Director/Senior Director - CRO Solutions & Product Strategy

Director/Senior Director - CRO Solutions & Product Strategy

• Company: Saama
• Function: Product / Solutions
• Level: Director or Senior Director
• Location: Europe remote

Role Overview

Saama is seeking an experienced clinical research and CRO leader to help shape the next generation of AI-powered solutions for Contract Research Organizations (CROs).

This individual will serve as the vital bridge between Saama''s Product organization and our CRO customers and prospects. The ideal candidate has spent significant time inside a CRO and understands, at a practical level, how clinical trials are delivered—from study startup and clinical operations through data management, medical review, biometrics, and database lock.

This is not primarily a sales role and not primarily a traditional product-management role. It is a domain leadership role sitting directly at the intersection of: CRO Operations + Clinical Data + Product + AI + Customer Solutions

Key Responsibilities

1. Bring the CRO Perspective into Product

• Internal CRO SME: Serve as the internal CRO subject-matter expert for Saama''s Product and Engineering teams.
• Guide Core Execution: Help the team understand how CROs actually execute clinical studies, including:

o   Clinical data management, review, and cleaning

o   Query management & medical data review

o   Safety and external data reconciliation

o   Central monitoring and risk-based quality management (RBQM)

o   Biometrics, statistical workflows, and clinical operations

o   Study/site performance, database lock, data standards, and submission readiness

• Map Workflows: Map current CRO workflows and identify where AI, automation, and analytics can materially improve them.
• Define Requirements: Translate CRO operational pain points into clear product requirements and scalable use cases.

2. Shape CRO-Specific Product Capabilities

• Cross-Functional Partnership: Partner closely with Product Management, Engineering, and AI/Data Science to identify and prioritize required capabilities.
• Address Key Operational Questions: Help answer manual workload questions, FTE deployment bottlenecks, pre-database lock hurdles, and productivity vs. quality/compliance trade-offs.
• Build for Scale: Ensure capabilities are configurable across multiple sponsors rather than customized study-by-study, developing repeatable CRO products.

3. Lead CRO Customer & Prospect Discussions

• Customer Collaboration: Join commercial and solutions teams in direct conversations with CRO prospects and customers.
• Peer-Level Credibility: Act as a credible peer to stakeholders across Clinical Data Management, Clinical Operations, Biometrics, Medical Review, Central Monitoring/RBQM, Data Sciences, Tech, Operational Excellence, and Innovation.
• Lead Discovery: Lead discovery conversations to understand processes, tech environments, and business requirements, feeding insights back to Product.

4. Develop CRO Use Cases & Solutions

Identify and build high-value CRO use cases for Saama’s AI and clinical data capabilities, including:

• Intelligent Clinical Data Review: Automating identification, prioritization, and investigation of clinical-data issues.
• Automated Data Reconciliation: Reducing manual effort for lab, safety, imaging, eCOA, and external data.
• AI-Assisted Medical Review: Assisting medical reviewers in identifying clinically meaningful signals and anomalies.
• Database Lock Acceleration: Automating activities that delay clean database delivery.
• Risk-Based Quality Management: Utilizing analytics to flag sites, patients, and processes requiring attention.
• Clinical Operations Intelligence: Enhancing visibility into enrollment, site performance, and study execution.
• GenAI Workflows: Utilizing generative AI to reduce manual labor across trial delivery with proper human oversight.

5. Quantify CRO Business Value

• Shift the conversation from general AI capabilities to measurable operational impact for the CRO.
• Develop value models centered around FTE productivity, query/manual review reduction, faster data cleaning, accelerated DB lock, improved study quality, reduced rework, and improved CRO gross margins.
• Work directly with customers to establish baseline metrics and quantify potential ROI.

6. Support CRO Pilots & Early Adopters

• Partner with CRO customers during pilots and initial deployments to define use cases, current-state workflows, success metrics, user personas, product requirements, and adoption criteria.
• Capture lessons from early deployments to directly influence the broader Saama product roadmap.

Candidate Profile & Qualifications

Requirements

• Experience: ~12–18 years of clinical research experience, with substantial time spent working inside a CRO.
• CRO Tenure: 7+ years at major CRO organizations (e.g., IQVIA, ICON, Parexel, PPD/Thermo Fisher, Fortrea, Syneos Health, or similar).
• Relevant Titles: Currently or previously holding titles such as Director / Senior Director in Clinical Data Management, Data Sciences, Biometrics, Clinical Technology, Clinical Operations, Operational Excellence, Digital Transformation, Innovation, or Solutions Consulting.

Preferred Background & Knowledge

• Core Foundation: Strong Clinical Data Management / Data Sciences foundation paired with broad clinical trial operational knowledge.
• Operational Expertise: Deep understanding of how CROs deliver studies for pharma sponsors, EDC workflows, data review/cleaning, external data reconciliation, medical review, DB lock, staffing/FTE models, sponsor/CRO operating models, and regulatory/GxP considerations.
• Technology Platforms: Experience with systems such as Medidata Rave, Veeva Clinical Suite, Oracle Clinical/InForm, and related clinical technologies.
• AI/Innovation: Exposure to AI/ML, advanced analytics, automation, or GenAI within clinical development.

Critical Competencies

• Deep CRO Domain Expertise: Grounded understanding of how studies are delivered and where operational pain exists.
• Product Thinking: Ability to convert customer pain points into scalable, repeatable product capabilities.
• Customer Credibility: Capability to independently lead discovery sessions with senior CRO functional leaders.
• Commercial Awareness: Clear understanding of how technology creates measurable economic value and gross margin impact.
• AI Curiosity: Solid understanding of both the potential and limitations of AI within regulated GxP workflows.
• Communication: Ability to translate effectively between CRO operators, product managers, engineers, data scientists, and executives.

What Makes You Stand Out

The Ideal Profile: A former CRO operator who understands clinical data and trial delivery deeply, thinks like a product person, and can talk credibly to customers.

You are comfortable shifting gears seamlessly spending your morning with Saama Product and Engineering defining workflow mechanics ("How should this workflow actually work?") and spending your afternoon with a CRO Senior VP discussing strategic value ("Here''s how this could change your operating model"). You understand daily CRO friction, revenue drivers, and how AI can ensure Saama builds what CROs will actually buy and use.

Measures of Success (First 12–18 Months)

• Establish a clear map of priority CRO workflows and pain points.
• Define Saama''s highest-value CRO product use cases.
• Directly influence the Saama product roadmap based on CRO requirements.
• Support multiple CRO prospect and customer engagements, converting discovery discussions into pilots.
• Establish measurable ROI for Saama''s CRO solutions.
• Help convert successful pilots into repeatable products and referenceable CRO customer use cases.