Biogen

Lead global access management service delivery, policy and automation strategy, and compliance oversight. | Bachelor's degree with 7+ years access management experience, preferably 10+ years in cybersecurity, program management, and talent development. | About This Role: As Biogen’s Associate Director, Access Management Service Delivery- Cyber Security, 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 Associate Director, Access Management Service Delivery, 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 implementing service strategies to monitoring and reporting on service performance. Long-term, the largest lever to improve service delivery is through automation into target applications. While >95% of access transactions originate through our Biogen Access Management (BAM) platform, less than 25% are fulfilled through automation. In other words, 75% of requests require manual fulfillment by independent application teams. In the near-term, this role will work with their peer in Identity to automate the onboarding, lifecycle and deprovisioning of all types of privileged accounts. This is done manually today via BAM requests and for security’s sake, deserves to be automated. A long-term objective for this role is to work with the application owners across Biogen to adopt access automation. This role manages the performance of an integrated team, ensuring that service delivery meets or exceeds stakeholder expectations. You will serve as the business process owner for access management policy, standards and processes which includes: Authorization (Permissions): Determining what an authenticated user is allowed to do. Common models include: RBAC (Role-Based): Access granted based on job functions (e.g., "HR Manager"). ABAC (Attribute-Based): Access based on dynamic factors like location, time of day, or device security posture. Administration (Lifecycle Management): Managing the full lifespan of a digital identity, from provisioning (creation) and maintenance (role changes) to deprovisioning (deletion when a user leaves). Auditing & Reporting (Accountability): Tracking and recording user activities to maintain a clear audit trail. What You’ll Do: Continuous measurement and planning Establish stakeholder credibility with thoughtful planning. Identify what processes and/or manual transactions to improve and execute – largely through standards and automation. Proven via metrics and working with stakeholders, prioritize opportunities with existing processes, service lines and technologies, build project plans, enhancements and ad hoc operational plans that are realistic and exceed the expectations of stakeholders. Plans account for business/customer needs, user experience, and sets up the performing units/teams for success by sizing the complexity and effort accurately. Execution Own and drive forward projects, enhancements, and be the responsible owner for addressing ad-hoc operational “issues” - responsible and accountable for managing Establishing realistic timelines Deliverables Resource Management Change Management Stakeholder Management Stakeholder, Risk Management and Problem Solving Working cross-functionally as the access management SME to support needs of stakeholder projects, enhancement and operational matters that arise across our global IAM ecosystem. Anticipate and work through risks and ad hoc issues that always arise with complex infrastructures This includes command and control of major incidents that arise impacting core service lines Policy and standards setting – Enforcing compliance Establish policies, procedures, and standards – keep them current through periodic review and change management. Establish appropriate KPIs and measure compliance. Support regulatory requirements (ie. SOX, GxP) and direct/indirect audits. Who You Are: You are a seasoned leader with a passion for managing complex cybersecurity initiatives. Your strategic mindset enables you to navigate ambiguity and devise innovative solutions. You thrive in dynamic environments, leveraging your strong interpersonal skills to engage with diverse stakeholders and drive impactful change. Your commitment to excellence and continuous improvement is evident in your ability to streamline processes and enhance service delivery. You are adept at fostering talent development, ensuring your team’s success and alignment with organizational goals. Required Skills: Bachelor’s Degree in a related field At least 7 years of focused Access Management experience, including: Authorization (Permissions) Administration (Lifecycle Management) Auditing & Reporting (Accountability) 10+ years of cybersecurity experience across domains is preferred Proven success in managing complex programs and projects, including: Demand Management Project Management Requirements Definition and Management Software Design Configuration Management Integration and System Testing Strong track record of achieving customer success with business stakeholders beyond IT and Cyber domains A track record of customer success with business stakeholders outside of the IT and Cyber organizations. The ability to implement lasting solutions and services to multiple stakeholder Demonstrated success in talent development and management. Preferred Skills: Experience with automation and process improvement in an IAM context, especially access management. Familiarity with regulatory compliance standards such as SOX and GxP including: Risk Management Quality Management #LI-Remote Job Level: Management Additional Information The base compensation range for this role is: $152,000.00-$220,000.00 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 Biogen. 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. Scam Advisory: Please be cautious of scam recruitment offers claiming to be from Biogen. All legitimate correspondence from a Biogen employee will come from a "@biogen.com" email account. Learn more about scams and fraudulent job postings here.

Drive strategic alignment and decision-making for R&D business portfolio, managing stakeholder engagements and tracking initiatives. | Advanced degree and 7+ years in biotech/pharma or consulting with strong communication and matrix organization experience. | About This Role: As the R&D Business Portfolio Strategy Lead, you will serve as a senior strategic advisor to the Disease Unit (DU) Leadership team, acting as an integrator and trusted partner. Your primary mission is to enhance the effectiveness of the DU Head by promoting strategic alignment and improving decision-making processes. This role will involve supporting the development of strategic plans and preparing key deliverables related to the DU's portfolio and programs. You will translate data and analytics into value-creating strategies, optimizing strategies at the asset, franchise, and portfolio levels. In this capacity, you will coordinate DU priorities, ensuring clear direction and effective engagement with senior stakeholders. Operating at the intersection of strategy, leadership, and influence, your role is crucial to enabling a cohesive, high-performing DU. What You’ll Do: Serve as a thought partner and trusted advisor to the DU Head, providing strategic insight and counsel. Act as a proxy for the DU Head in enterprise forums and leadership discussions. Prepare and execute strategic engagements with Executive Leadership and other stakeholders. Manage and track commitments made by the DU Head to ensure timely execution. Synthesize complex inputs into clear insights and executive-level briefings. Partner with senior leaders to plan leadership engagements and communications. Contribute to strategic discussions and help shape DU priorities and direction. Develop agendas for DU meetings, focusing on critical topics. Drive alignment across Development functions by clarifying priorities and ensuring consistent messaging. Develop mechanisms to track progress on high-priority DU initiatives. Partner with senior leaders to integrate DU priorities into enterprise initiatives. Lead scenario planning to anticipate risks and opportunities affecting strategy. Who You Are: You are a strategic thinker with a keen ability to translate complex data into actionable strategies. Your high emotional intelligence and sound judgment enable you to navigate ambiguity and sensitive situations effectively. You thrive in fast-paced environments and possess exceptional verbal and written communication skills. Your collaborative leadership style allows you to influence without direct authority and you excel at fostering alignment across diverse teams. You are a natural problem solver who enjoys synthesizing information to inform decision-making. Required Skills: Advanced degree in a relevant scientific discipline and/or MBA or equivalent advanced degree. Minimum 7 years' experience in biotechnology, pharmaceutical, venture capital, or management consulting. Proven ability to operate as a senior advisor in complex, matrixed organizations. Exceptional written and verbal communication skills, including experience with executive-level materials. High emotional intelligence and ability to navigate ambiguity. Strong influencing skills without direct authority. Preferred Skills: Experience in strategic planning and execution. Familiarity with cross-functional liaison and coordination. Strong background in operational management and executive engagement. Job Level: Management Additional Information The base compensation range for this role is: $190,000.00-$261,000.00 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. Scam Advisory: Please be cautious of scam recruitment offers claiming to be from Biogen. All legitimate correspondence from a Biogen employee will come from a "@biogen.com" email account. Learn more about scams and fraudulent job postings here.

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.