Executive Director, Combination Product Development

Descripción del trabajo

Executive Director, Combination Product Development

Overview

The Executive Director of Combination Product Development drives the end-to-end technical strategy for combination product development, guiding programs from early concept through global commercialization. Reporting to the Vice President of Device, Packaging and Process Development, this leader leverages technical expertise and execution with regulatory acumen to ensure Gilead delivers safe, robust, and effective combination products to the market. Success in this role requires fluency in a matrixed environment, working seamlessly with external development partners, mastery of stakeholder alignment, and a relentless focus on technical rigor coupled to appropriate quality and compliance standards.

Key Responsibilities

• Develop and execute the global combination product development strategy, ensuring clear linkage to corporate objectives, therapeutic priorities, and market demands.

• Cultivate and manage strategic relationships with external development partners—including CMOs, CDMOs, academic institutions, and technology licensors—to accelerate technical innovation, ensure alignment with technical and regulatory standards, and optimize resource utilization across the combination product portfolio. This includes driving joint development agreements, technology transfers, and co-investment opportunities that enhance Gilead’s competitive edge in combination product delivery.

• Lead and align multidisciplinary teams within the G. Ecosystem—including engineering, formulation, clinical, regulatory, quality, manufacturing, supply chain, and marketing—to achieve milestones on time, on budget, and within predefined risk thresholds. This also includes an on-going alignment with key PDM stakeholders, e.g. PDM Leads and PDM sub team leads

• Oversee the design, development, and integration of drug–device systems, facilitating and managing CMC (Chemistry, Manufacturing, and Controls) programs from initial feasibility through full-scale commercialization.

• Partner with global regulatory (clinical and CMC) for developing combination products and maintaining compliance with evolving requirements across FDA, EMA, PMDA, and other global authorities.

• In concert with CMC RA and other key PDM functions, oversee preparation, review, and approval of all regulatory submissions (e.g., INDs, NDAs, PMAs, 510(k)s, MAAs), including CMC sections, and manage lifecycle maintenance activities and post-market surveillance.

• Serve as the primary combination product technical interface with health authorities, fostering transparent, proactive agency interactions and championing novel development pathways such as expedited review and real-world evidence.

• Provide strategic oversight for late-stage development and commercialization readiness, ensuring robust risk-based decision-making and alignment with global launch timelines.

• Establish and monitor key performance indicators (KPIs) for combination product programs—such as submission timelines, approval cycle times, inspection findings, and post-market metrics—reporting progress to senior leadership.

• As a DPP LT member and individual contributor, assist individuals and teams in fostering a culture of inclusion, continuous learning, accountability, technical rigor, and talent retention.

• Establish a forward-looking technical capability roadmap for DPP, identifying emerging technologies, skill gaps, and infrastructure needs. Champion internal technical capability building through targeted training programs, cross-functional knowledge sharing, and investment in advanced modeling, simulation, and prototyping tools. Ensure the team remains at the forefront of device-drug integration, human factors engineering, and regulatory science.

Required Qualifications

Qualification Details

Education: Advanced degree (PhD, PharmD, Engineering) in biomedical engineering, pharmaceutical science, or related field

Experience: 16+ years of experience with a BA/BS and 14+ years with an advanced degree.

Regulatory Expertise: Direct experience with global regulatory submissions and agency interactions for combination products

Project & Portfolio Management: Demonstrated ability to manage complex, high-value portfolios within stage-gate frameworks

Quality & Compliance: In-depth knowledge of QSR, ISO 13485, EU MDR/IVDR, and GxP standards

Preferred Experience

• Successfully commercialized combination products across multiple therapeutic areas.

• Familiarity with biologics development and upstream/downstream bioprocessing workflows.

• History of strategic partnerships with CMOs/CDMOs, academic institutions, and technology licensors.

Core Competencies

• Strategic Thinking: Anticipate market trends, shape roadmaps, and pivot strategies proactively.

• Leadership & Influence: Build consensus across global, cross-disciplinary teams and external partners.

• Technical Acumen: Deep understanding of device engineering, drug formulation, integration challenges, and CMC considerations.

• Risk Management: Apply proactive risk assessments and mitigation plans to safeguard patient safety and product quality.

• Communication: Translate complex technical and regulatory concepts into clear, compelling messages for executive leadership, regulatory agencies, and external collaborators.