2-2-3 format from 6a-6P ( Red Day Shift) About This Role: The Manufacturing Lead performs and documents daily manufacturing operations in a cGMP environment including operation of process equipment, execution of validation protocols, revising cGMP documents, ensuring compliance to cGMP, as well as maintaining equipment and facilities. This position works closely with shift Supervisor to coordinate critical activities collaboratively and utilizes resources efficiently. This is a key preparatory role for the Manufacturing Supervisor position. The Manufacturing Lead responsibilities include but are not limited to: Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system. Coordinates and/or leads process steps as required, serving as a process step(s) expert. In coordination with Supervisor, schedules tasks for a given shift and...

Biogen About This Role This position is on a 12-hour rotation, Night shift on a 2, 2, 3 schedule This position is responsible for the supervision of manufacturing of clinical and commercial products under GMP conditions on our Large Scale Manufacturing Purification Team . The incumbent will supervise Manufacturing Associates on a Night shift; schedules shift tasks; ensures GMP compliance and safety; drafts and reviews manufacturing documents; troubleshoots; and coordinates with other departments. What You'll Do Supervises Manufacturing Associates - observing/instructing, coaching, leading and developing staff. Identifies technical/non-technical development gaps and implements applicable plans/objectives. Performs manufacturing activities per cGMPs, ensuring that reports are fully trained on a given activity prior to performing the activity. Schedules and directs daily manufacturing activities, timely communicating scheduling changes/issues to staff and...

Biogen *Our factories run 24/7 operations. Our manufacturing teamswork 12-hour shifts ( Days 6a to 6p) on a2-2-3 calendarrotation About This Role Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations - each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; Downstream (Purification), MAs perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). Downstream / Purification: Column Chromatography Viral Filtration Ultra-Filtration Bulk Dispensing of the drug substance What You'll Do Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating...

Biogen **Our factories run 24/7 operations. Our manufacturing teamswork 12-hour shifts ( Days 6a to 6p) on a2-2-3 calendarrotation About This Role Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations - each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; Downstream (Purification), MAs perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP). U Downstream / Purification: Column Chromatography Viral Filtration Ultra-Filtration Bulk Dispensing of the drug substance What You'll Do Execute daily manufacturing activities, to include operating process equipment and executing validation protocols according to cGMP Standard Operating...

Biogen About this role The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs.You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. You will represent the Statistical Programming perspective to the study team and is...