Biogen

Develop and implement global field medical training programs, leveraging digital and AI technologies, while ensuring compliance and alignment with business goals. | Extensive experience in medical training, therapy area knowledge, and proficiency with digital learning tools, along with leadership skills in managing cross-functional teams. | About This Role We are seeking a dynamic and experienced Associate Director of Global Field Medical Training & Excellence to enhance the performance and capabilities of our Field Medical teams worldwide. This critical role integrates therapy area expertise, Field Medical business acumen, and advanced training methodologies to deliver impactful learning initiatives that align with Biogen’s medical goals for field-facing employees. The Associate Director will leverage in-depth knowledge of therapy areas, products, treatment landscape, and Field Medical capabilities to develop and execute effective training programs. They will collaborate with internal stakeholders, including Medical, Global Learning, Commercial Learning, Regulatory, and Compliance teams, as well as external vendors, to design, deliver, and refine high-impact learning initiatives. Additionally, the role involves overseeing the use of the Learning Management System (LMS), including curriculum development, assignment profile management, and reporting to track and monitor learning effectiveness. By evaluating learning outcomes and adapting training plans based on success measures, this role ensures continuous improvement to meet evolving business needs and equips Field Medical teams with the knowledge and skills necessary to drive Biogen’s medical mission forward while maintaining compliance and excellence in training delivery. What You’ll Do The Associate Director of Global Field Medical Training & Excellence is responsible for building and maintaining strong relationships with medical business stakeholders to understand learning needs and implement effective solutions. Key responsibilities include: Partnering with regional medical teams to assess field medical training needs and develop learning solutions. Ensuring content accuracy, alignment with strategic objectives, and compliance with Biogen policies. Leveraging Digital technologies including AI to create innovative and efficient learning solutions tailored to Field Medical capabilities. Managing content review processes to maintain quality and adherence to regulatory standards. Collaborating with Commercial and Global training counterparts to ensure cross-functional alignment and resource efficiency. Designing and implementing diverse training formats, including e-learning modules, virtual sessions, and in-person workshops. Identifying and coordinating internal and external speakers for training programs. Delivering or supporting foundational, continuing, and advanced training offerings as needed. Developing and tracking standardized training compliance metrics and generating reports to meet business demands. Overseeing project-specific budgets, managing vendors, and reporting on training activities and outcomes. Who You Are The ideal candidate for this role is a strategic and innovative training professional with deep expertise in therapy areas, field medical capabilities, and the application of AI and digital technologies to learning and development. They excel in cross-functional collaboration, possess a strong track record of designing impactful training programs, and demonstrate the ability to align learning initiatives with business objectives while maintaining compliance and operational excellence. Required Skills Advanced Degree in a biological science or related field, Pharm.D., Nurse Practitioner, MS, MSN, Ph.D or MD and 7+years of field medical related experience at a pharmaceutical company. Extensive Field Medical Expertise: Deep understanding of field medical capabilities and medical business strategies. Training Development and Delivery: Proven ability to design, implement, and evaluate impactful training programs using various modalities (e-learning, virtual, in-person). AI and Learning Technologies: Experience leveraging AI-driven tools and technologies to enhance learning outcomes and training efficiency. Cross-Functional Collaboration: Strong interpersonal skills to effectively partner with internal stakeholders (e.g., Medical, Commercial, Compliance) and external vendors. Regulatory and Compliance Knowledge: Comprehensive understanding of regulatory requirements and compliance standards in medical training. Job Level: Management Additional Information The base compensation range for this role is: $156,000.00-$215,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. We’re united by a shared purpose, proud of our work, and inspired by one another and the lives we strive to change. We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

Provide quality oversight on shop floor activities, review exceptions, ensure compliance with batch records and procedures, support audits, and assist in quality management system implementation. | Bachelor's degree in science or related field, 4+ years in biotech/pharma quality assurance, experience with parenteral or aseptic environments, knowledge of FDA/EMA regulations, and strong organizational and communication skills. | This position will work NIGHTS from 6 PM to 6 AM on a 2-2-3 rotation schedule About This Role The Senior Quality Associate I is responsible for contributing to key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) Drug Product Parenteral Facility. Specifically, this role will have primary quality oversight of the following activities: (1) Shop floor support ensuring critical steps are executed according to batch record and procedural requirements, (2) Exceptions review and approval and (3) Respond to operational needs that require QA approval. What You’ll Do Ensures Product documentation and other documents supporting batch execution are compliant and determines acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution Drives Exceptions to closure and ensures compliance with procedures and process including thorough documented root cause analysis and well justified rational supports the stated conclusions Actively monitors the applicable data dashboards and collaborates with stakeholders to improve process effectiveness and efficiency Supports Quality Management and Operations staff in the coordination of, preparation for and follow up of internal/external audits and inspections as required Assists QA Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen Support and/or assist in GxP quality systems-related training. Provide some mentorship and training within and across functions Other job duties as assigned Who You Are You are task oriented and focused on continuous improvement. You ask copious questions and excel at root/cause analysis and troubleshooting. Additionally, you have excellent communication/collaboration skills, logical thinking, and can work across all levels of the organization. Required Skills Bachelor’s degree preferably in a field of science or biotechnology, or related Minimum of 4 years of experience working in a quality assurance capacity in a biotech or pharmaceutical manufacturing environment Experience working in a parenteral filling OR aseptic environment OR experience working with isolators Experience working on the floor and reviewing and approving batch records General understanding of relevant FDA/EMA regulations and compliance Strong organizational skills and detail oriented aptitude Ability to develop innovative/creative solutions to issues of moderate complexity Excellent oral and written communication skills Job Level: Professional Additional Information The base compensation range for this role is: $79,000.00-$103,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. We’re united by a shared purpose, proud of our work, and inspired by one another and the lives we strive to change. We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

Lead clinical development strategy and execution for immunology clinical trials, oversee clinical study documentation and regulatory submissions, and provide clinical scientific expertise to internal and external stakeholders. | MD or equivalent with specialization in immunology or related fields, 3+ years clinical research experience across all clinical trial phases, expertise in clinical trial methodology, GCP, regulatory landscape, and strong leadership and collaboration skills. | About This Role As an Associate Medical Director, Clinical Development – Immunology, you will be an integral member of the Immunology Therapeutic Area within the Clinical Development Organization. In this dynamic role, you will play a critical part in shaping and advancing clinical programs, particularly in the lupus and autoimmune disease space. Reporting to the Executive Director, you will be instrumental in crafting the clinical development strategy and leading the execution of complex clinical trials. Your leadership will not only impact the direction of clinical studies but also contribute to the broader objectives of the organization. Your expertise will be pivotal in bridging research and clinical operations, ensuring that the needs of patients are at the forefront of innovation and that the treatments developed meet the highest standards of efficacy and safety. Joining our team means taking on a role where your contributions significantly affect our mission to transform patient care in the realm of Immunology. What You’ll Do • Report directly to the Executive Director, Clinical Development Immunology, overseeing the clinical development activities within Immunology. • Collaborate with the Research Unit to facilitate the progression of projects into Phase I and Proof of Concept (PoC) clinical activities. • Contribute to and review clinical study documents such as Clinical Study Protocols (CSPs), Clinical Study Reports (CSRs), Investigator's Brochures (IBs), Patient Information Sheets/Informed Consent Forms (PIS/ICFs), and Statistical Analysis Plans (SAPs), along with regulatory submissions like INDs and Briefing Books (BBs). • Monitor, analyze, and interpret safety and efficacy data from ongoing clinical trials. • Serve as a clinical science expert for clinical study teams, Contract Research Organizations (CROs), and study sites. • Engage in cross-functional clinical study team meetings, providing valuable insights and direction. • Develop and deliver impactful presentations to internal teams and external stakeholders. • Foster relationships with key external and internal stakeholders and contribute to decision-making panels. • Offer clinical scientific expertise to support business development initiatives, including due diligence processes. Who You Are You are a visionary in the world of clinical development, driven by a passion for delivering transformative treatments to patients and healthcare systems. You possess a natural curiosity that compels you to ask probing questions and the courage to drive innovation. Quality and ethical standards are your compass; you're meticulous in your work, insisting on excellence. Data is your ally, guiding your decisions and helping to explore how technology can accelerate progress in research and development. You're a team player who thrives in collaborative environments, yet you're also capable of standing on your own with strong problem-solving skills and analytical acumen. Required Skills • MD or equivalent medical degree, with a preference for specialization in rheumatology, dermatology, or immunology. • A minimum of three (3) years of clinical research experience within an academic or industry setting, encompassing phases I through IV including experience in all facets of clinical trial execution including planning, execution, reporting, and publication. • Demonstrated ability to forge scientific partnerships with key internal and external stakeholders. • Comprehensive understanding of Good Clinical Practice (GCP), clinical trial methodology, statistics, and the regulatory and clinical development landscape. • A distinguished history in the field of immunology, encompassing both clinical and basic research. • Autonomy in working environments, complemented by the ability to collaborate across functions, and exceptional skills in problem-solving, conflict resolution, and analysis. #LTD-1 Job Level: Management Additional Information The base compensation range for this role is: $202,000.00-$278,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. Benefits In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: • Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays + 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Conduct biomarker-related literature searches, process samples using mass spectrometry techniques, develop analytical methods, participate in team discussions, and support biomarker feasibility studies in neurological and immunological diseases. | Currently enrolled student in accredited program (Bachelor’s, MD, or PhD) in Biology, Chemistry, Biochemistry, Neuroscience, or related field with interest in clinical biomarkers and mass spectrometry. | About The Role This application is for a 6-month student role from January - June 2026. Resume review begins in October 2025. The Biogen Biomarkers and Systems Biology group is seeking a highly motivated PhD student to leverage mass spectrometry-based measurements to support Biogen clinical trials in neurological and immunological diseases. Measurements from human samples may inform on target engagement, pharmacodynamics and/or disease progression. Using highly sensitive tools to understand these relationships can accelerate clinical development leading to next generation treatments for patients. What You’ll Do As a co-op you will: • Conduct literature searches related to biomarkers in clinical development. • Process samples, including protein digestions, immunoprecipitations, and solid phase extraction. • Develop analytical methods, focusing on peptide fragment quantification by high-resolution mass spectrometry. • Participate actively in team discussions and presentations, contributing to the scientific communication efforts of the group. • Engage in the design and execution of novel biomarker feasibility studies. • Identify potential biomarkers in the literature to support the development of treatments for Alzheimer’s disease, Parkinson’s disease, ALS, and/or immunology-related disorders. Who You Are You are passionate about learning and applying advanced analytical technologies to the drug development process, and have an interest in the following areas: • Neuroscience/Neurology • LC-MS assay development • Mass spectrometric data analysis • Clinical Biomarkers To participate in the Biogen Internship or Co-op Program, students must meet the following eligibility criteria: • Legal authorization to work in the U.S. • At least 18 years of age prior to the scheduled start date. • Currently enrolled in an accredited community college, college, university or skills program/apprenticeship. Education Requirements • Bachelor’s degree in Biology, Chemistry, Biochemistry, Neuroscience • MD or PhD student in Neuroscience/Neurology Job Level: Internship Additional Information The base compensation range for this role is: $33.00- The actual hourly wage offered will consider the candidate’s current academic level and degree candidacy, inclusive of Associate, Bachelor’s, Master’s, JD, MD, PhD and MBA programs. It will comply with state or local minimum wage requirements specific to the job location. In addition to compensation, Biogen offers a range of benefits designed to support our educational employees, including, but not limited to:  • Company paid holidays  • Commuter benefits • Employee Resource Groups participation • 80 hours of sick time per calendar year Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Manage financial planning, forecasting, compliance, and reporting activities supporting research operations and collaborations. | Bachelor's degree in finance/accounting, 5+ years finance experience, knowledge of U.S. GAAP and SOX, strong communication and stakeholder management skills. | About This Role The Research Finance Manager will report to the Associate Director (AD) of Finance. Under the guidance and direction of the AD, the Finance Manager will manage all aspects of the financial planning & analysis activities supporting Research, including collaborations. What You'll Do • Execution of planning activities, including annual operating plan, forecasts, and long-range plan. Work with internal stakeholders to create robust functional financial plans. Work with leadership teams to suggest ways to prioritize spending within target • Strong business partnerships and become the key resource to stakeholders ensuring all finance related matters are addressed, including reviewing and approving purchase orders • Completion of monthly close accurately and timely, including creation of journal entries, account reconciliations and variance analysis commentary to be presented at the monthly close meetings • Ensure compliance with SOX requirements and accounting policy and procedures • Maintain control of key areas of balance sheet and support external audit • Monthly variance analysis to drive accountability and influence corrective action recommendations as needed • Work with external collaboration partners, interact with corporate partners or/and Alliance Management for all financial matters. This includes ensuring all milestones and financial commitments are included in each of the forecasts, providing monthly/quarterly variance explanations, and multi-year financial obligations • Provide decision support analytics, including investment analysis as needed for prioritization and decision making • Other ad-hoc requests or projects as needed Required Skills • Bachelor's Degree in Finance, Accounting or equivalent • Minimum of 5 years of working finance experience within financial planning or accounting • Knowledge and understanding of U.S. GAAP, and SOX compliance requirements • Strong financial acumen with a value creation mindset • Strong oral and written communications inclusive of presentation abilities • Demonstrated ability to influence and build strong working relationships with business partners • High sense of urgency with the ability to meet tight deadlines while maintaining flexibility to adapt to changing priorities Preferred Skills • Life sciences industry experience, particularly supporting research divisions or departments • MBA or CPA a plus • Familiarity w/Oracle, Hyperion and Business Objects preferred Job Level: Management Additional Information The base compensation range for this role is: $106,000.00-$142,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. Benefits In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: • Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays + 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Lead and manage all clinical data management activities across clinical trials ensuring data quality, compliance, and timely deliverables while coordinating with cross-functional teams and vendors. | 7-10+ years clinical data management experience with deep knowledge of EDC systems, drug development, project management skills, and ability to lead teams and vendor relationships. | About This Role The Principal/Senior Principal Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. Manage the flow of all Clinical Data throughout the clinical study lifecycle, from initial Case Report Form (CRF) development to Clinical Study Reporting (CSR). Ensure effective project planning, risk management and provision of high-quality data deliverables. Lead the design and development of eCRFs, ensuring adherence to Biogen standards throughout. Coordinate the development and testing of data management system edit checks and the listings /reports/tools utilized for the data review and discrepancy management activities. Develop Data Management Plan documents utilized to deliver accurate, timely, consistent, and quality clinical data. Acting as the primary and accountable Data Management (DM) representative to the study management team, the Principal/Senior Principal Clinical Data Lead partners with key cross functional team members to develop and implement project plans for assigned studies. Ensures all functional activities are completed by the DM team and/or vendors according to specified quality standards and timelines to support the flawless execution of a clinical trial. May have program level responsibility and where applicable, ensuring consistent delivery of DM activities across studies within a program. Support relevant asset integration activities as required. May support special initiatives both within and outside of the Clinical Data Management department. Develops study level quality/oversight plans and ensures adherence and consistent execution. Performs holistic review of the clinical trial data to assess quality, completeness, and congruency. Identifies areas for process and efficiency improvement and implements solutions on assigned projects. Utilize study metrics and data analytics to monitor study progress and to identify risks and trends within the data. Develop and implement solutions for data management issues and concerns, including proactive prevention strategies. Manages the DM components of the eTMF and creates an audit-ready working environment. As required, represent DM during audit and inspection activities. Lead the develop and execution of CAPAs where appropriate. Support and mentor Clinical Data Managers for assigned trials, fostering strong teamwork. Where a study is outsourced to FSP partner, provide oversight and ensure vendor partner delivers to agreed quality and timelines. What You'll Do • Accountable for development of CDM timelines, project management of all end to end data management deliverables in collaboration with cross functional team members and vendors on assigned studies: • Single point of contact for the execution of data management deliverables on assigned trials/programs. Interprets and applies data strategy, ensures use of global/program standards, coordinates and oversees outsourced personnel, and monitors and reports on overall study progress. • Accountable for overall consistency of DM standards across assigned trials/program and quality/integrity of the data. Ensures high utilization of standards library components (e.g. eCRFs, Edit checks) • Develops risk mitigation or action plans and oversees execution when appropriate. • Reviews performance metrics and trends for DM deliverables on assigned studies/programs and ensures most optimal execution. Reports/Escalates issues/risks to Portfolio Lead • Primary contact between DM and clinical study management teams (SMT). Liaises directly with internal customers (Biometrics functions, Clinical, Medical, Safety, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel). • Utilizes data review tools to perform holistic review of the clinical study data. Identify trends and issues across the data. Assess risk to data quality. Independently develop and implement solutions at the study level. Share lessons learned across the program/TA/department. Propose the development and/or enhancement of standards. • Contributes to the development of DM process, data collection and management, reporting, and process improvement and innovation as needed. • Manages performance and quality issues with vendors (FSP and 3rd party data providers such as labs) and escalates to DM leadership. Develops appropriate risk mitigation, as needed. • Support study-level/drug program audit and inspection readiness activities as needed • Supports special projects and initiatives; partners with Statistical Programming, Biostatistics, Vendor Management, and Quality as well as Global Development depending on type of project. Who You Are A passionate and experienced Clinical Data Manager, with excellent planning and communication skills. A highly skilled individual with in-depth knowledge of Clinical Data Management systems and strong attention to detail. A functional leader who takes accountability for the delivery of all CDM outputs. Required Skills • For Principal Clinical Data Lead: 7+ years relevant work experience with a focus on clinical data management with full accountability across study start-up, conduct, and lock. • For Senior Principal Clinical Data Lead: 10+ years relevant work experience with a focus on clinical data management with full accountability across study start-up, conduct, and lock. • Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as eCS elluminate • Deep understanding of drug development and biopharmaceutical industry required • Exceptional project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable • High attention to detail including proven ability to manage multiple, competing priorities • Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor • Deep knowledge of clinical data management outsourcing operating model to functional-service providers and full-service/global CROs • Demonstrated ability to influence without authority • Excellent written and oral communication skills Job Level: Management Additional Information The base compensation range for this role is: $113,000.00-$175,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to: • Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays + 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

The Principal IT Analyst - Veeva Quality will design, build, implement, and maintain the Veeva Vault Training Learning Management System. This role involves collaborating with cross-functional teams to deliver system upgrades and enhancements while ensuring compliance with regulatory requirements. | Candidates should have at least 5 years of IT experience, including 4 years in Veeva administration. An undergraduate degree in Computer Science or equivalent experience is required, along with expertise in Learning Management platforms and data analytics tools. | About This Role As a Principal IT Analyst - Veeva Quality, you will play a critical role in designing, building, implementing, and maintaining Veeva Vault Training Learning Management System. Biogen is undergoing a business transformation with technology as a core enabler. Veeva Vault Training is a critical component of this transformation, and you will be the ultimate driver, leveraging your expertise to ensure high-quality service delivery, optimal system performance, and seamless user experiences. Acting as the IT System Owner for Veeva Vault Training, you will collaborate closely with cross-functional teams, including business analysts, technical architects, system configurators and project managers, to deliver upgrades, enhancements, new modules, and other initiatives aligned with strategic business roadmaps. Your work will directly support Biogen’s Employee Experience and GxP compliance, ensuring that our learning systems meet regulatory requirements and user needs. This role combines technical leadership, project management, and hands-on implementation, making it integral to our commitment to excellence in learning and development. What You’ll Do Plan and implement complex enhancements and incremental updates to Veeva Vault Training application. Collaborate with cross-functional business and IT teams to understand the end-to-end business processes and functional requirements to maximize value. Manage IT System and Release Management of Veeva Vault Training application, adhering to GxP compliance, data security, and the software development lifecycle processes. Develop and facilitate strategies for system, data and application integration, ensuring that interfaces supporting business requirements are properly identified, designed, and implemented. Oversee all configurations, development, and management activities related to assigned application services. Provide oversight and mentor development teams. Work with and manage team of internal and external 3rd party technical resources performing analysis, design, configuration, development, testing, and deployment activities. Conduct in-depth research on emerging technologies, including AI, to support systems development initiatives. Provide expert guidance to IT and Business management regarding technology trends and best practices that optimize solutions. Test new applications, major/minor releases, and recommend feature enhancements for system optimization. Develop, roll out, and support business and application services to meet evolving user needs. Support M&A and Divestiture activities by extracting or importing data into target systems as needed. Who You Are You are a resourceful and solution-oriented IT professional who thrives on delivering exceptional customer experiences. You excel at troubleshooting complex issues, conducting root cause analyses, and driving continuous improvement. Your ability to adapt to varying technical expertise levels enables you to effectively communicate with both business subject matter experts and IT architects. You are passionate about leveraging technology to enhance learning experiences and ensure compliance in a regulated environment. Required Skills 5+ years of IT experience, including 4 years in Veeva administration and service delivery. An undergraduate degree in Computer Science or equivalent education and experience. Expert technical knowledge of Learning Management/Learning Experience platforms, with relevant certifications. Proven expertise in data analytics, reporting, and dashboarding tools such as advanced Microsoft Excel, PowerBI, Tableau, or other business intelligence platforms. Knowledge of industry best practices in GxP Learning and Development. Experience in user and application support. Familiarity with incident and change management processes. Understanding of SAFe Agile framework. Preferred Skills Experience in contract and SLA management. Vendor management skills. Understanding of middleware, SFTP, Single Sign-On, and enterprise architecture concepts. Knowledge of content authoring tools and document management solutions. Job Level: Management Additional Information The base compensation range for this role is: $113,000.00-$158,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. We’re united by a shared purpose, proud of our work, and inspired by one another and the lives we strive to change. We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

Provide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle. Lead execution of clinical pharmacology studies and analyses, interpreting results and recommending actions based on findings. | Candidates must have a PhD or MD/PhD in relevant fields and at least 5 years of industry experience in clinical pharmacology. Experience with quantitative analysis and regulatory guidelines is essential. | About This Role 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. As the Lead, Clinical Pharmacology, Immunology, you will serve on program and study teams, providing strategic leadership in the development and execution of clinical pharmacology plans for drug candidates. You will integrate knowledge of clinical and quantitative pharmacology to optimize and provide rationale for dosage regimens, and study designs throughout the drug development lifecycle. This position is located in South San Francisco office or could be fully Remote. The candidate must reside within the USA. What You'll Do Provide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development) Provide functional representation on development programs and study teams and identify opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy and safety Develop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical) Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies Lead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on results Conduct hands-on quantitative analysis and present the findings to multidisciplinary project teams Serve as lead author and key contributor to clinical pharmacology sections of documents Serve as the subject matter expert in interactions with Health Authorities Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes Maintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent Qualifications PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD) Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principles Experience with designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm Knowledge of and ability to apply appropriate regulatory and ICH guidelines with regard to the acquisition, analysis, and interpretation of clinical pharmacology data Hands- on experience with developing and implementing Quantitative Systems Pharmacology (QSP) models, and/or population PK, PKPD, exposure-response analyses Experience with Model Informed Drug Development (MIDD) paired meeting program is a plus Proficiency with use of PK/PD software packages such as Phoenix, R, NONMEM. Experience with Monolix and MATLAB is a plus Excellent oral and written communication skills for effective interactions in various environments including, but not limited to, multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards Additional Information The base compensation range for this role is $144,000.00-$240,000.00. Base salary is determined by a combination of factors including, but not limited to, job-related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions. Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. Job Level: Management Additional Information The base compensation range for this role is: $144,000.00-$240,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. We’re united by a shared purpose, proud of our work, and inspired by one another and the lives we strive to change. We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.