Regeneron

Manager

• developing accurate and timely total investigator grants and per subject cost estimates
• reviewing CROs’ and/or sites’ proposed changes to the study-specific budget parameters
• ensuring the delivery of high quality, compliant, effective, and timely deliverables
• maintaining productive relationships with internal client groups
• leading ongoing process improvements and training sessions
• onboarding, training, and mentoring peers
• potentially having direct reports

Manager, Site Contracts

Account Manager

• Represent the entire Regeneron ophthalmology product portfolio
• Connect to key business decision-makers and all other relevant Key Opinion Leaders (KOLs) within assigned accounts
• Act as a critical liaison between customers and Regeneron
• Educate and influence customers including large provider practices and private equity groups
• Lead and appropriately administer and pull-through provider contracts
• Engage customers at regional and national retinal meetings
• Deliver regular contract performance updates to customers
• Perform quarterly business reviews with customers

Director, GPO & Account Management

Director

• Responsible for regional hiring, deployment, and leadership of hematology focused Associate Directors – Field Medical (MSLs)
• Supervise team member development and evaluate performance
• Provide oversight of all activities in accordance with current regulatory and health care guidelines
• Provide scientific exchange and collaboration with therapeutic area opinion leaders
• Develop and manage company and investigator sponsored clinical trials
• Develop field strategies for healthcare professionals
• Create and implement field collaborative strategies
• Engage healthcare professionals and attend medical conferences

Director, Field Medical Affairs – Hematology

Compliance

• Provide leadership on global regulatory activities for the assigned products.
• Focus on Clinical Regulatory filings and provide regulatory leadership on project teams.
• Supply, lead and/or supervise IND/CTA and BLA submissions activities.
• Provide interpretation of regulatory authorities’ feedback, policies and guidelines.
• Lead the development of regulatory strategic plans in conjunction with project teams or through your reports.
• Own the preparation of major clinical submissions required for regulatory approval.
• Work with project teams to resolve complex project issues.
• Utilize regulatory expertise and knowledge of regulatory requirements and regulations to interpret, plan, and communicate requirements.
• Assure compliance with regulations and project team timelines.
• Provide interpersonal support and lead personnel.

Director, Regulatory Affairs Strategy – Oncology

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation for any identified signals and author the safety evaluation reports
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
• Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
• Participate in other risk management activities as appropriate for assigned compounds
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

Senior Manager, Global Patient Safety – General Medicine

Software Engineer

• Driving Tier 0 resiliency roadmaps — compute, storage, network, cloud, security, and automation frameworks
• Representing DR at Solution Design Engineering Reviews to embed recovery standards into every new or changed system
• Authoring recovery architectures for cyber-resilience, including offline/ransomware-protection strategies
• Leading enterprise-wide tabletop and hands-on recovery tests; analyzing results and closing gaps
• Developing RFPs and evaluating innovative technologies to improve recovery speed, scale, and automation

Senior Principal Disaster Recovery Architecture – Engineering

• Engaging in meaningful and strategic discussions to gather insights & share clinical information with assigned key thought leaders
• Sharing with Marketing and other functional groups the insights gleaned from interactions with thought leaders
• Supporting congress planning efforts, including sponsorship recommendations and identification of speakers for product theaters
• Coordinating thought leader engagements for senior executives at local/regional/national conferences and/or during day-to-day business
• Conducting substantive business discussions related to on-label product information, disease state, and general corporate overviews
• Embracing a customer-centric, needs-based approach to drive strategic thought leader engagements
• Developing/maintaining list of key thought leaders in the assigned geography
• Assisting with thought leader development
• Supporting speaker bureau efforts, including identification of potential speakers, contracting, managing logistics related to speaker training, and providing feedback to speakers to improve presentation effectiveness
• Supporting regional/national advisory board and advisory council planning efforts, making strategic recommendations on potential thought leader participants and liaising with selected thought leaders
• Supporting monthly field team calls, gathering feedback on speaker programs & p2p content

Associate Director, Thought Leader Liaison – Oncology

Content Writer

• Drafting and managing reviews of submission documents for nonclinical pharmacology and toxicology
• Collaborating with scientists to interpret data and develop key messaging
• Authoring and managing internal reviews of nonclinical study reports
• Driving documents through comment reconciliation among key stakeholders
• Advancing multiple projects while adhering to submission timelines
• Participating in process improvement and training junior writers

Scientific Writer

Medical Director

• Acts as medical expert and leader in interactions with external stakeholders
• Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
• Designs and develops more efficient and innovative, yet robust Phase 2/3 programs.
• Works closely with discovery teams to provide input on the next generation of targets in the field and leads the development of plans for Phase 1 clinical testing for initial characterization of the molecules PK/PD and safety.
• Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety.
• Plans and executes publication and clinical communication strategy in coordination with Publications team.
• Provides input to key external presentations.
• Ensures quality of all clinical documents (e.g., Investigators’ Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents).
• Develops written responses to regulatory agency questions and regulatory submission documents.

Senior Medical Director, Clinical Development, Cardiovascular/Metabolism

• guide and define the culture, structure, and strategic direction of Regeneron’s Rare Neurology TLL Team
• build a high performing team, capable of generating quality insights with Thought Leaders
• create a compliant environment which challenges, motivates and develops team members to reach optimum performance and potential
• set clear objectives, coach/mentor, and assess performance and skill-level to develop future leaders within Regeneron
• provide strategic customer insights to the Marketing Leadership team to assist in the further development of the Rare Neurology brand strategy
• work collaboratively with multiple matrix partners in developing and refining business plans to achieve brand objectives
• manage budget and TLL operations to ensure the TLL team is appropriately resourced
• champion and lead the TLL team in a compliant manner
• build and cultivate collaboration within alliance

Director, Thought Leader Liaison – Neuro

• Oversees country and/or regional level PV execution within their assigned region
• Ensures that local safety activities are performed in accordance with global standards
• Tracks local process status, changes, and risks to drive consistency and continuous improvement
• Develops innovative approaches to core activities that integrate in new technologies, including AI
• Ensures country compliance with the global PV quality system
• Serves as local safety PoC to coordinate with global teams
• Guides and informs global teams on local requirements
• Shapes compliant programs that provide high quality adverse event reports
• Builds, coaches, and scales a high-performing team

Director, Pharmacovigilance Hub

Operations

• Serve as the single point of accountability for Regeneron’s global-to-local pharmacovigilance model
• Ensure consistency, compliance and operational excellence across all regions and countries
• Define execution scope for regional PV Hubs, determining which processes require localization to meet requirements versus which can be executed through centralized global processes
• Establish governance framework for local process adaptation
• Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI
• Coordinate across key GPS functions (e.g., QPPV, Case Management, Quality & Compliance)
• Adapt the international model to fit changing business needs
• Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines

Executive Director – Worldwide Operations Office, Pharmacovigilance

• Responsible for leading the development, implementation, and governance of AI capabilities that deliver measurable operational value and align to broader pharmacovigilance (PV) technology strategy
• Define and communicate the AI function vision, strategy and governance structure in alignment with business goals
• Identify opportunities to leverage AI across PV processes to improve efficiency, insights, and scalability
• Support the definition and execution of the GPS digital innovation strategy, providing AI expertise and technical input to the Executive Director, PV Innovation, GPS
• Translate PV business requirements into scalable AI-enabled solutions and digital capabilities
• Establish and maintain architecture, data, security, and Responsible AI standards and guardrails for PV AI initiatives
• Oversee the implementation and scaling of AI solutions across GPS, ensuring solutions are fit-for-purpose and deliver measurable value
• Ensure AI-enabled solutions comply with GxP, validation, data integrity, privacy, and regulatory requirements
• Partner with key technology teams (e.g., GD IT, Cloud, Dev Ops, AI & Digital, Compliance) to ensure technology alignment, platform integration, and scalable deployment
• Provide operational insights and emerging technology opportunities to inform the broader PV digital innovation roadmap
• Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines.

Director, PV Innovation

• Support Health Care Practitioner offices in obtaining appropriate access to Regeneron products
• Work cross-functionally and collaboratively with Regeneron and Alliance sales organizations
• Complete a Strategic tactical plan for execution of Alliance products access and reimbursement initiatives
• Monitor personal performance against established parameters
• Provide appropriate payer and specialty pharmacy support services

Field Reimbursement Manager – Immunology

• Build and develop a high performing, high integrity, high quality sales team and provide overall leadership to the team
• Responsible for meeting and/or exceeding assigned sales objectives and ensuring actions plans are aligned to the strategic initiatives of the brand
• Lead regional sales force activities including hiring, training, performance evaluation and development while ensuring compliance to corporate policies
• Ensure each employee is trained on and effectively implementing customer education
• Communicate most current knowledge of the industry and competitor products to regional teams
• Ensure participation in industry related trade shows, meetings, conferences, etc
• Analyze sales and customer data to ensure appropriate resources are deployed in the region
• Allocate and manage the region's budget and utilization of promotional resources
• Ensure strong, consistent performance that consistently meet or exceed brand objectives and product sales goals while consistently demonstrating accountability for all results
• Build the Company’s credibility and relationships with key customers (e.g. Regional, local clinical experts, advocacy groups etc.) and their staffs in the field of Rare Neurology
• Ensure the Rare Neurology Medical Specialists are viewed by their customers as clinical experts in the field of Rare Neurology
• Develop and execute an Incentive Compensation plan for field team in accordance with corporate objectives and within guidelines in a compliant manner
• Partner with multiple internal stakeholders to proactively analyze and address market dynamics and trends that support brand and collaboration objectives
• Demonstrate strong understanding of Payer environment, reimbursement and challenges within payer markets including: government programs, managed health care and evolving health care systems