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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

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.

The salary range for this position is: $255,425.00 - $330,550.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.