112 team leader jobs found

Biogen This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization, timelines, resources, and budgets and ensures compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP). The senior manager approves reports, analyzes data, and...

Merck Job Description Position Overview - Basic Functions & Responsibility Essential functions include, but are not limited to: Operational shift team lead, responsible for daily emergency response, safety, and security functions. Provides site-wide fire protection, emergency medical, and hazardous materials response coordination. Conducts scheduled and random inspections of all production, business, and operational support areas for fire, life safety, and security concerns. Daily functions include responsibilities for loss prevention, security, emergency response, project support, facilities, maintenance, and other service areas. Conducts fire and security audits, surveys to test existing controls, and evaluates risks involving protection of tangible and intangible company property. Enforces company regulations concerning security of company property, plant access, traffic control, parking, and employee conduct. Primary Activities The primary...

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. Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statisticalanalysis and high-quality data to support decision making in clinical trials. Responsibilities Reporting to the Executive Director of Study Data Standards and Quality Management (SDSQM), the Director of Submission Consultation (SC) provides leadership for the successful...

Merck Job Description Position Overview - Basic Functions & Responsibility Essential functions include, but are not limited to: Operational shift team lead, responsible for daily emergency response, safety, and security functions. Provides site-wide fire protection, emergency medical, and hazardous materials response coordination. Conducts scheduled and random inspections of all production, business, and operational support areas for fire, life safety, and security concerns. Daily functions include responsibilities for loss prevention, security, emergency response, project support, facilities, maintenance, and other service areas. Conducts fire and security audits, surveys to test existing controls, and evaluates risks involving protection of tangible and intangible company property. Enforces company regulations concerning security of company property, plant access, traffic control, parking, and employee conduct. Primary Activities The primary...

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. Our Quantitative Sciences team uses big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statisticalanalysis and high-quality data to support decision making in clinical trials. Responsibilities Reporting to the Executive Director of Study Data Standards and Quality Management (SDSQM), the Director of Submission Consultation (SC) provides leadership for the successful...

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 About This Role: As Biogen's Access Management Service Delivery Manager (SDM) you are the Access Management subject matter expert and services leader for all Access Management activities at Biogen. This role is accountable for delivering value to global stakeholders - which includes access services to every application in Biogen. A peer to this role is the Service Delivery Manager of Identity. This role is a direct report of the Global Leader of Identity and Access Management and is a member of the extended leadership team within the Cybersecurity organization. As Access Management SDM, you are responsible for establishing access management policies and standards and keeping them current. You are responsible for the planning and execution of initiatives that improve access management capabilities - both central platforms or efforts supporting independent stakeholder applications. This role is responsible for the entire service delivery process, from planning and...

Biogen About This Role: As the Director of the Rare Disease Reimbursement Management (RDRM) team, you will play a crucial role in leading and supporting the efforts of our team to navigate and manage the reimbursement landscape for Spinal Muscular Atrophy (SMA), SOD-1 ALS, and Friedreich's Ataxia (FA). Your leadership will be pivotal in ensuring proactive management of reimbursement environments, working closely with Account Management, Sales, and Family Access teams to implement effective reimbursement and clinical education strategies across the U.S. This role involves the selection, onboarding, coaching for performance and development, and managing employee processes. You will also lead the delivery of clinical education and in-service support to treatment sites, becoming an expert on SMA, ALS, and FA reimbursement policies, and translating local and national payer policies into actionable strategies. Collaborating with MA&R teams, you'll identify trends, provide...

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...

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 About This Role: As the Senior Director of Device Development, you will lead the charge in selecting, developing, and managing the lifecycle of platform and innovative non-implantable drug delivery devices, focusing on prefilled syringes, autoinjectors, and on-body delivery systems and combination product development. Joining the Product Delivery Solutions team, your role is crucial in advancing technology from conception through commercialization, ensuring these solutions enhance patient experiences and clinical performance. You will shape the combination product device portfolio strategy, influencing enterprise investment decisions and positioning Biogen competitively in the subcutaneous and home-use landscape. Reporting to this role is a multidisciplinary engineering organization, which you will oversee to drive iterative design, risk reduction, and scalability through prototyping. Collaborating alongside leaders in Implantable Device Technologies and...

Biogen Head of Medical Omnichannel, Digital, & Innovative Engagement North America Medical Job Description The Head of Medical Omnichannel, Digital, & Innovation Engagement will be part of the North America Medical Leadership Team and will develop and lead the Scientific & Value Communication function within North America Medical, serving as a strategic partner within Biogen to inform medical practice across our therapeutic areas and pipeline. Reporting to the Head of North America Medical, this high-impact position will implement cutting-edge strategies that integrate traditional scientific communications with innovative digital tools, artificial intelligence, and multichannel platforms. The successful candidate will shape our scientific narrative across Biogen's therapeutic portfolio while building next-generation capabilities that amplify our scientific impact and enable measurable patient outcomes. Through a cross-functionally accepted Scientific...

Biogen About This Role As the Head of Translational Immunology, you will play a critical leadership role in driving innovation and advancing the organization's research and development initiatives. You will join a dynamic team dedicated to the discovery, development, implementation, and interpretation of translational and clinical biomarker strategies to support the Immunology portfolio. Key responsibilities include leading the design, execution, and integration of biomarker strategies from early Research through early clinical development. A central focus of this role is advancing innovative translational approaches that integrate diverse human datasets-including genomics, transcriptomics, proteomics, cellular models, and clinical data-to inform novel therapeutic targets, generate actionable hypotheses, and provide supporting evidence for programs across the Immunology pipeline. What You'll Do Strategic Leadership and Team Building Lead and mentor a...

Biogen About This Role We are seeking a dynamic and experienced Director of U.S. Market Access Marketing to lead the evolution and execution of the U.S. market access activities for our Specialty Portfolio in Multiple Sclerosis. This is a critical leadership role responsible for driving comprehensive access strategies, payer engagement, and cross-functional alignment to ensure successful, timely product growth. What You'll Do * Evolve access strategies for products in a highly competitive access landscape * Deliver impactful value propositions, messaging, and promotional materials (both branded and unbranded) tailored to key customer segments (e.g., payers, IDNs, GPOs) * Champion pull-through activities to ensure access is being optimized at the territory level * Lead pricing and contracting strategies for payers and providers, ensuring market competitiveness and optimal access * Execute strategies for buy-and-bill environments, including physician-administered...

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 Chief Legal Officer, the VP, Compliance, will serve as the company's senior compliance leader, responsible for designing, implementing, and overseeing a comprehensive and effective global healthcare compliance program aligned with applicable laws, regulations, and industry standards. The role is both strategic and hands-on: ideal for a leader who can set vision while rolling up their sleeves to build processes from the ground up. The VP, Compliance will be a trusted advisor to Nuvalent leadership and a partner across business units. Responsibilities: Partner...

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 Chief Legal Officer, the VP, Compliance, will serve as the company's senior compliance leader, responsible for designing, implementing, and overseeing a comprehensive and effective global healthcare compliance program aligned with applicable laws, regulations, and industry standards. The role is both strategic and hands-on: ideal for a leader who can set vision while rolling up their sleeves to build processes from the ground up. The VP, Compliance will be a trusted advisor to Nuvalent leadership and a partner across business units. Responsibilities: Partner...

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...

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...