Biogen

Role Description As a Senior Clinical Monitoring Lead, you will play a pivotal role in leading the clinical monitoring function within assigned studies to ensure high-quality trial execution and regulatory compliance. You will oversee Site Managers and Clinical Trial Coordinators, ensuring effective monitoring of clinical sites, adherence to ICH-GCP and SOPs, and timely resolution of study issues. Your leadership will support operational readiness for inspections, data integrity, and consistency across all monitoring activities. In larger or complex clinical trials, you may provide operational leadership over Clinical Monitoring Leads, ensuring that all clinical monitoring functions align with the overall project goals. By bringing your expertise and dedication, you will contribute significantly to the success of our clinical trials and the broader business objectives. What You’ll Do - Lead and manage Site Managers in all aspects of site monitoring, including site selection, initiation, routine monitoring, and close-out. - Review monitoring visit reports and follow-up letters for accuracy, completeness, and compliance with protocol, SOPs, and regulatory requirements. - Ensure consistent application of risk-based and centralized monitoring strategies across studies. - Track and report on site performance, enrollment, data quality, and issue resolution. - Ensure timely and accurate documentation in the Trial Master File (TMF) and support audit and inspection readiness. - Partner with Quality Assurance to conduct root cause analyses and implement corrective and preventive actions (CAPAs). - Supervise, coach, and mentor Site Managers, conduct performance reviews, and support professional development. - Deliver training to Site Managers on protocol requirements, therapeutic area knowledge, and monitoring best practices. - Collaborate with CTDU, CTAU, and other stakeholders to align on trial execution operational strategies. - Act as a subject matter expert on monitoring execution for internal and external partners. - Manage all aspects of monitoring operations and quality for allocated studies, ensuring compliance with ICH GCP and applicable local regulations. - Contribute to the development of clinical tools and documents. Qualifications - Bachelor’s degree in life sciences, nursing, pharmacy, or related field; advanced degree preferred. - Minimum of 10 years of clinical research experience, including at least 3 years as a CRA. - Minimum of 5 years in CRA management, mentoring, or monitoring oversight. - Strong understanding of ICH-GCP, FDA/EMA regulations, and global clinical trial guidelines. - Demonstrated experience in CRA performance management and inspection readiness. - Excellent organizational, leadership, and problem-solving skills. - Strong communication skills, both written and verbal. - Willingness to travel (20–30%, as required). - Ability to build relationships across the organization and operate effectively in a hybrid or remote environment. - Proven ability to manage multiple tasks of varying complexity within tight timelines and shifting priorities. - Strong leadership skills with the ability to influence and drive performance across clinical trial teams. Preferred Skills - Advanced degree in life sciences or related field. - Experience with global clinical trial management. - Familiarity with advanced clinical monitoring tools and technologies. Benefits - 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.

• Serve as the communications advisor to the Product Development and Commercialization Leads for the Alzheimer’s Disease franchise, and as the communications lead interfacing with external partners. • Work closely with all affiliates, including North America, to reflect customer voices in the development of global integrated communications plans and provide global guidance. • Monitor and anticipate potential issues and lead the corporate affairs response, from scenario planning to potential escalation and crisis communications. • Develop narratives and messaging platforms, informed by patient and marketing insights, for the franchise and individual products that differentiate Biogen’s programs and strategy. • Draft and manage the review process for all AD communications (news releases, Q&As, social media posts, intranet content, sponsored content) in support of the narrative. • Lead oversight of the development and execution of integrated, multi-channel pre-launch and launch communications strategies and market-shaping campaigns across digital, internal, external, and traditional platforms. • Manage the news flow of anticipated announcements and proactive storytelling opportunities. • Identify and coordinate spokespeople (Biogen leaders, KMEs, patients, advocates). • Be responsible for building and maintaining relationships with additional key internal and external stakeholders – such as Biogen advocacy leads – to ensure collaboration and alignment with business objectives. • Oversee external communication agencies to ensure timely, high-quality, and brand-aligned deliverables. • Develop measurable goals to track the impact and effectiveness of communication strategies. • Stay updated on internal and external developments and industry trends to ensure timely and relevant communications and provide insights relevant to business strategies. • Manage and track communication budgets to ensure strategic allocation and cost efficiency.

• Lead the business operating cadence for the sales organization. • Coordinate weekly leadership meetings, quarterly business reviews, annual planning, and strategic planning sessions. • Translate VP priorities into measurable operational plans. • Track leadership commitments and organizational execution. • Manage governance processes supporting commercial performance. • Ensure Regional Directors execute against agreed priorities. • Develop organizational scorecards and leadership dashboards. • Monitor execution of strategic priorities. • Ensure consistency across regions regarding leadership expectations. • Measure business health and execution effectiveness. • Monitor coaching consistency across Regional Directors. • Identify organizational risks and recommend interventions. • Hold leadership teams accountable for execution milestones. • Prepare National level presentations • Build materials for: weekly leadership meetings, National Sales meetings, Live meetings, Town Halls, Quarterly Business Reviews. • Manage leadership communications • Develop organizational messaging. • Coordinate recognition and awards programs. • Support executive decision making through business insights. • Point person on GTM pull through and implementation • Coordinating strategic initiatives • Managing enterprise-level projects • Driving cross-functional alignment • Removing execution barriers. • Ensuring organizational readiness. • Facilitating communication between commercial functions. • Coordinate onboarding • Lead offboarding transactions • Support succession planning • Develop leadership capability initiatives • Improve organizational processes. • Lead continuous improvement initiatives. • Standardize leadership tools and resources • Support culture, engagement, and recognition initiatives.

• Primary point of contact for the execution of Data Management deliverables on assigned trials and programs. • Interprets and applies data strategy, ensures use of global program standards, coordinates and oversees Data Management study team members, and monitors and reports overall study progress. • Accountable for all Data Management activities throughout the study lifecycle, including oversight of all Data Management tasks and performing tasks such as document creation, data cleaning, and query management. • Develops and executes plans for risk identification and mitigation. • Assesses operational metrics to optimize process efficiency. • Oversees issue investigation and solution proposals using experience, judgement, and precedent. • Contributes to the development of Data Management process, including new process creation, process improvement, and innovation as applicable. • Manages quality and efficiency performance with vendors, including Data Management FSP team members and external vendor data providers. • Leads and participates in cross-functional collaborations, including study level activities and special projects or initiatives.

Role Description Reporting to the Head of Commercial & Alzheimer’s Disease, the Head of Sales is dedicated to driving the appropriate use of Biogen brands and services, improving the patient journey to care and customer satisfaction across the country, and ultimately growing Biogen Canada portfolio across all therapeutic areas and within all assigned sales territories. This role is responsible for leading, mentoring, and coaching the Partnership Account Lead (PAL) sales team to deliver successive and increasing levels of achievement in sales, customer service, and professional development. They will need to have a deep understanding of the pharmaceutical industry, with a proven track record in leading high performing teams and the ability to drive growth in both mature and new markets. Additionally, the Head of Sales will be responsible for establishing and tracking appropriate sales metrics, incentive plans and key performance indicators for sales teams across different therapeutic areas. This position requires close collaboration with cross-functional partners (Marketing, Medical Affairs, Market Access, Business Intelligence & Operations) to gather customer insights, assess market trends, identify, prioritize and capitalize on the right partnership opportunities with all relevant stakeholders. Responsibilities - Team Leadership: - Build and lead a high-performing sales organization by attracting top talent, setting clear expectations and goals, fostering a culture of collaboration, accountability, and executional excellence. - Manage talent through structured coaching, individual development plans, and ensuring both team and individual growth, making sure to manage low performance appropriately as well as develop talent. - Set clear performance metrics and accountability frameworks. - Market & Customer Engagement: - Develop strong relationships with key customers, healthcare providers and all relevant internal and external stakeholders. - Identify market trends, competitor activities and customer needs to refine sales strategies accordingly. - Sales Strategy & Execution: - Develop and implement national and regional sales strategy aligned with overall business objectives. - Responsible for growing the revenue of the Biogen Portfolio in all accounts, territories, and provinces, achieving relevant KPIs (sales targets, field force effectiveness measures, etc). - Define PAL teams’ annual goals and objectives as well as sales cycle’s critical success factors, targets and Sales Incentive Compensation Plan (SICP). - Mobilize the appropriate resources, collaborate with the cross-functional head-office team and field partners to develop and implement sound strategic account and provincial plans (SAP). - Lead business analysis, diagnosis, and account-specific action planning, deploy the appropriate course-corrective measures while tracking execution of initiatives. - Input on sales forecasts and track key sales metrics to ensure performance is in line with company goals. - Drive improvement in sales force execution and competitive capabilities. - Actively contribute to franchise strategic and business plan and monthly operational reviews through deep understanding of key customers/accounts dynamics and their evolving needs. - Cross-Functional Collaboration: - Work closely with all cross functional partners to ensure alignment of sales efforts with product launches, brand strategies and organizational objectives. - Compliance & Ethics: - Perform company business in compliance with relevant regulations, company policies and procedures. - Ensure that all sales activities are conducted in accordance with industry regulations, company policies and ethical standards. - Perform company business in compliance with relevant regulations, company policies, and procedures. - All other duties required. Qualifications - Bachelor’s degree required. Master’s degree strongly preferred. - Medical/pharmaceutical/science/business-related degree preferred. - 5+ years of experience as a people manager with experience transforming team performance and/or structure, delivering to a clear business goal. - 7+ years of experience in pharmaceutical/biotech sales. - 3+ years of experience in the head office environment, with an impact on field execution whether directly or indirectly. - Experience in launching products. - Demonstrated experience of leveraging the cross-functional environment to achieve superior customer outcomes. - Experience and knowledge of one of Biogen’s active therapeutic areas preferred but not required. - Fluent in English, both verbal and written with the ability to communicate effectively cross-functionally spanning all levels of the organization; proficiency in French a strong asset. Skills - Demonstrated ability to build a team and develop a high performing organization. - Customer-centric mindset capable of establishing strong and lasting rapport with customers for mutually beneficial outcomes. - Result-driven individual motivated by driving and exceeding annual brand performance objectives with proven and sustained track record. - Superior territory management acumen with strong analytical skills and advanced account planning competencies. - Consultative approach that is solution-oriented, connecting customer needs with brand objectives and ability to effectively problem solve in ambiguous or new situations. - Strong communicator that can influence through a variety of customer interaction channels (written, face-to-face and virtual). - Team player who can collaborate effectively with cross-functional partners assigned to the territory and leading territory initiatives without formal authority to ensure coordinated efforts. - Capable use of and advocacy for all applicable IVAs and other digital tools & technology in use to maximize sales targets and goals. Additional Requirements - Valid driver’s license. - Willingness to travel more than 50%. Direct Reports - 2 to 6 Specialty PALs - 3 Rare Disease PALs Work Location Designation for Role Remote Salary and Benefits The expected salary range for this position is $158,000 to $217,000 and is eligible for a discretionary sales bonus of 20%. 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 health care, retirement, paid time off, and ancillary programs such as a fully paid sabbatical after six years of service, Employee Stock Purchase Plan participation, education assistance, and more. 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. 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.

• Serve as the quality lead for assigned clinical studies and programs, providing guidance on GCP compliance and quality expectations. • Lead and support the Study Risk Assessment (SRA) process and proactively engage in inspection readiness activities. • Conduct and manage investigations, root cause analyses, and the development and oversight of CAPAs and Effectiveness Checks. • Collaborate with stakeholders to evaluate and escalate quality risks, and contribute to the development of mitigation strategies. • Partner with internal and external teams to ensure appropriate documentation, risk management, and audit/inspection response planning. • Support audit planning and regulatory inspection preparation, contributing to inspection management strategies and coordination. • Participate in cross-functional and process improvement initiatives to enhance quality system effectiveness across RD&M. • Review and approve controlled documents, CAPAs, and SOPs in alignment with quality standards and regulatory requirements.

• Building and maintaining strong relationships with medical business stakeholders to understand learning needs and implement effective solutions. • 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.

Role Description As a Senior Analyst, Statistical Programming, you will lead and oversee statistical programming activities both internally and via external vendors. You will be at the helm of applying data standards and producing high-quality analysis datasets, including tables, listings, figures, and electronic submission components. By partnering closely with Biostatistics, you will ensure the delivery of submission-ready statistical outputs. Your role includes providing essential input to the Programming Lead on study timelines, resource estimations, and milestone adherence. As a leader of a study team, you will communicate effectively and oversee quality, often serving as the sole functional representative from Statistical Programming. Your efforts will drive the implementation of the Data and Programming Strategy, while collaborating on process improvements and standard practice developments. This role is available on a remote working basis; candidates must be based full time in Ireland. Qualifications - Bachelor’s degree required, with a preference for a Master’s or PhD in Statistics or Mathematics. - Prior relevant work experience in data management and analysis. - Strong and proven experience in SAS Base programming and experience with SAS STAT, GRAPH, and MACRO. - Proven relevant industry experience, including clinical trial experience. - Clinical database experience. - Experience with CDISC and/or submissions. - Knowledge of drug development process, clinical trials, and submission requirements. - Familiarity with UNIX, R, Imaging and Genomics software packages, AI, and ML concepts. Requirements - Lead, coordinate, and manage the timely creation, oversight, and delivery of statistical programming activities and deliverables. - Author CDISC ADaM analysis data set specifications and identify potential data issues. - Manage end-to-end programming of deliverables from CRF collections through electronic submissions. - Serve as the Statistical Programming Lead to achieve study milestones and collaborate on resource needs. - Inform project team members about statistical programming requirements and deliverable status. - Participate in remedying departmental inefficiencies and contribute to process improvements. - Collaborate with statistics on defining and documenting endpoint algorithms. - Ensure compliance with ESUB standards in collaboration with SMEs in SSM. Benefits - Global team with a commitment to excellence and a pioneering spirit. - Stability and resources of a well-established business. - Opportunities for learning, growth, and expanding skills. - Work together to deliver life-changing medicines. - Culture of inclusion and belonging.

• Monitor the ICF Mailbox to identify, manage, and provide resolution or triage incoming requests; • Liaison with key ICF stakeholders to support resolution of complex ICF Issues. • As Subject Matter Expert, manage and provide resolution when IRBs/ECs have requests to modify a Biogen study ICF. • Assess requests to determine appropriate resolution and/or involvement of other stakeholders, e.g., legal counsel, data privacy officer, and pharmacovigilance scientists, for timely resolution. • Provide SME support during SSU at the study planning stage, as well as throughout the lifecycle of a clinical study through oversight of Biogen’s CRO Partners to ensure compliant and timely consent of subjects. • Analyze project/study team requirements, activity timelines and work scope to identify resource needs. • Bring ICM perspective to protocol authoring and write the Global Master ICF(s) when needed, depending on operating model. • Support monitoring of controlled process documents for compliance with Biogen policies and changes in laws and regulations. • Support monitoring of the informed consent process to ensure timeliness, accuracy, and compliance with regulatory obligations and internal KPIs. • Produce and analyze KPI metrics on compliance, performance, and quality. • Evaluate trends and identify areas of improvement. • Support cross-functional process improvement initiatives and ensure that the needs of the ICM process are considered. • Support the maintenance of Standard Operating Procedures and Work Instructions for the IC process, consistent with Quality Documentation requirements and GCO standards.

• Lead the development of the scientific narrative across planned rheumatology and dermatology indications, emphasizing unmet needs, disease mechanisms, and therapeutic actions. • Organize and execute scientific symposia at key global medical congresses, aligning with medical objectives. • Develop scientific content for use by field-based medical personnel, including educational "symposia in a box." • Create training materials for scientific and medical personnel, supporting onboarding and ongoing education in disease areas and therapeutic assets. • Chair the scientific narrative cross-functional working group to ensure alignment across departments and the fitness of content for its intended purpose. • Collaborate with clinical development leads, health economics and outcomes research (HEOR) leads, and publication leads to develop core scientific narratives and content. • Manage external medical communication vendors, including reviewing and approving statements of work (SOWs) and invoices. • Navigate complex situations to maintain scientific credibility and accuracy across all content developed for external use. • Ensure scientific resources are appropriate for various markets/regions, taking into account differing regulatory and compliance considerations. • Align content development with the core scientific platform, strategic publication plan, and global medical strategy.