Simulations Plus

Role Description The Senior Program Manager will lead cross-functional delivery operations across a portfolio of scientific software products supporting modeling and simulation for drug discovery and development. This role operates at the intersection of product strategy, agile program management, product enablement, operational execution, and software delivery coordination ensuring that product priorities translate into measurable customer and business outcomes. The ideal candidate will help coordinate software delivery across interconnected product teams, align roadmap priorities with customer and scientific requirements, and drive operational excellence throughout the product development lifecycle. This individual will work closely with stakeholders to support agile execution, validation readiness, release planning, and product enablement initiatives. Job Responsibilities - Product and Portfolio Operations - Partner with Product Management and Product Enablement leadership to translate strategic priorities, customer requirements, and ROI objectives into executable delivery plans and sprint priorities. - Support portfolio-level coordination across multiple scientific software products and interconnected product initiatives. - Facilitate roadmap reviews, prioritization discussions, backlog refinement, and operational planning activities across cross-functional stakeholders. - Drive operational governance processes that improve delivery visibility, prioritization discipline, and execution accountability. - Monitor program risks, resource constraints, delivery dependencies, and timeline impacts across concurrent initiatives. - Agile Program Management - Lead agile program execution across multiple software delivery initiatives within a scientific software and product operations environment. - Coordinate sprint planning, backlog management, release readiness, and delivery tracking in collaboration with Product Owners and cross-functional product teams. - Ensure sprint objectives, delivery timelines, and scope commitments remain aligned with organizational priorities and customer expectations. - Facilitate agile ceremonies including sprint planning, retrospectives, dependency reviews, and cross-functional coordination meetings. - Drive continuous improvement initiatives related to agile delivery processes, operational workflows, and program execution standards. - Technical and Ecosystem Coordination - Coordinate technical dependencies across APIs, interoperable modeling platforms, and integrated scientific software workflows. - Support alignment across interconnected software products, platform integrations, and customer-facing product capabilities. - Partner with technical product teams to identify integration risks, sequencing considerations, and delivery dependencies impacting release timelines. - Ensure software delivery activities support scalability, interoperability, operational readiness, and customer requirements. - Maintain visibility into scope changes, dependency impacts, and cross-product coordination requirements. - Cross-Functional Collaboration - Serve as a central coordination point across Product Management, Product Enablement, QMS, Learning Services, Marketing, Operations, and customer-facing teams. - Partner with Learning Services to align training materials, customer enablement resources, and release readiness activities with deployment schedules. - Collaborate with Marketing teams to support release communications, feature launch coordination, and customer adoption initiatives. - Facilitate alignment between technical and non-technical stakeholders to ensure shared understanding of priorities, risks, timelines, and business outcomes. - Drive operational transparency through structured reporting, executive updates, and stakeholder communication processes. - Customer and Stakeholder Alignment - Ensure customer feedback, operational requirements, and business priorities are incorporated into product planning and release coordination activities. - Balance strategic organizational objectives with customer-centric delivery outcomes and product usability considerations. - Partner with internal and external stakeholders to manage expectations, communicate release timelines, and mitigate operational risks. - Support executive decision-making through delivery insights, prioritization recommendations, and program performance reporting. - Foster collaborative relationships across technical, operational, and customer-facing teams. - Release Planning & Execution - Own cross-functional release coordination processes including scope validation, dependency tracking, timeline management, and readiness reviews. - Ensure software releases are delivered on schedule, within agreed scope parameters, and aligned with customer and organizational priorities. - Coordinate release communications, deployment readiness activities, stakeholder notifications, and post-release follow-up efforts. - Track release metrics, operational outcomes, and delivery effectiveness to support continuous improvement initiatives. - Identify and proactively mitigate risks that may impact software quality, release schedules, or customer adoption. - Quality and Validation Coordination - Partner with Quality Management Systems (QMS) stakeholders to support software validation planning, documentation readiness, and release compliance activities. - Coordinate cross-functional validation activities associated with software releases, enhancements, and regulated product updates. - Ensure delivery timelines appropriately incorporate validation requirements, documentation dependencies, and quality review processes. - Facilitate alignment between product delivery teams, QMS stakeholders, and operational leadership to support compliant release execution. - Track validation readiness, release approvals, and quality-related dependencies that may impact deployment schedules or customer delivery commitments. - Support continuous improvement initiatives related to software quality processes, operational governance, and release management standards. - Other duties as assigned. Qualifications - 12+ years of experience in Program Management, Product Operations, Agile Delivery, or related software delivery leadership roles. - Proven experience leading cross-functional software delivery initiatives within SaaS, scientific software, or enterprise technology organizations. - Strong expertise in agile methodologies or hybrid agile delivery frameworks. - Demonstrated ability to translate strategic business priorities and ROI objectives into executable sprint and release plans. - Experience coordinating complex software delivery programs involving APIs, integrations, and multi-team dependencies. - Strong operational planning, prioritization, and execution management capabilities. - Exceptional communication and stakeholder management skills across technical, operational, and executive audiences. - Experience managing delivery scope, release coordination, timelines, and risk mitigation activities. - Experience working within regulated software environments requiring coordination with Quality Management Systems (QMS), software validation processes, or controlled release procedures. - Familiarity with software quality governance, validation documentation workflows, and cross-functional release readiness activities. - Ability to operate effectively in fast-paced, highly collaborative, and evolving product and technology environments. - Occasional travel for meetings and training. Preferred Qualifications - PMP, Scrum Master, Product Owner, or Agile certification(s). - Experience supporting scientific software products used within pharmaceutical, biotechnology, clinical research, or regulated drug development environments. - Familiarity with GxP, software validation practices, or regulated SDLC processes supporting life sciences applications. - Experience supporting SaaS platforms, modeling and simulation products, or scientific software ecosystems. - Strong understanding of API integration workflows and cross-product interoperability coordination. - Background in Product Operations, Portfolio Management, or Product Delivery. - Experience partnering with customer enablement, training, or go-to-market teams during software release cycles. - Familiarity with Jira, Confluence, or similar agile delivery and portfolio management platforms. Education - Bachelor’s degree in project management, business, science, or related field. - Master’s degree in project management, business, science, or related field a plus.

Role Description The Vice President, Medical Communications will shape the strategic direction of our family of agencies dedicated to serving the life sciences industry. The role will lead the accounts team, medical director, and writers while driving client accountability, managing relationships, and ensuring the delivery of high-quality services and products. Job Responsibilities: - Provide strategic leadership and direction for the account management and medical team, ensuring alignment with overall company goals. - Oversee the development and execution of account strategies, ensuring they align with clients' objectives and help achieve their goals in the life sciences sector. - Lead the medical team to ensure accurate, timely, and impactful content and materials. - Ensure teams work cohesively and cross-functionally to deliver integrated solutions to clients. - Develop and manage department budgets, forecasts, and financial plans. - Monitor performance metrics, implementing necessary changes to improve efficiency, effectiveness, and quality. - Partner with stakeholders for continuous improvement efforts for new technologies or processes. - Ensure operations comply with relevant laws, regulations, and industry standards. - Participate in strategic planning and decision-making at the executive level to develop and implement operational plans that align with the company's strategic goals. - Other duties as assigned. Qualifications - 10+ years of commercial accounts leadership experience. - 5+ years of people management experience. - Proven experience in senior leadership. - Inspire and motivate teams to achieve targets. - Strategic thinker with strong analytical skills. - Track record of developing and executing successful sales strategies. - Results-driven mindset with a focus on revenue growth, customer satisfaction, and business profitability. - Knowledge of the industry, market dynamics, and competitive landscape related to the commercial accounts segment. - Proficiency in CRM systems and sales forecasting tools. - Strong computer and software skills. - Influence and collaborate at all levels of the organization. - Excellent written and verbal communication skills. - Thorough knowledge and understanding of the industry and company offerings. - Excellent organization and time management skills. - Strong problem-solving skills. - Strong presentation and interpersonal skills to drive business growth efforts. Requirements - Bachelor’s degree in sales, marketing, life sciences, or related field. - Masters or PhD in life sciences or PharmD preferred. Benefits - Fully remote work. - Flexible schedules. - Generous vacation policy. - Affordable health coverage. - Stock options. - Annual bonus.

Role Description The Associate Product Specialist will support the development of GastroPlus and contribute to customer enablement activities and product support under the guidance of senior team members while helping to shape the future of physiologically based pharmacokinetic (PBPK) and biopharmaceutics (PBBM) modeling and simulation. This role offers structured learning opportunities and mentorship to build foundational skills in product, technical, and customer support while learning our software products and implementation processes. GastroPlus is a powerful, industry leading, PBPK and PBBM platform that supports applications from early discovery right through to regulatory submission. Job Responsibilities - Product Support - Translate user needs and scientific advancements into specifications for product improvement - Work with the development team to define and test product features - Contribute to the development and running of the automated testing suite - Customer Support - Present GastroPlus to potential customers and scientific audiences - Respond to customer inquiries - Escalate technical issues appropriately - Assist with user onboarding - Support, develop and deliver training sessions - Documentation Support - Update existing materials - Review documentation for accuracy - Create simple user guides - Format and organize content - Team Collaboration - Participate in team meetings and contribute to internal knowledge sharing - Contribute to the scientific growth of the team - Support process improvements - Maintain team documentation - Other duties as assigned Qualifications - Previous research or professional experience in PBPK/PBBM modeling preferred - Excellent English written and oral communication skills - Basic understanding of software applications - Strong learning agility - Detail-orientated approach - Critical thinking and problem-solving ability - Ability to follow technical instructions - Proactive, self-starting team player able to organize own time successfully - Basic understanding of software concepts - Proficiency with Microsoft Office Suite Preferred Qualifications - Comfortable presenting scientific material to different audiences - Experience writing scientific publications, case studies or tutorials - GastroPlus experience - Python or R experience Education - Masters or PhD in PBPK/PBBM modeling, computational engineering, life sciences, or related field preferred Benefits - Hybrid work options - Flexible schedules - Stock options - Annual bonus

Role Description The Account Manager – Client Services (MedComm, Life Sciences) will support clients in the biotech, pharmaceutical, and life sciences industries. The role is responsible for supporting client relationships and ensuring the successful execution of deliverables while contributing to establish long-term partnerships through operational excellence and exceptional communication. Job Responsibilities: - Support the team in a variety of projects including advisory boards, speaker trainings, industry-sponsored events, and content-based projects. - Coordinate and execute project delivery while identifying strategic solutions aligned with client and business goals. - Guide day-to-day project management and collaborate with functional departments to contribute to the timely delivery of programming, services, and solutions. - Attend and manage client-related meetings and communications, including coordination and scheduling status/ad hoc calls, creating agendas, capturing notes, and post-meeting follow-up action items. - Assist in the submission of required assets for material review and approval into required client system platforms (e.g. Medical-Legal-Regulatory Review, Advisory Boards System, etc.). - Collaborate with client stakeholders, such as marketing, legal, regulatory and medical teams, and other stakeholders including physician advisors/consultants. - Conduct background research related to projects, including utilizing the medical/scientific literature, treatment guidelines, and market research results. - Understand disease states, market dynamics, the professional medical education competitive landscape, and current medical and/or regulatory issues related to various products. - Participate in discussions regarding the creation of departmental SOPs addressing processes and procedures necessary to achieve organizational objectives. - Support capturing and managing conference deliverables such as posters and sessions, ensuring accuracy, context, and alignment with client requests. - Other duties as assigned. Qualifications - Excellent verbal and written English skills. - 2+ years of pharmaceutical/biotechnology industry experience in a similar role preferred. - Experience in medical communications, healthcare marketing, or the life sciences industry strongly preferred. - General knowledge of medical sciences, healthcare delivery, and the pharmaceutical/biotechnology industry. - Experience with Veeva Vault - PromoMats system is a plus. - Ability to adhere to multiple competing timelines and project deadlines. - Strong project management skills. - Excellent organizational and time management skills. - Strong attention to detail. - Excellent interpersonal skills. - Ability to interact successfully with a multifunctional team. - Self-directed, works well under pressure with minimal supervision. - Produce high-quality work while managing shifting priorities. - Deliver work in a timely manner and within budget. - Maintain an objective and professional attitude. - Ability to work in a fast-paced, collaborative environment. - Good computer skills. - Occasional travel required. Education - Bachelor’s degree in marketing, communications, business, molecular biology, pharmacology, or related field. Benefits - Fully remote work. - Flexible schedules. - Generous vacation policy. - Affordable health coverage. - Stock options. - Annual bonus.

Role Description The Senior Director, Pharmacometrics will lead cross-functional project teams through the successful completion of client goals. This role will engage in activities ranging from consultations on study design through the development and evaluation of models, the performance of simulations, and the presentation of results. - Lead, manage, and collaborate effectively with cross-functional project teams to successfully support client requests, providing strategic direction regarding the interpretation and integration of modeling and simulation results and findings. - Serve as the main point of contact for assigned clients and projects, providing valuable insight regarding the optimal use of modeling and simulation in drug development programs, including study design considerations through the development and evaluation of models, and appropriate messaging to address critical questions. - Build partnerships with clients to promote synergistic working relationships. - Use state-of-the-art software to independently develop, evaluate and apply complex population PK, PK/PD and exposure-response models and simulations. - Formulate pharmacometric data analysis plans and data requirement documents, ensuring appropriateness of methods for data handling and analysis and compliance with current global regulatory guidance. - Write pharmacometric reports and regulatory documents. - Share scientific knowledge and skills with other staff members; mentor junior level scientists; may supervise assigned scientists. - Lead or contribute to the development of standard processes and methods. - Teach workshops and develop new training material. - Promote software and consulting service offerings; may assist in developing proposals and work scopes. - Serve as a role model for the advancement of consulting services. - Other duties as assigned. Qualifications - 12+ years of population PK and PK/PD professional modeling experience preferred. - Proficiency in Monolix, NONMEM, and R. - Professional experience in application of Pharmacometrics to Clinical Pharmacology preferred. - Proficient at developing and delivering presentations. - Highly self-motivated and willing to take on challenges. - Possess excellent critical-thinking, problem-solving, and interpersonal skills. - Strong verbal and written communication. - Some travel required for meetings, trainings, and conferences. Education - Master’s degree in pharmacometrics, PK/PD, pharmaceutics, pharmacology, statistics, engineering, or related field. - PhD in pharmacometrics, PK/PD, pharmaceutics, pharmacology, statistics, engineering, or related field preferred. Benefits - Fully remote work. - Flexible schedules. - Generous vacation policy. - Affordable health coverage. - Stock options. - Annual bonus.

Role Description The Assistant Vice President, Quantitative Clinical Pharmacology will lead multi-disciplinary project teams through the successful completion of client goals. This role will engage in activities including: - Developing MIDD-based clinical pharmacology strategies for client development programs - Serving as an embedded clinical pharmacology representative for clients - Supporting clinical pharmacology objectives by providing consultations on study design - Developing and evaluating models, performing simulations, and presenting results Job Responsibilities - Lead and collaborate with multi-disciplinary teams to implement quantitative clinical pharmacology projects/programs - Provide clinical pharmacology and pharmacometric consultation to other company projects/programs - Support clinical pharmacology-related components of clinical study protocols, study conduct, data analysis, and report writing - Provide guidance to clients regarding regulatory strategy and participate in regulatory interactions with health authorities - Support project teams with advanced PBPK, population PK, PK/PD, and exposure-response modeling and simulation - Apply advanced scientific knowledge and expertise to assigned programs and projects - Ensure appropriateness of methods, integrity of data, and accuracy of results - Maintain communication between the company and clients throughout project execution - Engage with clients regarding strategic approach, presentation of results, regulatory implications, and messaging of findings - Initiate and maintain positive, productive, and profitable client relationships - Prepare final technical reports, synopses, executive summaries, and other regulatory documents - Ensure provision of advanced literature searches for project/program-related information - Provide sophisticated written interpretation of material and integrate research findings - Share findings with internal and external project teams - Prepare abstracts, presentations, and publication-ready manuscripts - May supervise junior scientists; provide mentoring and feedback - Engage in cross-functional discussions of scientific strategy - Serve as a subject matter expert resource for the Business Development Team - Integrate knowledge of PBPK, population PK, and PK/PD for drug development guidance - Stay current with pharmacometric and clinical pharmacology literature - Expand scientific expertise through attendance and presentation at conferences - Develop and teach at GastroPlus, MONOLIX, and other workshops and courses - Other duties as assigned Qualifications - 12+ years of applied clinical pharmacology experience - 8+ years of leading projects, programs, and scientists preferred - Experience as a clinical pharmacologist in a drug development organization preferred - Previous supervision of junior clinical pharmacologists and pharmacometricians preferred - Strong experience presenting scientific results to professional audiences - Extensive experience preparing, submitting, and receiving approval for publications - Population pharmacokinetic and pharmacokinetic/pharmacodynamic modeling experience - Non-compartmental and compartmental pharmacokinetics experience - Mechanistic physiologically based pharmacokinetic modeling experience - Excellent communication, presentation, and leadership skills - Relationship-building skills with the ability to work closely with project leaders - Strong organization skills and ability to handle multiple tasks simultaneously - Ability to work well under tight deadlines - Great critical-thinking and problem-solving skills - Occasional travel for meetings, trainings, and conferences Education - Master’s degree in pharmacometrics, PK/PD, pharmaceutics, pharmacology, statistics, engineering, or related field - PharmD, PhD in pharmacometrics, PK/PD, pharmaceutics, pharmacology, statistics, engineering, or related field preferred - Advanced clinical pharmacology related training preferred Benefits - Fully remote work - Flexible schedules - Generous vacation policy - Affordable health coverage - Stock options - Annual bonus

Role Description The Senior Principal Product Enablement Specialist, AI will serve as a senior technical enablement expert responsible for enabling AI-powered platform capabilities across the Simulations Plus ecosystem. This role focuses on the enablement, implementation, and operational readiness of AI agents, AI-assisted workflows, and the composition layer that supports cross-product functionality. This individual contributor role provides the opportunity to shape how AI capabilities are delivered and adopted across products while remaining hands-on with implementation, testing, and customer enablement. Job Responsibilities - AI Product Enablement Leadership - Define and establish enablement best practices for AI-powered capabilities across the ecosystem - AI composition layer integration - Shared AI agents (e.g., data agents, reporting agents) - Cross-product AI workflows - Develop implementation frameworks for deploying AI capabilities consistently across products - Establish standards for AI feature testing, validation, and operational readiness - Create reusable implementation patterns and configuration templates for AI capabilities - Drive standardization of AI documentation, enablement materials, and training resources - AI Capability Implementation - Implement AI agents and AI-assisted features within product workflows - Integrate AI agents with product APIs and services - Configure AI pipelines and execution environments - Adapt shared AI capabilities to product-specific contexts - Collaborate with engineering and product teams to operationalize AI features - Support integration of shared AI services into multiple product environments - Identify and resolve implementation challenges during development and deployment - Ensure AI features function consistently across the product ecosystem - AI Feature Testing and Validation - Develop and execute testing frameworks for AI-powered product capabilities - Functional testing of AI agents - Evaluation pipelines for AI outputs - Reliability and performance testing - Implement human-in-the-loop validation strategies for AI-assisted workflows - Identify edge cases and failure modes in AI-driven features - Work with engineering teams to improve reliability and monitoring of AI systems - Establish quality assurance practices specific to AI-enabled product features - Documentation and Training - Develop comprehensive documentation for AI-enabled product capabilities - Architecture and usage documentation - Implementation and integration guides - Troubleshooting resources - Create training curricula for internal teams and customers adopting AI capabilities - Produce educational materials explaining AI workflows and agent capabilities - Ensure documentation remains aligned with evolving AI platform capabilities - Support onboarding and training of teams implementing AI-powered workflows - Operational Support and Troubleshooting - Serve as a technical escalation point for complex AI feature deployments - Diagnose and resolve issues related to AI agents, pipelines, and workflows - Support services and support teams in troubleshooting AI-enabled functionality - Identify patterns in operational issues to improve AI reliability and usability - Contribute improvements to operational practices for AI-powered features - Cross-Product Collaboration - Collaborate with Product and Engineering teams to ensure consistent AI capability delivery - Work with Services and Support teams to capture operational insights from AI deployments - Provide feedback to product teams on usability and adoption challenges - Identify opportunities to reuse AI capabilities across products and workflows - Help maintain alignment between AI platform capabilities and product-level implementations Qualifications - 7+ years of experience working with AI-enabled software products or AI platforms - Experience implementing LLM-based systems, AI agents, or AI pipelines - Experience with evaluation frameworks for AI outputs - Strong understanding of AI reliability, monitoring, and operational practices - Ability to translate AI capabilities into practical product functionality - Experience implementing complex software systems or platform capabilities - Working with APIs and distributed services - Strong programming or scripting experience (Python or similar languages commonly used in AI development) - Experience working with modern AI tooling and development frameworks - Demonstrated ability to support multiple product environments simultaneously - Strong technical communication and documentation skills - Ability to collaborate effectively with product, engineering, and operations teams - Strong organizational skills and ability to manage multiple initiatives Preferred Qualifications - Experience working with AI agent architectures and orchestration frameworks - Experience implementing retrieval-augmented generation or knowledge-based AI systems - Familiarity with AI evaluation pipelines and observability tooling - Experience deploying AI capabilities in enterprise software environments - Familiarity with cloud-based AI infrastructure and deployment models - Experience supporting cross-product platforms or shared services - Understanding of API-based product architectures Education - Bachelor’s degree in computer science, data science, artificial intelligence, or related field - Masters or PhD in computer science, data science, artificial intelligence, or related field preferred

Role Description The Senior Meeting Planner will coordinate and manage in-person and virtual meetings, conferences, and events for clients within the life sciences industry. The role plans and executes domestic and international meetings including logistics, budgeting, vendor management, and onsite coordination. Job Responsibilities - Meeting and Event Planning - Plan and coordinate meetings, conferences, and events - Select venue, negotiate contract, and coordinate consulting agreement - Manage travel, lodging, food/beverage, audio-visual, room-set, meeting materials, and budget tracking - Collaborate with internal stakeholders to define meeting objectives, agenda, and attendee requirements - Develop and manage project timelines, budgets, and checklists - Ensure planning aspects and interactions with healthcare professionals are compliant - Vendor Management - Source, select, and manage vendors and suppliers including caterers, audio-visual providers, and transportation services - Negotiate contracts, review proposals, and ensure adherence to budget - Coordinate with vendors to ensure timely delivery of services and resolve issues - Logistics Management - Manage meeting recruitment and registration - Ensure consulting agreements and W9s are signed and fully executed prior to meetings - Coordinate travel arrangements, accommodations, and ground transportation - Arrange audio-visual equipment, signage, and other event materials - Manage room setup, seating arrangements, and other onsite logistics - Budget Management - May develop and manage event budgets including cost estimation, tracking, and reporting - Monitor expenses throughout the planning process to ensure adherence to budget - Identify opportunities for cost savings and negotiate favorable pricing with vendors - Communication and Documentation - Serve as main point of contact for participants, address inquiries, provide information, and manage registrations - Prepare and distribute event-related materials, such as invitations, agendas, and presentations - Maintain accurate records including attendee lists, expenses, and post-event evaluations - Onsite Event Management - Oversee onsite event coordination ensuring logistical arrangements are in place and executed effectively - Manage event staff and volunteers providing guidance, instructions, and support - Troubleshoot and resolve issues that may arise during events - Post-Event Evaluation - Collect feedback from participants and stakeholders to evaluate the success of meetings and events - Identify opportunities for continuous improvement on logistics and implement changes based on lessons learned - Post-Meeting Payments, Reconciliation, and Reporting - Submit honorarium payment requests and expense reimbursements for processing - Work with finance to fully reconcile event costs - Provide required documentation for client specific post-meeting reports - Other duties as assigned Qualifications - 6+ years of meeting planning, event management, or related experience - PhRMA meeting planning experience required - Event management software and online registration platforms (e.g. Cvent) experience is required - Strong organizational and project management skills - Manage multiple priorities and meet deadlines - Excellent verbal and written communication skills - Strong interpersonal skills - Interact successfully with stakeholders at all levels - Attention to detail and maintain a high level of accuracy in planning and execution - Strong negotiation and vendor management skills - Proficient in event management software and online registration platforms - Knowledge of best practices in meeting planning, event design, and industry trends - Work comfortably in a fast-paced environment - Strong, effective time management skills - Flexibility to work with changing priorities and processes - Strong computer and software skills - Able to operate independently and with the team - Work flexible hours including evenings and weekends as required by event schedules - Occasional travel required (up to 10%) Education - Bachelor’s degree in event management, hospitality, business administration or related field preferred Benefits - Fully remote work - Flexible schedules - Generous vacation policy - Affordable health coverage - Stock options - Annual bonus