Biogen

Director

• Provide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development)
• Provide functional representation on development program and study teams
• 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
• Serve as lead author and key contributor to clinical pharmacology sections of clinical and regulatory documents
• 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

Associate Scientific Director – Clinical Pharmacology

• Leads and manages high profile clinical pharmacology activities including training, CDP and study designs with R&D across drug modalities and Biogen disease areas
• Leads clinical pharmacology efforts in early and late stage (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions
• Analyzes results, interprets, and recommends action based on study results
• Ability to represent clinical pharmacology function at governance (DPAC, RDGC, TRC) and external advisory boards
• Provides extensive regulatory strategy expertise for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents
• Maintains cutting edge knowledge of best regulatory practices, Clinical Pharmacology technology and drug development precedent
• Engages in cross-functional activities providing Clinical Pharmacology input and provides a source of Clinical Pharmacology expertise and advice to other functions across the Company
• Participates in and provides Clinical Pharmacology perspective to cross-functional committees and activities
• Maintains extensive scientific awareness and presence in Clinical Pharmacology, publishes multiple manuscripts and posters, presents at Scientific Conferences and other scientific forums
• Engages with consultants and advisors in the field, as well as the scientific community at large
• Manages and/or mentors staff within the function and matrix leadership across projects
• Develops expertise in highly specialized and/or novel aspects of Clinical Pharmacology and serves as a reference source in these for his peers

Senior Director – Clinical Pharmacology, Pharmacometrics

Clinical Research

• Help lead the design, execution, and analysis of late-stage organ transplantation clinical studies, ensuring alignment with program strategy while adhering to GCP and regulatory requirements
• Develop and refine clinical development plans, study protocols, and other trial related documents.
• Provide medical and scientific oversight of clinical trials
• Implement study-specific medical monitoring plans and support medical monitoring activities across clinical trials including ongoing review of patient eligibility, safety data, and protocol adherence
• Monitor patient safety by reviewing adverse events, laboratory results, and emerging data.
• Provide real-time medical guidance to investigators during trial conduct, including assessment of complex or unexpected clinical scenarios
• Participate in and contribute to Data Monitoring Committees, adjudication committees, and safety review meetings as required
• Support case report form design and modification to ensure optimal data capture, scientific rigor, and operational feasibility
• Direct ongoing review of clinical trial data, including query resolution, to ensure completeness, accuracy, and consistency.
• Partner with Data Management and Biostatistics to develop high-quality data review plans.
• Ensure that study databases are clean, audit-ready, and meet standards for regulatory filings.
• Work with clinical operation and site investigators to proactively identify and address enrollment challenges, ensuring recruitment goals are met
• Develop, maintain and strengthen investigator and investigator site relationships at specific study sites.
• Implement strategies to support patient enrollment and retention, including improving site engagement, participant experience, and adherence to study procedures
• Provide leadership to cross-functional project teams, partnering with clinical operations, biometrics, regulatory affairs, biomarkers, clinical pharmacology, and medical writing to deliver on study objectives.
• Establish and maintain strong external collaborations with investigators, academic partners, CROs, and other clinical trial stakeholders to ensure successful study execution.
• Represent Biogen at global scientific conferences, investigator meetings, and advisory boards.
• Support preparation and presentation of clinical data to health authorities, including FDA and EMA.
• Anticipate scientific and operational challenges, proposing innovative solutions to advance program timelines and deliverables.
• Contribute to overall portfolio strategy by integrating emerging scientific insights and competitive intelligence.

Lead Clinical Scientist, Transplant

Human Resources

• Collaborate with GBS and HR teams to document and map business processes across functions.
• Act as the primary coordinator for miscellaneous project tasks.
• Regularly monitor Jira boards to track the status of project tasks and milestones.
• Provide status updates to the Innovation Lead on the HRDI team.
• Work closely with various HR and GBS teams to ensure alignment on processes and project objectives.
• Proactively identify areas for process improvement and suggest enhancements.

Co-op, Digital Innovation, Human Resources, Global Business Services

Manager

• Design and develop training content in assigned area of therapeutic expertise; goal is to increase field force skills and knowledge to positively impact field results
• Analyze, design, develop, implement, and evaluate (ADDIE) sales training programs and materials for continuing education of experienced commercial organization
• Support learning needs for ongoing business needs including product launches, national meetings, region meetings utilizing a blended learning approach with a mix of live and virtual platforms for delivery
• Facilitate learning delivery in area of assigned therapeutic expertise while also flexing to support the broad Biogen portfolio as needed
• Engage with field leadership to provide feedback on new hire developmental needs and performance
• Design and analyze assessments to identify skills and knowledge gaps for future learning opportunities
• Design and analyze learning surveys to assess impact of learning programs
• Partner with marketing team to ensure a thorough understanding of products in marketplace, strategies, and tactics; develop training to support tactical implementation of strategy
• Collaborate with Legal, Regulatory and Compliance to develop and secure approvals of learning content for commercial organization
• Partner with Sales Leadership to understand learning needs and priorities for successful customer engagements
• Manage external vendors to build high quality learning content; ensure delivery on time and within set budget
• Engage broadly within the US Sales Leadership, Commercial Learning and Field Force Trainers to ensure alignment and achievement or organization
• Apply principles of adult learning to ensure training effectiveness
• Access resources to keep up to date on industry best practices and learning strategies
• Develop workshops and learning materials to support US and Global learning needs

Senior Manager, Commercial Learning

• Support patients/families to work through the steps required to gain access to therapy (disease and product education, site of care coordination, understanding of payer policy and procedure, and other support services)
• Play the role of patient advocate in cross functional meetings with internal partners (Case Manager, Account Executive, Market Access & Reimbursement to build and maintain accurate case plans for patients (e.g., case histories, insurance, ongoing coverage needs, treatment plan changes, etc.)
• Works cross functionally to identify and support the resolution of patient access barriers including insurance coverage, reimbursement, financial limitations, site of care, procurement/distribution issues
• Works with Market Access & Reimbursement team members to ensure appropriate reimbursement, engage with payers, specialty pharmacies, and specialty distributors to ensure access
• Must be able to provide strong emotional support for individuals living with rare diseases and their loved ones/caregivers and collaborate with them in a way that allows forward progress
• Be knowledgeable of any changes in the patient access environment to proactively identify issues that may impact access and communicate information appropriately to patients/caregivers
• Complete a comprehensive assessment of the individual needs of the patient considering the patient’s family and team of healthcare providers. This assessment will include understanding the individual’s payer policies, plan designs, including Medicaid coverage if applicable, as well as the healthcare system local to the patient.
• Develop and offer solutions to the family, when necessary, that may also include communication of alternative insurance options and how families can best connect to available resources
• Educates patients, families, and caregivers on product and all Biogen Patient services
• Develop activities with the goal of achieving greater openness and understanding of rare disease
• Build your own rare disease network/relationships through local advocacy groups, rare disease related events, and attending national conferences
• Become an expert on the Rare Disease portfolio and Biogen resources to provide the highest level of patient/caregiver support with the goal of positively impacting the patient journey

Rare Disease Family Access Manager

• Oversee all aspects of the commercial data lifecycle, from ingestion and data model to data quality and architecture, ensuring data is managed effectively and securely
• Create and maintain conceptual, logical, and physical data models for data consistency and integrity
• Partner with business units to understand data requirements, identify key data assets, and provide strategic input and direction on data usage
• As an IT Product Owner for a Therapeutic Area, support Agile Safe Framework for Implementation of initiatives
• Collaborate with data engineers to optimize data pipelines, manage data models, and support the deployment of data platforms and storage solutions
• Translate business requirements into Business Ready Snowflake Views/Star Schema Models
• Manage data within the US Snowflake warehouse from systems such as Veeva CRM, Veeva Network, Veeva Align, Marketing Sources
• Architect, build and optimize ETL/ELT processes for data management within Snowflake.
• Support data governance initiatives related to commercial data privacy and compliance
• Support and Enhance Data Quality Framework needed for US Commercial Data
• Support AI and Agentic AI initiatives on Snowflake Services such as Cortex/Intelligence
• Provide training and support to stakeholders on Data Catalog usage.
• Ensure data compliance and security with HIIPA regulations

Senior Manager, Commercial Data Management

Analyst

• 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 a 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.

Principal IT Analyst – Veeva Quality

Data Scientist

• Provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials
• Manages 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
• Leads the design and development of eCRFs, ensuring adherence to Biogen standards throughout
• Coordinates the development and testing of data management system edit checks and the listings/reports/tools utilized for the data review and discrepancy management activities
• Develops Data Management Plan documents utilized to deliver accurate, timely, consistent, and quality clinical data
• Acts as the primary and accountable Data Management (DM) representative to the study management team
• Partners with key cross functional team members to develop and implement project plans for assigned studies

Principal Clinical Data Lead

People Operations

• Lead complex investigations and manage high-risk performance cases.
• Serve as an escalation point for People Relations Partners, offering strategic guidance.
• Partner with Legal and HRBPs to shape and drive enterprise-wide PR strategy.
• Recommend and implement PR programs and interventions based on case trends.
• Contribute to policy development and ensure consistent application across regions.
• Represent PR in cross-functional initiatives and enterprise risk forums.
• Lead or contribute to PR projects.
• Support complex workforce changes and organizational restructures.
• Interpret company policies, procedures, and applicable employment laws.
• Provide guidance to employees on workplace concerns.
• Ensure accurate and timely updates of case status.
• Offer proactive risk mitigation thought partnership to stakeholders.

Senior People Relations Partner

Software Engineer

• The (Senior) Study Data Tabulation Model (SDTM) Programmer will be part of the SDTM Development and Operations organization that is evolving and responsible for fulfilling all of Biogen’s SDTM needs with presence in the Unites States and Europe.
• You will lead study level SDTM programming activities and deliverables (annotated Case Report Form (aCRF), specifications, datasets, define.xml, Study Data Reviewers Guide, etc.).
• Collaborating cross-functionally within Analytics and Data Science, you will work other study leads within the Biometrics organization to ensure timely and quality SDTM deliverables for the study.
• You will represent SDTM Development and Operations (Dev & Ops) in the Biogen Portfolio Disease Unit (DU) discussions.
• You will ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities.

Senior SDTM Programmer

Project Manager

• Lead the strategy and execution of site activation activities for global clinical studies
• Develop and maintain critical path and timelines for site activation
• Oversee and negotiate timelines for Master Informed Consent Forms (ICFs), including country and site-level ICF creation
• Ensure site activation activities are inspection-ready and compliant with ICH-GCP and Biogen SOPs
• Perform or delegate quality checks on submission and site essential documents
• Ensure timely and accurate submissions to ethics committees and regulatory authorities
• Conduct proactive risk assessments and guide mitigation planning
• Analyze metrics and KPIs to monitor performance and drive improvement
• Manage cross-functional collaboration and resource allocation to support study start-up
• Lead departmental growth initiatives and champion adoption of SSU process improvement tools and templates
• Harmonize processes and provide start-up expertise to assigned studies and programs, ensuring Final Protocol to First Patient In timelines are met or exceeded

Study Start-up Project Manager

Content Writer

• Write and/or manage complex marketed and development programs at the portfolio level based on Therapeutic Area, disease state, and/or phase of development
• Provide direct supervision for Medical Writing program leads and mentor junior writers
• Respond to Medical Writing issues with internal cross-functional teams and external development partners
• Contribute to long-term growth strategy of the department and ensure SOPs are followed across projects
• Synchronize prioritization of projects and represent Medical Writing in meetings with governance committees, regulatory agencies, and external development partners
• Perform outreach within pharmaceutical/biotech industry to maintain knowledge of evolving industry standards and establish best practices
• Prepare clinical and regulatory documents and packages: protocols and amendments, CSRs, IBs, INDs/CTAs, submissions
• Lead planning, development, and delivery of documents according to ICH guidelines, company SOPs, templates, and regulatory requirements
• Support development and maintenance of SOPs and templates for document development
• Critically analyze and synthesize complex scientific information to ensure scientific accuracy and consistency of documents
• Develop and integrate messaging and medical writing strategy to ensure consistency through documents in a therapeutic area
• Collaborate with cross-functional SMEs including Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Clinical Operations
• Participate in regulatory submission planning, timelines, and document development
• Manage and/or provide oversight of in-house and/or contractor/vendor medical writers, ensuring high-quality deliverables
• Review statistical analysis plans and clinical data reports incorporated in data-related documents and provide strategic input to TFL outputs
• Lead departmental initiatives as necessary

Director, Medical Writing

• Provide clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development) Provide functional representation on development program s and study teams and identify opportunities where modeling and simulation can ad vance 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 - o n quantitative ana lysis 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 ​