Director, Product Mgmt, Data Science

Key Responsibilities:

Product Strategy & Roadmap

• Define drive development and execute implementation for product strategy for complex AI-driven regulatory tools that accelerate submissions optimize document lifecycle management and ensure regulatory compliance

• Develop and maintain detailed product roadmaps that align with global regulatory business objectives data science goals and emerging AI technologies

• Collaborate with data science teams to translate human-centered workflows and decision-making processes into technical product requirements to support and enhance performance including building multi-agent systems to assist with complex regulated processes

• Drive prioritization decisions across competing initiatives and resource constraints for technology-enablement

• Identify and evaluate opportunities where generative AI can transform document generation QC review processes and virtual regulatory interactions

Stakeholder Management & Cross-Functional Leadership

• Collaborate closely with cross-functional teams to understand their needs and develop product strategies to support multiple use cases

• Support regulatory teams on their digital transformation journey with generative AI enabled technologies

• Work closely with data scientists AI engineers regulatory experts advanced modeling and data teams and design-thinking teams in an agile matrixed environment

• Distinguish critical priorities from distractions in complex product development environments consistently driving the team toward measurable progress on key business outcomes

• Facilitate alignment between business stakeholders and technical teams on product vision and delivery

• Present product updates and strategic recommendations to senior Data Science Global Regulatory Affairs and other R&D leadership ensuring multi-level alignment

Product Development & Delivery

In conjunction with other Product Development team members:

• Lead agile delivery product teams with end-to-end product lifecycle from concept through launch and iteration

• Define user stories acceptance criteria and success metrics for regulatory workflow tools

• Coordinate with other data science teams to enable the technical execution deployment and life cycle maintenance for AI tools to support regulatory workflows

• Coordinate cross-functional sprints and manage product backlogs

• Ensure products meet data integrity regulatory compliance and validation requirements

Regulatory Technology Enablement

• Understand and leverage emerging generative AI technologies to support submission acceleration and regulatory strategy

• Design and implement AI-enabled frameworks that streamline regulatory document workflows and health authority query response generation

• Work together with the regulatory data hub to create and utilize AI-ready data packages for downstream tools and applications

• Champion the adoption of new technologies among global regulatory teams providing training and change management support to drive productivity and regulatory excellence

Required Qualifications:

• Education: Advanced degree (MS/PhD) or equivalent practical experience in Life Sciences Regulatory Affairs Data Science or related field

• Experience: 10 years in product management activities with 3-5 years of experience leading teams with 5 years of hands-on product management experience and with 3 years in pharmaceutical/biotech clinical development environment

• Regulatory expertise: Strong understanding of global regulatory submission processes (e.g. FDA EMA PMDA) and compliance requirements

• Technical Skills: Experience with developing or deploying generative AI tools and skills including prompt engineering RAG development knowledge graphs agent-based approaches in the context of document generation and domain-specific reasoning

• Product Management: Proven track record using agile methodologies product analytics and user-centered design principles. Ability to translate complex regulatory requirements into actionable technical specifications

Preferred Qualifications:

• Cross-functional Product Design: Experience in leading development of complex multi-agent genAI-based tools with familiarity on the full genAI tech stack

• Regulatory Technology & Digital Transformation Experience: 3 years experience with regulatory data management systems e-submission platforms and document interchange standards

• Generative AI Background in Pharma: Familiarity with generative AI platforms and their application in regulatory settings including natural language processing (NLP) and automated quality control tools

• Experience with cloud platforms and clinical data lakes/warehouses

Key Competencies

Technical Acumen

• Possesses a deep understanding of generative AI technologies and actively engages with technical teams to provide actionable feedback throughout the product development lifecycle.

• Bridges the gap between business needs and technical execution ensuring that product features and enhancements are both innovative and practical

• Translate complex clinical and regulatory requirements into technical specifications

• Understand data science methodologies and their applications to clinical decision-making

• Navigate pharmaceutical technology landscape and emerging digital health solutions

Strategic Thinking

• Balance short-term delivery needs with long-term R&D strategic objectives

• Identify opportunities for workflow optimization and competitive advantage

• Assess market trends and incorporate innovative approaches into product strategy

Communication & Influence

• Excellent written and verbal communication skills for diverse audiences from lab scientists to C-suite executives

• Ability to influence without authority in highly matrixed organizations

• Strong presentation skills for regulatory submissions and board-level updates

Problem-Solving & Analytics

• Data-driven decision making with strong analytical and critical thinking skills

• Ability to synthesize complex clinical and operational data into actionable insights

• Experience with A/B testing and product experimentation in regulated environments

What We Offer JOINING THE R&D - DSDH TEAM

• Opportunity to directly impact patient outcomes through innovative clinical trial technologies

• Collaborative environment with world-class data scientists and clinical experts

• Exposure to cutting-edge pharmaceutical R&D processes and regulatory landscapes

• Competitive compensation package with equity participation

• Professional development opportunities and conference attendance

Location and Travel

• Occasional travel (15-20%) for cross-functional face-to-face work sessions site visits and industry conferences