Biogen

Director

• Provide pharmacometrics expertise to activities throughout the drug development lifecycle and effectively collaborate with cross functional teams
• Execute advanced pharmacometrics analyses, with emphasis on PK/PD modeling and simulation and exposure-response analysis for high priority programs
• Identify opportunities where modeling and simulation can advance the understanding of pharmacokinetics, pharmacodynamics, efficacy and safety
• Contribute to Model Informed Drug Development (MIDD) activities to support dose selection, regimen optimization and clinical trial design
• Communicate the pharmacometrics analysis results to program teams to support data-driven decision-making process
• Mentor and guide Clinical Pharmacology and Pharmacometrics colleagues on pharmacometrics analyses methodologies
• Serve as a lead author and key contributor for pharmacometrics sections of clinical and regulatory documents
• Publish in scientific journals and present at internal and external scientific events

Associate Scientific Director, Pharmacometrics

Compliance

• Define and own the global regulatory CMC strategy for drug-device combination products, diagnostics, and medical devices.
• Serve as the primary regulatory authority for complex, high-risk programs for all non-implantable device programs.
• Lead global regulatory strategy development and execution across development, registration, commercialization, and lifecycle management.
• Ensure quality, consistency, and timeliness of global CMC regulatory submissions across all regions.
• Act as the senior regulatory representative with global Health Authorities for device and combination product portfolios.
• Mentor and develop senior leaders and regulatory experts, fostering a culture of accountability and strategic thinking.
• Provide executive regulatory leadership for quality systems oversight, including change control and deviation management.
• Standardize processes and embed best practices to improve efficiency and scalability.
• Represent Biogen in external industry forums and influence regulatory standards and paradigms.

Senior Director, Global Regulatory CMC – Drug-Device Combination Products

Sales

• Achieve Region goals for the Biogen MS portfolio, including driving demand, retaining appropriate patients in therapy, and managing region budget
• Leverage coaching model to maximize the development of individuals' skills and abilities of team members to cultivate talent and deliver strong performance
• Flawlessly execute on key strategic priorities to achieve goals while upholding organizational values and standards
• Understanding market dynamics, business drivers, and corporate goals and resulting impact of those on region and strategy
• Purposeful collaboration internally and across the alliance to drive executional excellence, accountability, and sales performance through a focused and disciplined approach
• Develop strategies that uncover opportunities, address problems, or improve process, while leveraging data from multiple sources, to deliver impactful solutions for providers and patients
• Cultivating and supporting team’s development of strategic customer and stakeholder relationships and ensuring their perspective is the driving force behind all value-added business activities
• Planning and supporting the development of individuals' skills and abilities so that they can fulfill current or future job/role responsibilities more effectively
• Building a culture of compliance to ensure that all promotional activities are fully compliant with Company policies and procedures, applicable laws, regulations, and industry standards

Regional Sales Director, MS Specialty Franchise

Operations

• Lead internal initiatives that enhance Feasibility operations, strategy, communications, and team process efficiency.
• Identify opportunities to effectively scale and improve processes in support of continuous innovation.
• Drive process improvement, SOP/work instruction development, and change management.
• Enhance team use of project management tools and digital platforms.
• Provide leadership, mentorship, and (as applicable) line management to team members.
• Serve as feasibility strategy lead for Biogen clinical research programs
• Generate data-driven insights to support decision-making and operational trial performance.
• Support all relevant governance and planning meetings (e.g., Baseline Forum, business development due diligence, etc.)
• Engage with program and study teams to build and analyze what-if scenarios and enrollment modelling for impact to clinical trial operational designs, timelines and operational costs.
• Deliver critical, data-driven evaluation of the clinical trial protocol and supporting documents, to proactively identify study strengths and potential risks.
• Build, manage, and optimize SharePoint sites and knowledge management structures.
• Develop high-quality PowerPoint visualizations and support rebranding of Feasibility deliverables.
• Partner with Director to continue to build Center of Excellence by developing process standards and tools.
• Lead and support Director with the setting up of the general framework for team including general processes, standing meetings, overarching governance, goals, and/or presentations related to team objectives, etc.
• Continually evaluate industry landscape, lead identification, and assessment of innovative approaches.
• Identify, build, and manage effective relationships with academic, corporate and vendor consortiums, acting as key point of contact and subject matter expert (SME) on Biogen’s existing feasibility related portfolio of platforms, tools and systems.
• Act as deputy for FCoE Director (e.g., in study governance meetings) and/or act as thought partner for strategic direction of FCoE.

Associate Director, Feasibility – Internal Strategy, Operations & Process

Medical Director

• Lead the development of integrated global medical plans that drive asset strategy and scientific excellence in lupus
• Provide strong medical and scientific input to shape clinical, evidence generation, and launch readiness activities
• Interpret and communicate complex clinical data to both internal and external stakeholders with scientific precision and clarity
• Contribute to data generation efforts, including registrational, post-approval, and investigator-initiated studies
• Partner with cross-functional teams (Clinical Development, Regulatory, HEOR, Commercial, and others) to ensure alignment and scientific integrity
• Build and maintain trusted relationships with key external experts, professional societies, and advocacy groups
• Provide clinical leadership during congress planning, advisory boards, and educational activities
• Collaborate effectively across functions and with external partners to ensure scientific consistency and alignment across medical deliverables

Medical Director, Global Medical Affairs, Lupus

• Recruit, hire and on-board best-in-class launch team of Account Manager who will call on various customer types
• Leverage coaching model to maximize the development of individuals' skills and abilities of team members to cultivate talent and drive top performance
• Flawlessly execute on key strategic priorities to achieve goals while upholding organizational values and standards
• Specific initiatives may include: Purposeful collaboration internally and across the alliance to drive executional excellence, accountability, and sales performance through a focused and disciplined approach
• Lead team and navigate complex environments including affiliations, impact of care pathways and business level relationships that influence the way PPD is treated
• Cultivating and supporting team’s development of strategic customer and stakeholder relationships and ensuring their perspective is the driving force behind all value-added business activities
• Understanding market dynamics, business drivers, and corporate goals and resulting impact of those on region and strategy
• Planning and supporting the development of individuals' skills and abilities so that they can fulfill current or future job/role responsibilities more effectively
• Building a culture of compliance to ensure that all promotional activities are fully compliant with Company policies and procedures, applicable laws, regulations, and industry standards

Regional Sales Director – Women's Health

Manager

• 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

Family Access Manager

• Lead creation and maintenance of core, EU, and US labeling documents for approved products
• Support development of labeling for pipeline products
• Drive cross-functional labeling team discussions and secure senior management endorsement
• Propose and align labeling strategies with regulatory objectives
• Oversee distribution and tracking of Company Core Data Sheet (CDS) updates
• Deliver EU Product Information (EUPI) and US Prescribing Information (USPI) in line with regulations
• Oversee coordination of artwork and EMA linguistic reviews
• Ensure compliance with Health Authority timelines for SPL submissions and regional implementation
• Maintain labeling compliance, SOPs, and support audits
• Provide training and guidance on labeling processes and standards

Senior Manager, Global Labeling

• Responsible for developing and executing global regulatory strategies for assigned projects and programs.
• Support development of the preclinical and clinical development plan.
• Identify and assess regulatory risks associated with product development. Define mitigation or contingency strategies.
• Set strategic direction and leads global regulatory submission process with submission teams, including IND, CTA and core briefing packages.
• Prepare and/or lead global regulatory submissions including IND, pre-IND meeting package, CTA.
• Mentor Regulatory Managers.
• Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
• Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
• Provide input to Senior Management teams.
• Maintain a global view as part of the whole regulatory team.

Associate Director – Regulatory Affairs

Account Manager

• Develop and maintain critical relationships with OB/ GYN’s, Psychiatrists, Psychiatric NPs/PAs, Primary Care, other allied health professionals, and support staff
• Leverage account management competencies to increase screening of PPD, driving PPD focused initiatives, and impact PPD treatment pathways in affiliated health groups and systems
• Effectively communicate complex clinical data, protocols, screening and treatment pathways, market access policies as well as patient support services information to hcps and key non-clinical stakeholders
• Align Biogen’s product offerings to meet the evolving needs of HCPs in a productive and compliant manner

Neuropsychiatry Account Manager – Women's Health

Analyst

• The Senior Principal Analyst, Statistical Programming is primarily responsible for leading the Management of several study SDTM operating activities and deliverables (aCRF, specifications, datasets, define.xml, SDRG, etc) under an FSP operating model and at the Portfolio Level.
• Collaborating cross-functionally within Biometrics, he/she may serve as a leader or provide support in developing and implementing best practices and processes for optimization of the SDTM delivery model.
• He/She reviews the study pipeline and serves as a first line for routine day-to-day activities for FSP resources, and review of metrics related to SDTM quality and timelines.
• This role will ensure quality SDTM package delivery to the Statistical Programming group through oversight of the model.
• He/she leads or participates in cross-functional teams to coordinate ADaM Data standardization efforts across the Quantitative Sciences and Development Organization (QSDO).
• He/she will be instrumental and directly contribute/develop in building ADaM templates.
• Acting as an ADaM consultant, he/she supports and educates colleagues and clinical study teams across QSDO.
• He/she participates in external industry data standards development teams, as appropriate, and contributes to the development of clinical data standard models on QSDO's behalf.