Перейти к основному содержимому
BeOne

Senior Director, Global Development Technology Solutions

УдалённоUnited States только
Опубликовано
Роль
Инженерный менеджмент
Опыт
Лид
$207.8k–$277.8k/yr
Проверьте доступность

Доступно для: US only. Укажите, откуда вы работаете, чтобы проверить доступность.

Коротко по делу

Senior R&D technology leader for pharma/biotech Clinical Development, with 12+ years in data/digital/IT and 7+ years senior leadership. Needs deep Clinical Development domain knowledge plus ML/AI/genAI, cloud/SaaS, software lifecycle, 21CFR Part 11, GxP CSV, and regulated pharma systems experience. Remote US role.

Ключевые навыки

AIGenerative AIClinical Development Systems

Обязательные навыки

MLCloudSaaS21CFR Part 11GxPCSVICHAgileScrumKanbanLean

Чем предстоит заниматься

  • Collaborate with the Clinical Development functions (Clinical Operations, Safety, Regulatory, Clinical Development, Pharmacology etc.) to understand their scientific strategy, priorities, and unmet digital/technology needs.
  • Define and own a multi-year Digital & Technology Roadmap for the Clinical Development organization within R&D, with a focus on externally / vendor developed solutions & systems, ensuring it directly enables key scientific milestones, accelerates discovery, and aligns with overall R&D strategy.
  • Translate complex scientific & technical needs into clear, documented, and prioritized data, digital & technology requirements and use cases.
  • Oversee the end-to-end process, from identification, assessment, onboarding, development / deployment, launch of technology systems & solutions specific to Development functions (Clinical Operations, Safety, Regulatory, Clinical Development, Pharmacology etc.).
  • Utilize subject matter expertise to advise and provide guidance to Development function & sub-function teams on ML/AI/genAI-related asks and needs for externally developed systems.
  • Lead end-to-end process assessments to identify, design and implement automation, optimization, embedded ML/AI/genAI, technology components & digital tools to enable digital transformation of Development-function processes.
  • Oversee the enforcement of rigorous data formatting, semantic consistency, and interoperability standards for all data ingested from external vendor systems, ensuring external data seamlessly maps to internal architectural requirements.
  • Partner actively with internal Data Management teams to align vendor system outputs with enterprise-wide master data management strategies, and core reference models.
  • Oversee data governance guardrails for third-party platforms, ensuring that external ecosystems handle internal datasets in strict adherence to data security, lineage tracing, and compliance mandates.
  • Lead change management programs for externally developed systems & platforms.
  • Manage the behavioral shift required for digital adoption & change management initiatives.
  • Scan the external landscape for novel digital & technology products, platforms & systems to inform the needs of the Development function.
  • Provide digital & Technology-related SME for the identification, evaluation, and management of technology vendors who provide cutting-edge scientific platforms, solutions, software etc. and / or AI/ML capabilities, as needed.
  • Lead, mentor, and manage a high-performing GRDTS team dedicated to the Development function.
  • Foster a culture of innovation, accountability and drive professional development.
  • Ensure all Development-related systems and platforms adhere to relevant pharmaceutical industry regulations and internal security policies.
  • Liaise with vendors, Enterprise IT partners, audit, and compliance to coordinate system implementation and change activities.
  • Ensure the team is trained in and embeds CSV, compliance, and health authority requirements into operational activities.
  • Manage the Development function’s technology portfolio budget to maximize return on investment.
  • Act as the voice of Development function within the broader GTS (Enterprise IT) organization, ensuring it’s needs are prioritized.
  • Collaborate with other teams on standards and best practices.
  • Engage with peers to define, sponsor, and execute continuous improvements.
  • Lead, mentor, and manage a high-performing GRDTS team dedicated to the Development function.
  • Develop a comprehensive, rolling 3-year strategic blueprint mapping technology solutions directly to scientific capability milestones.
  • Create visual matrices mapping out current-state vs. future-state technical capabilities across Development & its sub-functions.
  • Create detailed, prioritized functional and technical requirement backlogs that can be used by the Systems Engineering team to integrate or enhance platforms.
  • Prepare formal evaluations, technical scores, and business cases for onboarding specialized vendor platforms or niche scientific AI tools.
  • Co-author governance structures with the Systems Engineering capability & GTS to ensure development platforms remain stable, highly available, and optimized during production runs.
  • Define clear Key Performance Indicators (KPIs) linked to scientific delivery outcomes, alongside an actively managed competency framework to close technical and domain gaps within the team.
  • Create structured career pathways and talent retention strategies that cultivate high-performing team members into future R&D IT leaders.

Что требуется

  • A successful candidate is a dynamic leader who brings deep end-to-end pharma / biotech Clinical Development domain knowledge with technical expertise related to digital & technology systems, processes, data science, analytics, AI, & genAI.
  • Strong experience in cloud/SaaS environments, ability to manage multiple projects across different sub-functions in a global, geographically diverse environment, and building and sustaining teams in times of ambiguity are all critical success factors for this role.
  • An ideal candidate will adapt communication cadences and problem-solving skills to accommodate stakeholders, partners, and team members, exercise diplomacy and effective influence to reach consensus, and build strong relationships.
  • Strategic Roadmap Architecture: Translating long-term scientific objectives into a multi-year digital and technology capability roadmap.
  • Biomedical & Technical Translation: Fluency in "scientific domain speak" to accurately translate complex scientific workflows into structural, technical software and data requirements.
  • Stakeholder Orchestration & Influence: Navigating a matrixed environment to align disparate development functions, internal IT groups, and external vendors around unified platform standards.
  • Solution Lifecycle Oversight: Managing the end-to-end delivery of digital solutions for the development function—from initial scoping and vendor selection through deployment and value realization.
  • Technology Portfolio Management: Balancing disruptive horizontal technologies (e.g., Generative AI, RAG frameworks) with the stabilization of foundational development platforms.
  • Pharma Industry R&D Domain Literacy: A deep end-to-end understanding of the pharmaceutical research and development value chain.
  • AI & Data Literacy: Conceptual grasp of modern data science paradigms, including machine learning lifecycle, foundational models, and "AI-ready data" requirements.
  • Agile Product Mindset: Treating digital platforms as evolving products rather than static IT projects, focusing on iterative delivery and user-centric design.
  • Strategic Communication: The ability to simplify dense technical architectures for scientific leadership and articulate deep scientific constraints to engineering squads.
  • Transformational & People Leadership: Proven ability to recruit, mentor, and inspire a diverse, high-performing team members.
  • Skilled at fostering a culture of psychological safety, continuous learning, and cross-functional empathy between tech and science.
  • 12+ years of professional experience in data, digital & information technology with direct oversight and experience in / for the Clinical Development-related area in the Pharmaceutical, Biotechnology, and/or Medical Device industries
  • 7+ years of proven leadership experience at a senior level, directing a team of multi-skilled direct reports and associate-level team members.
  • 7+ years combined experience in design, deployment, & support of Clinical Development function focused digital transformation of processes, platforms, systems, software, repositories etc.
  • Strong experience in ML/AI/genAI methods and technologies to support the Clinical Development function.
  • Business relationship management acumen and demonstrable success as a change agent leading or contributing to significant transformational initiatives in organizations.
  • Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV), ICH guidelines.
  • Accomplished in building and development of people and teams, comfortable working with a broad cross section of people in direct and matrixed relationships
  • Proficient in various project management disciplines (i.e., Agile, Scrum, Kanban, Lean etc.)
  • Bachelor or above
  • Some travel expected as part of assigned duties
  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

Преимущества

  • Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan.
  • All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.
  • Medical
  • Dental
  • Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals focused on fighting cancer.

BiotechКрупнаяbeone.es/

Что говорят о компании

3.0/ 5

$207.8k–$277.8k/yr