Gilead Sciences Inc

Assoc Director, Business Strategy and Operations

Gilead Sciences Inc • $158K — $204K *
Mississauga, ON L4T 0A1In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BA/BS in Life Sciences, Engineering or related field preferred, with 10+ years of relevant industry experience or 8+ years with advanced degrees.
  • Experience in regulatory operations, particularly within CMC Regulatory Affairs or similar regulated environments.
  • Proven track record in business process design, mapping, optimization, and operational improvement initiatives.
  • Ability to convert business needs into clear requirements and collaborate with technology teams for digital solutions.
  • Experience leading cross-functional projects in a globally matrixed organization.
  • Strong grasp of pharmaceutical regulatory processes and lifecycle, particularly with CMC regulations.
  • Familiarity with regulatory information management, workflow, analytics, automation, or AI solutions.

Responsibilities

  • Lead mapping, analysis, and optimization of business processes in CMC Regulatory Affairs.
  • Identify and address operational inefficiencies and propose improvements through collaboration.
  • Employ structured problem-solving to develop sustainable solutions.
  • Conduct workshops to define processes and establish implementation strategies.
  • Support the creation and maintenance of governance mechanisms for consistent execution.
  • Develop KPIs to measure process performance and drive improvements.
  • Assist in operational and resource planning using enterprise forecasting tools.

Benefits

  • Collaborative work environment encouraging cross-functional engagement.
  • Opportunities for continuous professional development in regulatory operations.
  • Access to enterprise tools and platforms enhancing process efficiency.
  • Participation in digital transformation initiatives, including AI and automation.
  • Involvement in shaping regulatory processes aligned with global requirements.
Full Job Description
Job Description

Key Responsibilities

Regulatory Operations & Process Improvement
  • Lead business process mapping, analysis, design, and optimization initiatives across CMC Regulatory Affairs, including development, registration, post-approval, and lifecycle management activities.
  • Identify operational pain points, process gaps, inefficiencies, and opportunities for simplification or digital enablement in partnership with process owners and subject matter experts.
  • Apply structured problem-solving and data-driven approaches to evaluate root causes, assess options, and develop practical and sustainable solutions.
  • Facilitate cross-functional workshops and working sessions to define current and future-state processes, clarify roles and decision points, and establish implementation plans.
  • Support the development and maintenance of process standards, procedures, governance mechanisms, and operational controls that enable consistent execution across CMC Regulatory Affairs.
  • Develop and monitor operational measures and KPIs to evaluate process performance, adoption, and opportunities for continued improvement
  • Support portfolio, resource, and operational planning activities as needed, including use of enterprise planning and resource forecasting tools.


Digital Enablement, Data & Systems
  • Partner with the CMC Digital Enablement Head, business process owners, IT, and other stakeholders to identify and advance digital opportunities that address meaningful regulatory business needs.
  • Translate regulatory operational needs and process requirements into clear business requirements and use cases for digital, automation, data, and technology solutions.
  • Lead or support the implementation of digital solutions from business problem definition and requirements development through testing, deployment, adoption, and continuous improvement.
  • Establish and monitor success metrics for digital and AI-enabled capabilities including adoption, operational efficiency, quality, user experience, and business value realization.
  • Evaluate opportunities to apply workflow automation, analytics, artificial intelligence, and emerging technologies to improve regulatory processes and decision-making.
  • Support integration of regulatory processes, data, content, and systems to enable more connected and efficient ways of working.
  • Partner with data and system owners to improve data quality, usability, and availability for regulatory operations, analytics, and decision-making.
  • Develop dashboards, metrics, and operational insights that increase visibility into performance and enable data-driven decisions.
  • Support user acceptance testing, implementation readiness, change management, and adoption of new or enhanced digital capabilities.


Cross-Functional Delivery & Change Leadership
  • Lead complex cross-functional initiatives involving CMC Regulatory Affairs, Regulatory Affairs, Technical Development, Quality, Manufacturing, Supply Chain, Strategy & Operations, IT, and other relevant stakeholders.
  • Establish clear project objectives, scope, deliverables, roles, dependencies, and implementation plans for assigned initiatives.
  • Build alignment among stakeholders with differing priorities and translate complex operational or technical topics into clear business decisions and actions.
  • Develop recommendations and decision materials for CMC Regulatory Affairs leadership based on analysis of operational challenges, opportunities, risks, and potential solutions.
  • Partner with Regulatory Policy, Intelligence, and Health Authority Strategy colleagues to ensure processes and solutions remain aligned with evolving global regulatory requirements and expectations.
  • Drive organizational change initiatives to successfully implement new processes, digital tools, and AI-enabled ways of working, including stakeholder engagement, communications, training, adoption strategies and measurement of expected outcomes.
  • Promote effective process management and digital ways of working across CMC Regulatory Affairs by sharing tools, methodologies, lessons learned, and scalable approaches.


Qualifications
  • BA/BS in Life Sciences, Engineering or related field preferred with relevant industry experience 10+ years with BS/BA; 8+ years with MS/MA/MBA
  • Experience in regulatory operations, CMC Regulatory Affairs, pharmaceutical development, or a related regulated environment.
  • Demonstrated experience leading business process design, mapping, optimization, or operational improvement initiatives.
  • Experience translating business needs into requirements and partnering with technology teams to implement digital or system-enabled solutions.
  • Experience leading complex, cross-functional initiatives in a global and highly matrixed organization.
  • Strong understanding of pharmaceutical regulatory processes and the regulatory lifecycle; experience with CMC regulatory processes strongly preferred.
  • Familiarity with regulatory information management, document/content management, workflow, data, analytics, automation, or AI-enabled solutions.
  • Experience with relevant enterprise platforms and tools such as Veeva Vault, Planisware, Signavio, Visio, Power BI, or similar technologies is desirable.
  • Demonstrated ability to analyze complex problems, structure ambiguous issues, develop recommendations, and drive work through implementation.
  • Strong facilitation skills with demonstrated ability to gather subject matter expert input and translate it into clear, practical end-to-end processes and requirements.
  • Strong communication and influencing skills with the ability to work effectively across functions and organizational levels.
  • Lean, Lean Six Sigma, or other process improvement training or certification is desirable; demonstrated practical application of process improvement methodologies is more important than certification alone.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

The salary range for this position is CAD $158,355 - $204,930 annually. In addition, this role is eligible for a discretionary target annual bonus. Gilead determines base compensation by considering factors such as experience, qualifications, and geographic location. As a result, actual compensation may vary.

AI Clause

We use AI-enabled tools to support our recruitment process. All hiring decisions are made by our recruitment team.

About Gilead Sciences Inc

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, they seek to improve the care of patients suffering from life-threatening diseases. Gilead's primary areas of focus include HIV/AIDS, liver disease, and serious cardiovascular and respiratory conditions.

Gilead Sciences Inc Careers

Join the vibrant team at Gilead Sciences Inc, a leader in the biopharmaceutical industry known for its innovative approach to healthcare. At Gilead, we are committed to advancing the care of patients around the globe through rigorous science and research.

Work You’ll Do

Embark on a career journey with Gilead Sciences Inc, where job opportunities abound in a variety of fields, from scientific research to marketing and sales. Our team is dedicated to fostering an environment of diversity and inclusion, where every employee can thrive.

Innovate and Lead

At Gilead, innovation is at the core of everything we do. Join us and contribute to our mission of saving lives through advanced treatments and cutting-edge medicine. Our leadership is committed to nurturing professional growth, making Gilead an ideal place for those who aim to lead and innovate in the healthcare industry.

Grow Your Career

Gilead Sciences Inc offers a wealth of career advancement opportunities. With personalized career development programs, employees are encouraged to pursue their professional interests and expand their skills. Whether through on-the-job learning, formal training, or leadership development, we provide the tools necessary for long-term career growth.

Be Part of Our Team

Our team at Gilead Sciences Inc is composed of passionate, curious, and solution-driven professionals. By joining us, you’ll collaborate with some of the brightest minds in the industry. Our culture promotes teamwork and an interdisciplinary approach to problem-solving, making our workplace dynamic and innovative.

Internship and Employment Opportunities

Start your career with Gilead through our internship programs, which offer hands-on experience in biopharmaceutical development and business operations. For seasoned professionals, our employment opportunities span across various disciplines, inviting you to bring your valuable skills to our team.

Benefits and Culture

Gilead Sciences Inc is not only a great place to work but also offers competitive benefits designed to support the health, well-being, and financial security of our employees and their families. From health insurance to retirement plans and wellness programs, we ensure our team members are taken care of.

Networking and Professional Development

We emphasize the importance of networking and professional development within the company. Regular workshops, seminars, and training sessions are held to enhance your skills and knowledge. Additionally, Gilead’s strong emphasis on internal networking allows for cross-departmental collaboration and innovation.

Join Our Hiring Events

Stay connected with Gilead by joining our hiring events and exploring open positions that match your skills and interests. We are always on the lookout for dedicated, creative, and driven team players. Prepare your resume, ace the interview, and take the first step towards a fulfilling career at Gilead Sciences Inc.

Explore Jobs at Gilead Sciences Inc

Discover the exciting career opportunities waiting for you at Gilead Sciences Inc. Visit our careers page to search for open positions, read about our company culture, and learn how you can make a difference in the global healthcare landscape.

Stay Up to Date

Keep informed with the latest company news, career tips, and industry insights—all from the people who work at Gilead Sciences Inc. Subscribe to our job alert emails and personalize your experience to receive updates that align with your career preferences. Join Gilead Sciences Inc today and be part of a team that values innovation, leadership, and a commitment to diversity and employee growth.
Learn more about Gilead Sciences Inc
Size
14,400 employees
Market Cap
$107.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$123 million
Founded
1987
5 Year Trend
-2.1%
Revenue
$24.6 billion
NASDAQ
GILD
* Ladders Estimates

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