Gilead Sciences, Inc.
Senior Director, PDM Product Strategy Leader
Gilead Sciences, Inc., Foster City, California, United States, 94420
Senior Director, PDM Product Strategy Leader
United States - California - Foster City Process/Product Development & Operations
Regular Job Description
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. KEY RESPONSIBILITIES Reporting to the VP of PDM Product Strategy, within the Product and Portfolio Strategy (PPS) function, and part of the broader Pharmaceutical Development and Manufacturing (PDM) organization, this role leads strategic cross-functional teams responsible for all technical and CMC aspects of the assigned products, from entry into the technical development portfolio all the way through to the end of the product life-cycle. The PDM Product Leaders will be a team of people from diverse technical or business backgrounds. For some products, these leaders may be performing the role on a part-time basis, but this role is full-time and may be managing more than one product depending on the life-cycle related workload. FOCUS AREAS The successful candidate will: As the PDM representative on the Gilead Program Strategy Team, translate business strategy and PST vision into the PDM plan for execution, bring technical issues to the team and influence decision making and strategy. Proactively raise issues and options to the strategy teams and ensure consistent application of enterprise-wide prioritization principles. Ensure that technical perspectives and concerns are reflected in the strategic plans for the assigned products. Direct Process Development and Analytical Development teams to ensure effective and timely progression of pipeline projects and CMC life-cycle planning. Develop and own the product technical plan including timelines, multi-year budgets and critical deliverables, and influence PDM functional leaders, to ensure PDM meets the enterprise goals for the product. Develop and ensure delivery of the process and analytical development activity in alignment with products’ core strategy and milestones from the Technical Development Teams. Ensure end-to-end design, execution and risk mitigation activities across Process, Formulation and Analytical work packages from FIH through commercialization. Identify process, analytical development, and control system risks – then develop mitigation plans and enable effective and timely decisions through collaboration with Technical Development Teams and PDM partners. Prepare annual revisions to the technical strategic plans for the products. Take relevant decisions to direct the product team or, for decisions outside the teams’ scope, escalate and steer through the appropriate PDM governance mechanisms. Accountable for clear and timely communication to senior leadership on product activities throughout the enterprise against deliverables, timelines, and resources. Support other PDM Product Leaders in building a peer-group community with a range of technical backgrounds and experience through ongoing strategic coaching and skill development. Coach early in-career development scientists and engineers, and others working on the product team. REQUIREMENTS A degree in science, engineering, or technical field with directly relevant professional experience of at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, PharmD, or MD. Demonstration of outcome-oriented team leadership in some aspects of pharmaceutical manufacturing, or supply chain, or quality, or CMC regulatory, or process development, or as part of a cross-functional product team in the broader pharmaceutical industry. PREFERRED EXPERIENCE / SKILLS Strong influencing skills to effectively lead in a highly matrixed environment with minimal positional authority within the enterprise product teams and across PDM. Cross-functional and enterprise-wide relationship building skills. A strong business process orientation but able to deploy processes practically and with the maximum impact. Knowledgeable in cGMP manufacturing and regulatory regulations and requirements for biologics and/or small molecules. Ability to work in a dynamic environment with multiple products and modalities. Strength in coaching and mentoring scientists and engineers across functional areas. Strong interpersonal, verbal, and written communication skills with the ability to synthesize complex situations, illustrate conceptual paths, and facilitate discussions leading to resolution on key issues. Ability to work efficiently and independently in a changing environment. Comfort with assuming responsibility and accountability for taking impactful decisions. Strong business and strategic skills – for example, converting the high-level goals for a product into a coherent plan for prioritized activities within PDM to support and deliver against those goals. Gilead Core Values Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce.
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United States - California - Foster City Process/Product Development & Operations
Regular Job Description
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. KEY RESPONSIBILITIES Reporting to the VP of PDM Product Strategy, within the Product and Portfolio Strategy (PPS) function, and part of the broader Pharmaceutical Development and Manufacturing (PDM) organization, this role leads strategic cross-functional teams responsible for all technical and CMC aspects of the assigned products, from entry into the technical development portfolio all the way through to the end of the product life-cycle. The PDM Product Leaders will be a team of people from diverse technical or business backgrounds. For some products, these leaders may be performing the role on a part-time basis, but this role is full-time and may be managing more than one product depending on the life-cycle related workload. FOCUS AREAS The successful candidate will: As the PDM representative on the Gilead Program Strategy Team, translate business strategy and PST vision into the PDM plan for execution, bring technical issues to the team and influence decision making and strategy. Proactively raise issues and options to the strategy teams and ensure consistent application of enterprise-wide prioritization principles. Ensure that technical perspectives and concerns are reflected in the strategic plans for the assigned products. Direct Process Development and Analytical Development teams to ensure effective and timely progression of pipeline projects and CMC life-cycle planning. Develop and own the product technical plan including timelines, multi-year budgets and critical deliverables, and influence PDM functional leaders, to ensure PDM meets the enterprise goals for the product. Develop and ensure delivery of the process and analytical development activity in alignment with products’ core strategy and milestones from the Technical Development Teams. Ensure end-to-end design, execution and risk mitigation activities across Process, Formulation and Analytical work packages from FIH through commercialization. Identify process, analytical development, and control system risks – then develop mitigation plans and enable effective and timely decisions through collaboration with Technical Development Teams and PDM partners. Prepare annual revisions to the technical strategic plans for the products. Take relevant decisions to direct the product team or, for decisions outside the teams’ scope, escalate and steer through the appropriate PDM governance mechanisms. Accountable for clear and timely communication to senior leadership on product activities throughout the enterprise against deliverables, timelines, and resources. Support other PDM Product Leaders in building a peer-group community with a range of technical backgrounds and experience through ongoing strategic coaching and skill development. Coach early in-career development scientists and engineers, and others working on the product team. REQUIREMENTS A degree in science, engineering, or technical field with directly relevant professional experience of at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, PharmD, or MD. Demonstration of outcome-oriented team leadership in some aspects of pharmaceutical manufacturing, or supply chain, or quality, or CMC regulatory, or process development, or as part of a cross-functional product team in the broader pharmaceutical industry. PREFERRED EXPERIENCE / SKILLS Strong influencing skills to effectively lead in a highly matrixed environment with minimal positional authority within the enterprise product teams and across PDM. Cross-functional and enterprise-wide relationship building skills. A strong business process orientation but able to deploy processes practically and with the maximum impact. Knowledgeable in cGMP manufacturing and regulatory regulations and requirements for biologics and/or small molecules. Ability to work in a dynamic environment with multiple products and modalities. Strength in coaching and mentoring scientists and engineers across functional areas. Strong interpersonal, verbal, and written communication skills with the ability to synthesize complex situations, illustrate conceptual paths, and facilitate discussions leading to resolution on key issues. Ability to work efficiently and independently in a changing environment. Comfort with assuming responsibility and accountability for taking impactful decisions. Strong business and strategic skills – for example, converting the high-level goals for a product into a coherent plan for prioritized activities within PDM to support and deliver against those goals. Gilead Core Values Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce.
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