Director, Drug Product

Director, Drug Product – Strategic Leadership for Small Molecule Drug Development

We are seeking a visionary Director, Drug Product to lead the technical and operational excellence of small molecule drug product development in a fully remote capacity, based in Saudi Arabia. This senior leadership role offers the opportunity to shape and drive the entire development lifecycle—from formulation and manufacturing to scale-up, validation, and lifecycle management—while fostering collaboration across global teams and external partners. As the subject matter expert in drug product development, you will deliver high-impact technical direction, ensuring the reliable supply of clinical and commercial-grade products while navigating a dynamic, outsourced biotechnology environment.

In this pivotal role, you will combine deep scientific expertise with strategic foresight to advance multiple programs through every stage of development. Your influence will extend across formulation science, process optimization, regulatory compliance, and risk mitigation, ensuring seamless transitions from early-stage clinical trials to commercialization. This position demands a leader who can balance technical precision with operational agility, driving innovation while maintaining unwavering standards for quality, safety, and supply continuity.

Key Responsibilities

Your strategic leadership will be instrumental in the following critical areas:

• End-to-End Drug Product Strategy: Oversee the formulation, manufacturing, and lifecycle management of small molecule drug products, aligning technical strategies with clinical, regulatory, and commercial objectives from early development through commercialization.
• Formulation and Process Development: Direct the development of oral solid dosage forms, including formulation selection, optimization, and manufacturing process design, while ensuring scalable and robust control strategies for consistent product quality.
• Technology Transfer and Validation: Provide technical leadership for technology transfers, process characterization, and validation activities, ensuring seamless transitions between development and manufacturing sites while maintaining compliance with global regulatory standards.
• External Partner Management: Select, onboard, and oversee Contract Development and Manufacturing Organizations (CDMOs) and external partners, establishing clear expectations, timelines, and performance metrics to drive accountability for quality, delivery, and regulatory compliance.
• GMP Manufacturing Oversight: Monitor GMP manufacturing campaigns, including batch documentation, performance analytics, deviations, investigations, change controls, and Corrective and Preventive Actions (CAPAs), to mitigate risks and ensure regulatory adherence.
• Data-Driven Decision Making: Analyze formulation, manufacturing, analytical, and stability data to identify trends, troubleshoot challenges, and guide technical decisions that enhance product performance and regulatory readiness.
• Cross-Functional Collaboration: Partner closely with Analytical Development, Quality, Regulatory, Clinical Supply, and program teams to align development strategies, manufacturing plans, and supply chain logistics, ensuring seamless execution across all phases.
• Regulatory and Documentation Leadership: Author and review drug product sections of regulatory submissions, technical reports, development plans, specifications, and risk assessments, ensuring full compliance with FDA, EMA, ICH, and cGMP guidelines while supporting interactions with health authorities.
• Strategic Planning and Risk Management: Maintain comprehensive program plans, budgets, timelines, and risk assessments, proactively communicating challenges and recommending mitigation strategies to senior leadership and cross-functional teams.
• Technical Due Diligence and Innovation: Contribute to broader CMC strategy, product assessments, and continuous improvement initiatives, staying abreast of advancements in small molecule technologies, manufacturing approaches, and industry best practices to drive patient-centric solutions.

This role is ideal for a seasoned professional who thrives in a fast-paced, collaborative environment and is committed to advancing pharmaceutical innovation with integrity and excellence. Your strategic vision and technical expertise will be instrumental in shaping the future of drug development, ensuring that every product meets the highest standards of quality, safety, and regulatory compliance.