Executive Director, Head of U.S. Medical Population Science & Health
Executive director job at Genentech
** **The Opportunity** The Head of US Medical Population Science & Health (USM PS&H) will lead the CMG US Medical Population Science & Health team reporting to the VP Head of US Medical. This role is part of the US Medical Leadership Team, alongside other senior leaders such as the VP, Head of Scientific Operations. This individual will manage a team of two Medical Science Health Population Directors, and one Field Medical Health Population Director , focused on advancing population science and health outcomes for all Genentech and Roche patients and aligned with specific therapy area initiatives. They will ensure long-term, sustainable above-brand PS&H strategies that support Roche's 2030 vision.
The Head of USM PS&H will collaborate with other USM teams and functional leads to ensure enterprise-wide strategic alignment, acting as a key medical spokesperson internally and externally with various committees, regulatory bodies, and industry forums. This individual will represent USM across the enterprise, engaging with executive teams from PD, gRED, pRED, and CMG, serving on the USLT and ecosystem leadership teams, and maintaining global alignment. . Externally, they will be the primary USMA PS&H contact for C-suite healthcare professionals, while their team will focus on engagements with the Field and Medical Network..
**Key Responsibilities**
Strategic Leadership & Vision
+ Build sustainable Population Science & Health (PS&H) strategies aligned with CMG and Roche 2030 visions, ensuring alignment with Squads and Medical teams. Integrate PS&H into USM strategy and field medical execution through playbooks, frameworks, and training.
+ Embed Population Science and Health across the Medical organization, leading strategy and efforts, and translating enterprise vision into cross-portfolio clinical and evidence generation plans. Lead interactions with regulatory agencies and experts, partnering with Squads to develop and communicate integrated PS&H strategies.
Operational & Financial Accountability
+ Responsible for budget management of PS&H activities in USMA, delivering Phase IIIb/IV studies, and strengthening Genentech's ability to execute clinical trials, especially for specific populations, to reduce trial delays or non-approvals.
+ Drives evidence generation and trial outcomes by providing U.S.-specific data for regulatory approvals, payer negotiations, and inclusive research standards, aiming for faster clinical trial enrollment and increased participation from underrepresented communities; may also serve as Medical Monitor back-up and embed best practices for broader patient representation in trials.
Cross-Enterprise Representation & Collaboration
+ Represent USMA PS&H internally, interfacing with executive leadership teams (PD, gRED, pRED, CMG), and externally, representing USMA PS&H at USM and PH CoE leadership meetings. Proactively guide Field Medical and USM engagement with underserved health systems and clinicians to expedite recruitment and successful completion of critical Phase IV trials. Lead across the One Roche Enterprise, engaging with C-Suite Executives from Foundation Medicine, Flatiron, and Roche Diagnostics.
Field Population Health Support Oversight
+ Provide strategic direction and guidance for the Medical Science Health Population Directors and Field Medical Health Population Director , ensuring alignment with national objectives and equitable health outcomes by strengthening partnerships with underserved health systems, community providers, and ecosystem stakeholders, and equipping field medical teams to communicate PS&H value, build trust, strengthen trial site relationships, and support patient enrollment, while also ensuring consistent bi-directional knowledge flow between field team insights and internal strategy to optimize PS&H impact and responsiveness.
Compliance, Risk & Governance
+ Ensure the PSH team follows compliance governance practices and processes relevant to collaborative work (e.g., confidentiality, intellectual property, data privacy, interactions with customers, pharmacovigilance) and proactively manage risk in external collaborations and evidence generation, ensuring alignment with Roche standards, legal frameworks, and evolving global regulatory expectations.
External Partnerships & Community Impact
+ Lead strategic partnerships and serve as a senior medical spokesperson to advance population science and health. This includes collaborating with national payers and healthcare institutions to improve access to Roche medicines for underserved patients, promoting PS&H's vision with KOLs, regulators, and executives, and enhancing Genentech's reputation in population health to strengthen external partnerships.
+ Drive initiatives to educate underserved communities. Partner with the Population Health CoE on novel internal or external initiatives to address knowledge and trust gaps among providers, investigators, and patients in underserved communities.
Team Culture & Organizational Influence
+ Champion a high-performing environment within the PS&H team that fosters accountability, innovation, and collaborative ways of working across functions, while also co-creating an inspiring team culture by consistently living the Genentech Operating Principles and fostering an environment of respect and collaboration.
**Who you are**
**Qualifications & Experience**
+ Advanced degree (MD, PhD, PharmD) in MPH or other relevant field.
+ 15+ years of pharmaceutical or biotechnology industry experience, or 10+ years, including at least 5 years in Medical Affairs or Clinical Development leadership roles.
+ Deep expertise in population health, real-world data, and upstream interventions.
+ Track record of strategic influence, organizational change leadership, and enterprise collaboration, including engaging senior external stakeholders and representing organizations at national forums.
+ Demonstrated experience supervising and developing high-performing teams, including in-house and field-based medical professionals.
+ Significant experience operating effectively and delivering results with a strong focus on compliance and integrity, along with an understanding of Phase I-III and/or Phase IV drug development.
**Preferred Qualifications & Experience**
+ MPH or other population health-related training.
+ Possess a sophisticated understanding of the evolving global and US regulatory, medical practice, and economic environments impacting Roche/Genentech, coupled with thorough knowledge of US regulatory/FDA requirements.
+ Scientific credibility and enterprise thinking on how Medical Affairs impacts the broader organization, with ability to provide proactive solutions to complex needs.
+ Understanding of legal and regulatory considerations impacting the pharma/biotech industry, and ability to apply these principles effectively to daily activities.
**Travel Requirements**
The position is located in South San Francisco. The position may require up to 25% time traveling.
The expected salary range for this position based on the primary location of South San Francisco, CA is $269,700 - 500,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits (****************************************************
Relocation benefits are not available for this job posting.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
Executive Director, Computational Biology - Oncology
Executive director job at Genentech
** A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.
Advances in AI, data, and computational sciences are transforming drug discovery and development. Roche's Research and Early Development organisations at Genentech (gRED) and Pharma (pRED) have demonstrated how these technologies accelerate R&D, leveraging data and novel computational models to drive impact. Seamless data sharing and access to models across gRED and pRED are essential to maximising these opportunities. The new Computational Sciences Center of Excellence (CoE) is a strategic, unified group whose goal is to harness this transformative power of data and Artificial Intelligence (AI) to assist our scientists in both pRED and gRED to deliver more innovative and transformative medicines for patients worldwide.
This role will ensure that gRED and pRED are supported and enabled with world-leading data, analytical, and computational biology approaches in Oncology while developing our projects through the pre-clinical and clinical stages. This role is a leader of leaders, leading teams with a broad scope of bioinformatics, biostatistics, specialised disease and data science expertise with a primary focus on Oncology.
As the Executive Director of Computational Biology - Oncology, you lead a team developing innovative data analysis solutions for target identification, target assessment, disease understanding, molecule characterization (mode of action, safety, etc.), improving predictive validity of pre-clinical models as well as supporting clinical development strategies by characterizing patient populations and identifying biomarker candidates. You drive impact on the gRED and pRED portfolio, build strong stakeholder relationships, and set strategy for your team and Roche. Your responsibilities include making decisions on talent, resourcing, business processes, and capability development, contributing to the organization's overall success.
**The Opportunity:**
+ Strategic leadership of the Computational Biology - Oncology department within Computational Center of Excellence and member of the Computational Biology and Medicine LT
+ Define vision and strategy for computational biology in Oncology to achieve gRED and pRED objectives and implement world-leading approaches in portfolio projects to identify and assess new targets and to support the characterization of molecules and models that inform data driven decisions along the value chain.
+ Responsible for hiring, developing, and retaining talent, fostering an environment for team members to broaden their skills for enhanced outcomes
+ Ensure standardized tools and pipelines for computational biology, collaborating closely with biologists and computational leaders for efficient data flow and decision-making
+ Drive innovation in analysis approaches, establish strong internal and external partnerships, and lead by example to demonstrate and align with our core values
**Who You Are:**
+ PhD in a scientific or technical field with 15+ years of experience, including significant group management and team formation
+ Deep expertise in computational biology, bioinformatics, biostatistics, data science, or similar fields
+ Proven expertise in pre-clinical and clinical research in Oncology.
+ Proven experience leading large teams, involving multiple stakeholders, and achieving outstanding results efficiently
+ Excellent partnering and collaboration skills, building trustful partnerships with internal and external stakeholders
+ Deep understanding of how biological data analysis impacts decision-making along the value chain
+ Ability to lead a multidisciplinary team, quickly understand topics, formulate problem statements, and achieve successful outcomes
+ Willingness to travel regularly to ensure exchange with your global team members and stakeholders.
+ Thrives in ambiguity, identifying opportunities, and bringing clarity to the team while fostering a growth mindset and development opportunities for direct reports.
Relocation benefits are available for this job posting.
This role will be based in the South San Francisco or Basel campus and onsite presence is expected.
The expected salary range for this position based on the primary location of California is $249,600 - $463,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits (****************************************************
\#LI-JD1
\#ComputationCoE
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
Executive Director, Computational Biology - Oncology
Executive director job at Genentech
A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.
Advances in AI, data, and computational sciences are transforming drug discovery and development. Roche's Research and Early Development organisations at Genentech (gRED) and Pharma (pRED) have demonstrated how these technologies accelerate R&D, leveraging data and novel computational models to drive impact. Seamless data sharing and access to models across gRED and pRED are essential to maximising these opportunities. The new Computational Sciences Center of Excellence (CoE) is a strategic, unified group whose goal is to harness this transformative power of data and Artificial Intelligence (AI) to assist our scientists in both pRED and gRED to deliver more innovative and transformative medicines for patients worldwide.
This role will ensure that gRED and pRED are supported and enabled with world-leading data, analytical, and computational biology approaches in Oncology while developing our projects through the pre-clinical and clinical stages. This role is a leader of leaders, leading teams with a broad scope of bioinformatics, biostatistics, specialised disease and data science expertise with a primary focus on Oncology.
As the Executive Director of Computational Biology - Oncology, you lead a team developing innovative data analysis solutions for target identification, target assessment, disease understanding, molecule characterization (mode of action, safety, etc.), improving predictive validity of pre-clinical models as well as supporting clinical development strategies by characterizing patient populations and identifying biomarker candidates. You drive impact on the gRED and pRED portfolio, build strong stakeholder relationships, and set strategy for your team and Roche. Your responsibilities include making decisions on talent, resourcing, business processes, and capability development, contributing to the organization's overall success.
The Opportunity:
* Strategic leadership of the Computational Biology - Oncology department within Computational Center of Excellence and member of the Computational Biology and Medicine LT
* Define vision and strategy for computational biology in Oncology to achieve gRED and pRED objectives and implement world-leading approaches in portfolio projects to identify and assess new targets and to support the characterization of molecules and models that inform data driven decisions along the value chain.
* Responsible for hiring, developing, and retaining talent, fostering an environment for team members to broaden their skills for enhanced outcomes
* Ensure standardized tools and pipelines for computational biology, collaborating closely with biologists and computational leaders for efficient data flow and decision-making
* Drive innovation in analysis approaches, establish strong internal and external partnerships, and lead by example to demonstrate and align with our core values
Who You Are:
* PhD in a scientific or technical field with 15+ years of experience, including significant group management and team formation
* Deep expertise in computational biology, bioinformatics, biostatistics, data science, or similar fields
* Proven expertise in pre-clinical and clinical research in Oncology.
* Proven experience leading large teams, involving multiple stakeholders, and achieving outstanding results efficiently
* Excellent partnering and collaboration skills, building trustful partnerships with internal and external stakeholders
* Deep understanding of how biological data analysis impacts decision-making along the value chain
* Ability to lead a multidisciplinary team, quickly understand topics, formulate problem statements, and achieve successful outcomes
* Willingness to travel regularly to ensure exchange with your global team members and stakeholders.
* Thrives in ambiguity, identifying opportunities, and bringing clarity to the team while fostering a growth mindset and development opportunities for direct reports.
Relocation benefits are available for this job posting.
This role will be based in the South San Francisco or Basel campus and onsite presence is expected.
The expected salary range for this position based on the primary location of California is $249,600 - $463,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
#LI-JD1
#ComputationCoE
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Exec Director, MSAT
La Verne, CA jobs
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
Job Responsibilities
• Provide leadership related to best Practices pertaining to tech transfer and validation
• Interface with Senior Leadership Team to provide a unified set of goals and objectives for the dept.
• Assist with onboarding of new technologies and provide oversight for new qualification programs.
• Ensure growth and development of staff to meet changing business needs.
• Conducts and serves as a lead/coordinator of investigations and corrective and preventative action
(CAPA) recommendations related to tech services and validation activities.
• Interfaces with Regulatory agencies as required representing Gilead to authorities and regulatory
inspectorates in matters relating to GMP.
• Leads standardization and harmonization of Standard Operating Procedures, leveraging existing
Gilead Quality Systems.
Ensure coordination and synchronization between the two groups (tech transfer and validation) for the benefit of new product introduction or projects
1/ Tech Services
Lead strategic and tactical operations of a team across the Technical Services Department. Ultimate responsibility for staff development, budgeting and cost control, and strategic planning of a Technical Services department.
Provides direction and assistance on resolution of complex issues, and potential problems related to multiple drug forms.
Accountable for developing action plans for future implementation of systems to meet long-term objectives.
Acts as an escalation point for complex/high impact technical services issues/decisions.
May lead cross-functional PDM teams for a program with responsibility for the planning and execution of program strategy through all stages of development.
For commercial manufacturing, leads commercial projects with responsibility and accountability for commercial process performance, CPV, optimization, and investigations.
Directs the planning and execution of process development while considering process efficiency, scalability, safety, regulatory factors, and cost of goods.
May act as an advisor to senior management on process development and corporate research and development direction.
Determines organizational objectives and interprets company policies to meet company goals.
Reviews and approves capital expenditure.
Ensures that all departments operate in accordance with department SOPs which meet regulatory and GMP standards.
Liaises with Pharmaceutical Manufacturing and Pharmaceutical Development teams across Gilead on the technical transfer of new products across identified sites.
May serve as liaison between the company and various governmental agencies.
Assists in any investigation within the company including but not limited to the handling of deviations, complaints, Out of Specification Investigations, Material Review Boards, associated investigations, finished product trending, and change control.
2/ Validation
Oversee the development and implementation of commissioning and validation strategy for Gilead portfolio of products and/or across engineering and validation sub-functions.
Manages the strategic and tactical operations of the validation department.
Ultimate responsibility for staff development, budgeting and cost control, and strategic planning of the validation department.
Oversees the development and implementation of validation strategy for Gilead portfolio of products and/or across validation sub-functions.
Establishes and publishes Key Performance Indicators to track GMP, GDP compliance across operations.
Works with senior and executive management, develops plans and strategic direction for the validation function
Collaborates cross-functionally with stakeholders to ensure that product validation processes are aligned to the needs of Gilead and its customers, ensuring that best practice, compliance and alignment with business needs.
Knowledge & Skills
Demonstrates extensive knowledge of industry best practices and trends.
Is able to develop and improve complex concepts, techniques, standards and new applications. Is able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.
Is able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
Demonstrates exceptional verbal, written, and interpersonal communication skills.
Has proven experience and ability to manage staff.
Demonstrates deep knowledge and experience in technical services as well as industry best practices and trends
Must have in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
Education & Experience
Education & Experience
16+ years of experience in the pharmaceutical industry and a BS or BA OR 14+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
Prior people management and leadership experience.
Deep knowledge and experience in validation and tech transfer in highly regulated manufacturing environments is preferred.
Experience with Biologics Products and Sterile manufacturing.
Biopharmaceutical or Pharmaceutical experience required.
Must be willing to be based out of the La Verne, CA site
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:
******************************************************************
* 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.
Auto-ApplyExecutive Director, US Medical Affairs (USMA) Strategy - Liver and Covid
Foster City, CA jobs
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**
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, primary biliary cholangitis and cancers. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
**Job Overview:**
The Executive Director (ED) USMA Strategy - Liver and Covid is a key member of the USMA leadership team, reporting to the VP of USMA, Virology, and office-based in Foster City, CA. This role is responsible for developing and driving the USMA strategies and respective medical annual plannings for Viral Hepatitis, Primary Biliary Cholangitis (PBC) and Covid-19 and provide representation in cross-functional HBV, HCV, HDV, PBC and COVID-19 working groups. The ED will oversee, develop, and maintain the tenor of Gilead's US scientific communications related to Viral Hepatitis, PBC and COVID-19 with the community of US health care professionals and advocates, ensuring high-quality deliverables such as medical affairs resources, medical presentations at conferences, advisory boards and medical engagements with US providers and advocates. Experience with launch planning and external collaborations will also be essential.
**Responsibilities:**
+ Develop, innovate, and execute USMA Viral Hepatitis, PBC and COVID-19 Plans of Action based on landscape assessment of unmet medical needs and anticipation of future industry trends and opportunities, collaborating with colleagues across the Development and US organization based in Foster City, CA.
+ Serve as USMA Head of Liver and COVID-19 at cross-functional meetings, representing the US perspective and needs in working groups with respective Clinical Development, Global Medical Affairs, US Commercial, US Government Affairs and Policy, US Public Affairs, US Regulatory, and US legal and compliance
+ Represent US data gaps and research needs related to viral hepatitis, PBC and Covid-19.
+ Assess medical education needs and generate insights related to liver and Covid-19 in the US healthcare.
+ Provide scientific leadership at key US conferences.
+ Provide inspirational leadership to the USMA Liver and COVID-19 Strategy teams by creating an environment of mutual respect, shared goals, clear responsibilities, and talent development.
**Basic Qualifications**
+ M.D., D.O., PharmD, or PhD in life sciences degree with 14+ years of relevant Medical Affairs industry experience OR
+ MA / MS in life sciences degree with 14+ years of relevant Medical Affairs industry experience OR
+ BS / BA in life sciences degree with 16+ years of relevant Medical Affairs industry experience
**Preferred Qualifications**
+ M.D., D.O., PhD (in life sciences), PharmD, NP or PA with over 12 years of extensive experience in hepatology or infectious diseases; a minimum of 5 years of relevant Medical Affairs industry experience is required.
+ Provide clear leadership and management in the development and delivery of a variety of highly complex projects with the ability to assess, understand and communicate the latest scientific information.
+ Excellent strategic and organizational skills to manage direct reports and matrix teams with ability to anticipate, organize and prioritize workload on multiple ongoing projects and meet timelines in a fast-paced environment.
+ Excellent analytical and critical thinking skills to assess the validity and relevance of study concepts, protocols, data results, and publications to lead prioritized US data generation and research needs.
+ Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for US Medical Affairs activities.
+ Able to work with a level of autonomy and independence and able to manage budgeting/oversight of operational expenses.
+ Office-based position in Foster City, CA with the ability to travel up to 25 percent to attend cross-functional meetings and conferences.
**Gilead Core Values:**
+ Integrity (Doing What's Right)
+ Teamwork (Working Together)
+ Excellence (Being Your Best)
+ Accountability (Taking Personal Responsibility)
+ Inclusion (Encouraging Diversity)
The salary range for this position is: $349,010.00 - $451,660.00. 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:
******************************************************************
* 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
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.
Executive Director, US Medical Affairs (USMA) Strategy - Liver and Covid
Foster City, CA jobs
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
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, primary biliary cholangitis and cancers. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Job Overview:
The Executive Director (ED) USMA Strategy - Liver and Covid is a key member of the USMA leadership team, reporting to the VP of USMA, Virology, and office-based in Foster City, CA. This role is responsible for developing and driving the USMA strategies and respective medical annual plannings for Viral Hepatitis, Primary Biliary Cholangitis (PBC) and Covid-19 and provide representation in cross-functional HBV, HCV, HDV, PBC and COVID-19 working groups. The ED will oversee, develop, and maintain the tenor of Gilead's US scientific communications related to Viral Hepatitis, PBC and COVID-19 with the community of US health care professionals and advocates, ensuring high-quality deliverables such as medical affairs resources, medical presentations at conferences, advisory boards and medical engagements with US providers and advocates. Experience with launch planning and external collaborations will also be essential.
Responsibilities:
Develop, innovate, and execute USMA Viral Hepatitis, PBC and COVID-19 Plans of Action based on landscape assessment of unmet medical needs and anticipation of future industry trends and opportunities, collaborating with colleagues across the Development and US organization based in Foster City, CA.
Serve as USMA Head of Liver and COVID-19 at cross-functional meetings, representing the US perspective and needs in working groups with respective Clinical Development, Global Medical Affairs, US Commercial, US Government Affairs and Policy, US Public Affairs, US Regulatory, and US legal and compliance
Represent US data gaps and research needs related to viral hepatitis, PBC and Covid-19.
Assess medical education needs and generate insights related to liver and Covid-19 in the US healthcare.
Provide scientific leadership at key US conferences.
Provide inspirational leadership to the USMA Liver and COVID-19 Strategy teams by creating an environment of mutual respect, shared goals, clear responsibilities, and talent development.
Basic Qualifications
M.D., D.O., PharmD, or PhD in life sciences degree with 14+ years of relevant Medical Affairs industry experience OR
MA / MS in life sciences degree with 14+ years of relevant Medical Affairs industry experience OR
BS / BA in life sciences degree with 16+ years of relevant Medical Affairs industry experience
Preferred Qualifications
M.D., D.O., PhD (in life sciences), PharmD, NP or PA with over 12 years of extensive experience in hepatology or infectious diseases; a minimum of 5 years of relevant Medical Affairs industry experience is required.
Provide clear leadership and management in the development and delivery of a variety of highly complex projects with the ability to assess, understand and communicate the latest scientific information.
Excellent strategic and organizational skills to manage direct reports and matrix teams with ability to anticipate, organize and prioritize workload on multiple ongoing projects and meet timelines in a fast-paced environment.
Excellent analytical and critical thinking skills to assess the validity and relevance of study concepts, protocols, data results, and publications to lead prioritized US data generation and research needs.
Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for US Medical Affairs activities.
Able to work with a level of autonomy and independence and able to manage budgeting/oversight of operational expenses.
Office-based position in Foster City, CA with the ability to travel up to 25 percent to attend cross-functional meetings and conferences.
Gilead Core Values:
Integrity (Doing What's Right)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
Inclusion (Encouraging Diversity)
The salary range for this position is: $349,010.00 - $451,660.00. 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:
******************************************************************
* 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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.
Auto-ApplyExec Director, Regulatory Affairs-Combination Products & Devices
Foster City, CA jobs
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
* Strategic Leadership & Vision
Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations. Champion regulatory innovation and novel approaches to accelerate development and approval timelines. Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and devices.
* Global Regulatory Excellence
Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure regulatory conformance and consistency across markets, maintaining compliance with evolving health authority requirements and internal governance.
* Enterprise Collaboration & Influence
Cultivate strong, collaborative relationships across Gilead's global functions, including Quality, Manufacturing, Technical Development, Clinical Development, and Supply Chain. Influence cross-functional decision-making and regulatory planning without direct authority, operating effectively in a matrixed environment. Remain apprised of the current best practices across the industry, as well as serve as a liaison across other regulatory functions.
* Program Oversight & Governance
Provide strategic direction and oversight for late-stage development programs. Guide combination and packaging development teams, ensuring integrated execution across all development functions. Lead major regulatory applications and lifecycle management strategies. In addition, include early and late-stage programs in scope, as teams are working earlier on TPPs and product strategies.
* Regulatory Operations & Submissions
Oversee the drafting, review, and approval of CMC sections for regulatory filings. Provide leadership for agency interactions, inspections, and regulatory responses. Ensure readiness and compliance for global commercialization.
* Design Control & Technical Strategy
Provide strategic input to Design Control processes and documentation, ensuring alignment with FDA 21 CFR Part 4 and global technical standards. Contribute expertise to design history files, human factors studies, and process characterization.
* Leadership & Culture
Model Gilead's Core Values, Leadership Commitments, and People Leader Accountabilities. Foster a culture of integrity, excellence, and continuous improvement within the global CMC RA organization.
QUALIFICATIONS
* A scientific degree with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD.
* Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.).
* Experience with leading NDA/BLA submission and approvals including global Health Authority Interactions.
* Application of sound and accurate judgment to make timely decisions.
* Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives.
* Demonstrated organizational leadership skills at both functional and enterprise levels.
* Excellent strategic acumen, collaboration, and communication skills are required.
* Experience supporting multiple regulatory filings including IND/IDE and NDA/BLA and supporting product-related inspections for US and foreign regulatory agencies.
* In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of small molecules and biologics.
* Proven track record in the successful development and commercialization of device technologies, innovation, and championing business practice improvements.
* Experience leading major initiatives to improve organizational capabilities.
* Demonstrated strategic thinking and influencing skills internally and externally.
* Sound working knowledge of global regulatory requirements for Combination Products/ Devices.
* Excellent leadership, collaboration and communication skills, as well as the proven ability to drive innovation and influence organization change.
* Solid understanding of current industry trends and regulatory expectations associated with QbD, comparability evaluation, scale up, and method and process validation.
The salary range for this position is:
Other US Locations: $274,550.00 - $355,300.00.
Bay Area: $302,005.00 - $390,830.00.
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:
******************************************************************
* 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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.
Auto-ApplyExec Director, Regulatory Affairs-Combination Products & Devices
Foster City, CA jobs
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**
· **Strategic Leadership & Vision**
Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations. Champion regulatory innovation and novel approaches to accelerate development and approval timelines. Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and devices.
· **Global Regulatory Excellence**
Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure regulatory conformance and consistency across markets, maintaining compliance with evolving health authority requirements and internal governance.
· **Enterprise Collaboration & Influence**
Cultivate strong, collaborative relationships across Gilead's global functions, including Quality, Manufacturing, Technical Development, Clinical Development, and Supply Chain. Influence cross-functional decision-making and regulatory planning without direct authority, operating effectively in a matrixed environment. Remain apprised of the current best practices across the industry, as well as serve as a liaison across other regulatory functions.
· **Program Oversight & Governance**
Provide strategic direction and oversight for late-stage development programs. Guide combination and packaging development teams, ensuring integrated execution across all development functions. Lead major regulatory applications and lifecycle management strategies. In addition, include early and late-stage programs in scope, as teams are working earlier on TPPs and product strategies.
· **Regulatory Operations & Submissions**
Oversee the drafting, review, and approval of CMC sections for regulatory filings. Provide leadership for agency interactions, inspections, and regulatory responses. Ensure readiness and compliance for global commercialization.
· **Design Control & Technical Strategy**
Provide strategic input to Design Control processes and documentation, ensuring alignment with FDA 21 CFR Part 4 and global technical standards. Contribute expertise to design history files, human factors studies, and process characterization.
· **Leadership & Culture**
Model Gilead's Core Values, Leadership Commitments, and People Leader Accountabilities. Foster a culture of integrity, excellence, and continuous improvement within the global CMC RA organization.
**QUALIFICATIONS**
+ A scientific degree with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD.
+ Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.).
+ Experience with leading NDA/BLA submission and approvals including global Health Authority Interactions.
+ Application of sound and accurate judgment to make timely decisions.
+ Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives.
+ Demonstrated organizational leadership skills at both functional and enterprise levels.
+ Excellent strategic acumen, collaboration, and communication skills are required.
+ Experience supporting multiple regulatory filings including IND/IDE and NDA/BLA and supporting product-related inspections for US and foreign regulatory agencies.
+ In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of small molecules and biologics.
+ Proven track record in the successful development and commercialization of device technologies, innovation, and championing business practice improvements.
+ Experience leading major initiatives to improve organizational capabilities.
+ Demonstrated strategic thinking and influencing skills internally and externally.
+ Sound working knowledge of global regulatory requirements for Combination Products/ Devices.
+ Excellent leadership, collaboration and communication skills, as well as the proven ability to drive innovation and influence organization change.
+ Solid understanding of current industry trends and regulatory expectations associated with QbD, comparability evaluation, scale up, and method and process validation.
The salary range for this position is:
Other US Locations: $274,550.00 - $355,300.00.
Bay Area: $302,005.00 - $390,830.00.
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:
******************************************************************
* 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
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.
Executive Director, US HIV Integrated Insights & Strategy
Foster City, CA jobs
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
Reporting to the Vice President of US Integrated Insights & Digital, our HIV Executive Director acts as a partner and advisor to the HIV Prevention Business Unit Vice President and HIV Prevention Executive Directors and will be a member of the US Leadership team. As a strategic analytical thought partner, you will help frame key business questions and connect the dots across Integrated Insights to provide performance analysis with actionable insights, influence decision-making, and set priorities for current, late-stage pipeline products, and market expansion analytics. The successful candidate will integrate analytics and insights to inform solutions that drive business performance.
Our Executive Director will have ≈12 team members across Market Research, Analytics, and Forecasting. You will be responsible for creating an environment where teams are highly motivated and engaged, working together (and cross-functionally) to deliver exceptional results and ensure long-term success. Proven ability to influence without authority and strong collaboration are critical for success.
Specific Job Responsibilities:
Lead a team of ~12 to integrate analytics and insights and make data-driven recommendations to advance the portfolio (inclusive of the entire portfolio across all products and indications)
Serve as a single point of contact to the US Business Unit Vice President for priorities across customer insights, forecasting, and analytics to help the Integrated Insights team align on a single set of priorities and track actions being taken against each of them
Develop productive relationships with the VP to define objectives, budgets, and work plans
Engage with Integrated Insights leadership and cross-functional teams (e.g., Global Analytics & Insights team, US Commercial Finance) to determine key business questions and needs to shape strategies and tactics to successfully meet business objectives collaboratively
Provide earnings support on narrative
Enable connections across analytical and research efforts to tell a cohesive story on brand performance and allow strategic recommendations
Seek opportunities to streamline and improve business operations and technical capabilities of the organization while identifying opportunities to innovate to drive performance
Basic Qualifications:
Bachelor's Degree and Sixteen Years' Experience OR
Masters' Degree and Fourteen Years' Experience OR
Ph.D. and Fourteen Years' Experience
Preferred Qualifications:
Relevant experience in analytics, finance and insight's role and previous experience is required.
Strong leadership track record with proven ability to lead without authority and collaborate cross-functionally
Thorough understanding of pharmaceutical sales and marketing practices, product lifecycle management, and regulatory environment.
Demonstrated ability to drive large cross-functional initiatives and influence laterally and vertically.
Ability to manage multiple priorities based on changing business needs, as well as ability to work in a team-based, fast-paced environment.
Strong organizational, planning, communication, and project management skills.
Strong understanding of primary qualitative and quantitative market research techniques and their optimal use in business decisions.
Persuasive written and verbal communication skills, ability to lead, influence, resolve conflict, and drive consensus among diverse cross-functional stakeholders
People Leader Accountabilities
•Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
•Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
•Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $302,005.00 - $390,830.00. 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:
******************************************************************
* 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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.
Auto-ApplyExecutive Director of Biostatistics (Inflammation)
Foster City, CA jobs
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
Reporting to the Head of Biometrics, the Executive Director of Biostatistics for Inflammation will lead the Biostatistics function within Inflammation Therapeutic Area (TA), and oversee all biostatistics workstreams for clinical trials, assets evaluations, and regulatory submissions in the TA. The ideal candidate will have a proven track record of functional leadership, strategic situational judgement in using both innovative and pragmatic statistics, as well as demonstrated motivation for and excellence in people management and development.
This role is an onsite opportunity at our global headquarters in Foster City, CA.
Responsibilities
Provides statistical oversight of all biostatisticians in the TA and all biostatistics-related work conducted by internal biostatisticians and external consultants for the TA.
Provides strategic inputs and statistical expertise for clinical development programs. Partners and collaborates with cross-functional TA leads to meet the regulatory, scientific and business objectives.
Oversees and contributes to the completion of all technical and operational statistical activities in the TA through management of internal and external resources.
Anticipates emerging projects in the TA and works with senior management to develop staffing plan. Properly assigns and manages resource according to priorities and development strategies.
Negotiates project timelines across programs with competing priorities given constraints. Manages and coordinates limited resources to produce quality deliverables within timelines.
Ensures adherence to SOPs, BEDs, and all departmental standards and processes regarding the conduct of clinical trials, statistical methodology, data analysis and interpretation.
Champions the development and training of decision-enabled statistical tools. Explores opportunities for more efficient and innovative statistical approaches.
Responsible for ensuring scientific integrity of the statistical methodology applied to clinical trials. Accountable for ensuring rigorous statistical approaches implemented in the TA.
Encourages and empowers biostatisticians to exercise good judgement, embrace data-driven approach, and follow the best practices and principles to become accountable decision-makers.
Capabilities & Requirements:
Excellent verbal and written communication skills. Excellent negotiation and interpersonal skills
In depth knowledge of the drug development process. In depth knowledge of and strong advocate for Good Clinical Trial Practices, ICH, and regulatory guidance.
Proven ability to supervise team leads who supervise personnel. Ability to delegate, coach, and provide feedback and career development opportunities to team-members.
Ability to provides team-members with a framework for decision-making that delineates the actions associated with the decisions made under the framework and recognizes that appropriate actions taken in the present impact the chance of positive outcomes in the future.
Excellent judgment and problem-solving skills in complex situations. Ability to identify the most important aspects of an issue. Ability to make effective evidence-based decisions even when information is limited, or solutions may produce unpleasant consequences in the short term.
Ability to provide overall leadership for one or more departmental strategic initiatives. Ability to assess need for changing processes, and to recommend and implement new infrastructure and/or processes to improve efficiency and quality.
Ability to integrate planning efforts across departments to ensure organizational effectiveness. Ability to drive change and influence decision making.
Ability to advise and influence senior leadership/functional leads on biostatistics strategies as well as functional issues that have a business impact. Ability to use competitive intelligence to influence clinical development strategies.
Inflammation drug development experience is required, including the design and conduct of clinical studies from early through late stage development and regulatory interactions.
PhD degree in Biostatistics or equivalent and minimum 15 years of industry experience is preferred.
More specific responsibilities for Biostatistics TA Head
Participate in DRC and other TA-lead-level cross-functional meetings, and represent Biostatistics function.
Conduct regular TA meetings and disseminate TA information within the Biostatistics team, and with other functions as needed.
Provide clarity on expectations for all biostatisticians within the TA, including delegation, decision-making, and communication framework. Provide constant constructive feedback accordingly.
Develop talent action plans to ensure retention of (top) talents. Anticipate upcoming challenges, identify potential capability gaps, and utilize internal/external resource to bridge the gaps.
Coordinate processes, training and other managerial activities with BLT members. Assess and address potential compliance risks and ensure audit/inspection readiness within and across TAs.
Participate in Biostatistics leadership meeting and other department-related meetings. Keep Head of Biometrics informed with major development in the TA.
The salary range for this position is: $302,005.00 - $390,830.00. 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:
******************************************************************
* 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.
Auto-ApplyExec Director, PDM Strategy
Foster City, CA jobs
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
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.
Executive Director, Head of PDM Strategy - Foster City, California
KEY RESPONSIBILITIES
Reporting to Vice President, Pharmaceutical Development and Manufacturing (PDM) Strategy & Operations, you will lead a team of professionals to develop an enterprise-focused strategy for PDM and provide clarity for leaders and decision makers in the organization. This includes leading enterprise and PDM-focused strategic analysis projects and key initiatives
FOCUS AREAS
Develop, revise and maintain PDM's network strategies for all aspects of clinical & commercial manufacturing. Codify existing strategies, develop strategic operating principles and formulate new network strategies depending on the business and organizational needs.
Support the PDM Leadership Team with cross-functional strategic initiatives and decision-making
Lead strategic analysis and option evaluations by leading an internal consulting team, capable of replacing the external consultants we have used for strategy analysis work previously.
When appropriate, manage engagements with external consulting companies with project costs of the order of $1M. This includes executing the scope definition, RFP, bid assessment, vendor selection and vendor management.
Define and execute a PDM risk management process to fit with the Gilead enterprise requirements.
Stand up a business intelligence / competitive intelligence function to PDM. Participate in external benchmarking and manage the consequent data gathering and analysis exercises.
Scan the Gilead and industry environment for relevant trends that could impact on PDM and its ability to deliver.
Build out a sustainability strategy for PDM in alignment with Gilead's sustainability goals
QUALIFICATIONS
The following are required:
Bachelor's degree and 15+ years of relevant experience, or master's degree / PhD / MD with 12+ years of relevant experience.
3+ years at top-tier consulting firm or in a similar role developing manufacturing and technical development strategy in the bio-pharma industry.
Extensive experience in the biotech or pharmaceutical industry with demonstrated cross-functional collaboration and leadership; deep knowledge about the biotech / biopharma segment.
Strong business acumen.
Demonstrated capability to deliver strategic analysis and optionality impacting the effectiveness of a global manufacturing and development organization.
Demonstrated ability to lead a team of multi-disciplinary professionals in delivering strategy analysis and recommending options.
Excellent coaching and influencing skills.
Cross-functional and enterprise-wide relationship building skills.
A passion for developing people and supporting a team.
A strong business process orientation but able to deploy processes practically and with the maximum impact.
Understanding of the complexity of multi-national supply chains and the geopolitical factors impacting technical development and manufacturing in the bio-pharma industry.
Excellent interpersonal skills with ability to lead, interact with, focus, negotiate, resolve conflict, and drive consensus among individuals from a variety of cultures and disciplines.
Highly adept at influencing upward and downward without positional authority.
Drives forward in face of ambiguity.
Bias for action; ability to prioritize.
Strong leadership, self-direction, comfort and experience tackling ambiguous and complex problems.
Excellent communication skills with the ability to synthesize complex situations, illustrate conceptual paths, and facilitate discussions leading to resolution on key issues.
The following are Preferred:
Bachelor's degree and 20+ years of relevant experience, or master's degree / PhD / MD with 15+ years of relevant experience.
5+ years at top-tier consulting firm or in a similar role developing manufacturing and technical development strategy in the bio-pharma industry.
Ability to multi-task and independently lead multiple projects and meet key deadlines.
High EQ, ability to listen, and adaptability to dynamic of situation.
Confidence to provide dissenting views when appropriate.
Ability to work cross-functionally and understand the motivations of colleagues in other functions.
Deep experience in designing and deploying rigorous processes, tools, templates, and governance.
Proven ability to lead collaborative and creative strategic problem solving by breaking down issues, identifying options to address, synthesizing insights, and driving to action and resolution.
Gilead Core Values
Integrity (Doing What's Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 ****************** for assistance.
The salary range for this position is:
Bay Area: $302,005.00 - $390,830.00.
Other US Locations: $274,550.00 - $355,300.00.
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:
******************************************************************
* 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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.
Auto-ApplyExec Director, Formulation & Process Development
Foster City, CA jobs
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.
Executive Director, Formulation and Process Development
The Executive Director of Formulation and Process Development will be responsible for leading the development and commercialization of small molecule drug product including proteins/peptides from drug discovery to product commercialization. In addition, the incumbent will be a member of the Technical Development Leadership Team, that is responsible for providing leadership and decisions on the development and commercialization strategies of all modalities.
Responsibilities:
Provide leadership and direction to the Formulation and Process Development organization, a department of >70 scientists for small molecule formulations including oral solid dosage forms and sterile injectables
Responsible for the design & development of products for all small molecule, peptides, and synthetic oligonucleotides NMEs from lead optimization to commercialization Provide technical, operational, and strategic guidance on a wide range of activities across all development stages (lead optimization of pre-clinical drug candidates, preformulation, formulation development, process scale-up, technology transfer, process validation of clinical drug candidates, and commercial support)
Demonstrate a thorough understanding of the cGMP environment (internal and external cGMP manufacturing operations) and compliance requirements.
Provide guidance and strategic directions through interactions with each formulation and process development (FPD) team
Ensure successful transfer of new products and technology to internal and external clinical and commercial manufacturing sites, including generation of knowledge and understanding to support product robustness targets
Serve as a senior member of the Technical Development Leadership Team responsible for developing and establishing small molecule strategy
Evaluate and implement new technologies to drive innovation in Formulation and Process Development for small molecules
Drive development and implementation of new systems to improve project execution and data management
Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Reg, Manufacturing and Technical Operations, Product and Portfolio Management, Finance and Supply Chain,
Ensure strong relationships with key stakeholder functions including Research, Clinical Development, and Clinical Supply Management and Product Strategy Teams by providing technical and strategic input
Hire, mentor and develop team members within the organization
Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections
Provide technical support to internal and external cGMP manufacturing operations
Develop and manage department budget
Qualifications:
Ph.D. in pharmaceutical sciences or related sciences with at least 15 years of experience in pharmaceutical development and a record of roles with increasing responsibility
In-depth knowledge and understanding of drug product development, commercial technology transfer to manufacturing, CMC related FDA and international regulations
Previous success working effectively in a multidisciplinary, highly matrixed environment
Demonstrated ability to build a team and develop a high performing organization
Excellent decision-making, written and verbal communication skills
Proven ability to lead high performing teams
Exceptional interaction, leadership and command skills are required
Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence.
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
Gilead Core Values
• Integrity (Doing What's Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 ****************** for assistance.
Job Description Translation
The salary range for this position is: $281,010.00 - $363,660.00. 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:
******************************************************************
* 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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.
Auto-ApplyExecutive Director, Global Clinical Supply Chain - Oncology
Foster City, CA jobs
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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
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.
Executive Director, Global Clinical Supply Chain (GCSC)
KEY RESPONSIBILITIES:
Executive Director, Global Clinical Supply Chain is responsible for leading clinical planning function within an assigned therapeutic area (TA). The incumbent is an end-to-end leader who inspires and motivates teams while leading the overall strategy supporting the GCSC function. Provides subject expertise on a diverse portfolio of development programs and different therapeutic modalities including small molecules, biologics and cell gene therapy for Gilead's global clinical trials.
The Executive Director works internally with members in GCSC and other functions including and are not limited to Development Operations, Clinical Operations and Process Development and Manufacturing (PDM) to develop strategies, meet project deliverables, solve business problems and create competitive advantage. This position includes end-to-end elements of clinical planning and execution from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide.
FOCUS AREA:
Establishes strategies to ensure uninterrupted clinical supply for the overall development portfolio, including clinical development programs and studies at all phases as well as managed access programs. May lead large complex projects within department and represent GCSC in cross-functional projects.
Leads, develops and manages team, which includes and not limited to recruitment, onboarding, and succession planning.
Drives excellence and accountable for setting clear goals and consistently delivering. Accountable for setting team goals in alignment with department and enterprise goals
Responsible for developing and maintaining a culture of continuous improvement. Mobilizes teams to develop plans, works cross functionally within PDM and at the enterprise level to identify and implement best practices.
Performs sponsor roles as requested.
Champions clinical demand and operation planning (CD&OP) interfacing with leaders from Clinical Operations, PDM sub-teams. Manages across enterprise functions and partners to ensure on time in full delivery of investigational medicinal product (IMP).
Ensures efficient and robust resource allocation for PDM sub-teams and clinical study teams.
Partners across several PDM functions and with other enterprise functions to ensure the on time in full (OTIF) delivery of IMP to initiate and resupply clinical studies.
Responsible for decision-making and direct the long-term vision of optimal supply chain strategies including labeling and distribution activities.
Responsible for risk balancing by allocating work. Identifies and champions areas where process improvements are imperative. Drives resolution of complex issues, through partner sponsors as needed.
Responsible for planning SOPs, Work Instructions, business policies and procedures to ensure GxP compliance. Influence cross-functional SOP content and review/approve as required.
Oversees and supports clinical study planners. Facilitates issue and risk identification, mitigation, resolution and communication.
Serves as the PDM sub-team for RFD assets, lead supply management for first in human (FIH) clinical trials.
Drives decision-making at cross-functional teams (ClinOps, PDM sub-teams) supporting the long-term vision.
Responsible for the departmental budgeting process - forecasts clinical supply spends, estimates headcount requirements as well as department related expenses (contractors, consultants, recruitment, project expenses, etc.).
Leads TA level allocations decisions and influences and negotiate partner performance.
Basic Qualifications:
16+ Years of relevant industry experience with BA/BS. OR 14+ Years with MA/MS or MBA PHD or PharmD.
Has an expert working knowledge of clinical supply chain best practices and experience working with a GxP environment.
Has strong cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company.
The candidate must demonstrate hands-on end-to-end clinical supply knowledge and experience with clinical trials in therapeutic area of oncology while maintaining elevated, strategic oversight at portfolio level.
Preferred Skills:
Degree in a science-related field; MS, PharmD, or MBA desirable.
Strong clinical supply management experience/knowledge in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations.
Prior experience in complex Oncology trials is highly-preferred.
Proven strong and effective collaboration, influencing and negotiation skills to work successfully with internal cross-functional group and external suppliers to meet the aggressive clinical study timeline and patient needs. Demonstrated ability to collaborate and build strategic relationships with internal and external stakeholders.
Possesses experience with clinical blinding practices in global study, from Phase 1 to Late Phase.
Possesses expert experience in sourcing and managing comparator drugs and other co-meds for clinical studies, and, in comparator sourcing strategy.
Expert knowledge of the FDA GxP standards and regulatory guidance documents such as CFR, Annex 13, EU CTR. Able to support regulatory inquiries both face-to-face and with appropriate responses.
Expert in leading through ambiguity, can assess options quickly and efficiently implement the best option in alignment with Gilead's culture and expectations for clinical timelines.
Excellent verbal, written and interpersonal communication skills are required. Must have the ability to write clear, concise and error free documents/presentations. Must be a confident communicator and presenter to all organizational levels.
Strong computer, database and organizational skills required. ERP, Planning System, and Project management experience is a plus.
Ability to effectively manage resources and timelines for multiple teams with studies of different complexities. Ability to lead or manage TA, department level and cross-functional projects.
Gilead Core Values
• Integrity (Doing What's Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)
The salary range for this position is: $281,010.00 - $363,660.00. 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:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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 log onto your Internal Career Site to apply for this job.
Auto-ApplyExecutive Director, Global Clinical Supply Chain - Oncology
Foster City, CA jobs
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
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.
Executive Director, Global Clinical Supply Chain (GCSC)
KEY RESPONSIBILITIES:
Executive Director, Global Clinical Supply Chain is responsible for leading clinical planning function within an assigned therapeutic area (TA). The incumbent is an end-to-end leader who inspires and motivates teams while leading the overall strategy supporting the GCSC function. Provides subject expertise on a diverse portfolio of development programs and different therapeutic modalities including small molecules, biologics and cell gene therapy for Gilead's global clinical trials.
The Executive Director works internally with members in GCSC and other functions including and are not limited to Development Operations, Clinical Operations and Process Development and Manufacturing (PDM) to develop strategies, meet project deliverables, solve business problems and create competitive advantage. This position includes end-to-end elements of clinical planning and execution from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide.
FOCUS AREA:
Establishes strategies to ensure uninterrupted clinical supply for the overall development portfolio, including clinical development programs and studies at all phases as well as managed access programs. May lead large complex projects within department and represent GCSC in cross-functional projects.
Leads, develops and manages team, which includes and not limited to recruitment, onboarding, and succession planning.
Drives excellence and accountable for setting clear goals and consistently delivering. Accountable for setting team goals in alignment with department and enterprise goals
Responsible for developing and maintaining a culture of continuous improvement. Mobilizes teams to develop plans, works cross functionally within PDM and at the enterprise level to identify and implement best practices.
Performs sponsor roles as requested.
Champions clinical demand and operation planning (CD&OP) interfacing with leaders from Clinical Operations, PDM sub-teams. Manages across enterprise functions and partners to ensure on time in full delivery of investigational medicinal product (IMP).
Ensures efficient and robust resource allocation for PDM sub-teams and clinical study teams.
Partners across several PDM functions and with other enterprise functions to ensure the on time in full (OTIF) delivery of IMP to initiate and resupply clinical studies.
Responsible for decision-making and direct the long-term vision of optimal supply chain strategies including labeling and distribution activities.
Responsible for risk balancing by allocating work. Identifies and champions areas where process improvements are imperative. Drives resolution of complex issues, through partner sponsors as needed.
Responsible for planning SOPs, Work Instructions, business policies and procedures to ensure GxP compliance. Influence cross-functional SOP content and review/approve as required.
Oversees and supports clinical study planners. Facilitates issue and risk identification, mitigation, resolution and communication.
Serves as the PDM sub-team for RFD assets, lead supply management for first in human (FIH) clinical trials.
Drives decision-making at cross-functional teams (ClinOps, PDM sub-teams) supporting the long-term vision.
Responsible for the departmental budgeting process - forecasts clinical supply spends, estimates headcount requirements as well as department related expenses (contractors, consultants, recruitment, project expenses, etc.).
Leads TA level allocations decisions and influences and negotiate partner performance.
Basic Qualifications:
16+ Years of relevant industry experience with BA/BS. OR 14+ Years with MA/MS or MBA PHD or PharmD.
Has an expert working knowledge of clinical supply chain best practices and experience working with a GxP environment.
Has strong cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company.
The candidate must demonstrate hands-on end-to-end clinical supply knowledge and experience with clinical trials in therapeutic area of oncology while maintaining elevated, strategic oversight at portfolio level.
Preferred Skills:
Degree in a science-related field; MS, PharmD, or MBA desirable.
Strong clinical supply management experience/knowledge in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations.
Prior experience in complex Oncology trials is highly-preferred.
Proven strong and effective collaboration, influencing and negotiation skills to work successfully with internal cross-functional group and external suppliers to meet the aggressive clinical study timeline and patient needs. Demonstrated ability to collaborate and build strategic relationships with internal and external stakeholders.
Possesses experience with clinical blinding practices in global study, from Phase 1 to Late Phase.
Possesses expert experience in sourcing and managing comparator drugs and other co-meds for clinical studies, and, in comparator sourcing strategy.
Expert knowledge of the FDA GxP standards and regulatory guidance documents such as CFR, Annex 13, EU CTR. Able to support regulatory inquiries both face-to-face and with appropriate responses.
Expert in leading through ambiguity, can assess options quickly and efficiently implement the best option in alignment with Gilead's culture and expectations for clinical timelines.
Excellent verbal, written and interpersonal communication skills are required. Must have the ability to write clear, concise and error free documents/presentations. Must be a confident communicator and presenter to all organizational levels.
Strong computer, database and organizational skills required. ERP, Planning System, and Project management experience is a plus.
Ability to effectively manage resources and timelines for multiple teams with studies of different complexities. Ability to lead or manage TA, department level and cross-functional projects.
Gilead Core Values
• Integrity (Doing What's Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)
The salary range for this position is: $281,010.00 - $363,660.00. 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:
******************************************************************
* 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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.
Auto-ApplyExecutive Director, Finance - FP & A
Santa Monica, CA jobs
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
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 Kite and help create more tomorrows.
**Job Description**
At Kite, a Gilead company, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day - discoveries that include our own capabilities and our individual potential.
We're currently seeking to recruit a highly motivated talent for the Kite Commercial Finance Executive Director role, to drive strategic business partnership and enhance the performance of the Kite business globally.
**Specific Responsibilities & Skills for this Position**
The Finance Executive Director will lead a team of approximately 10 professionals driving financial planning and analysis efforts for the Global Kite Commercial business. The successful candidate will be the business partner to the SVP of Kite Commercial and be responsible for managing revenues and expenses for Kite's CART products. This role will be a key partner to the Global Commercial Leadership Team providing guidance on strategic, operational, and financial issues. This position is located in Santa Monica, CA and reports to the VP Head of Finance for Kite. Success in this role will require the ability to cultivate an effective business partnership between the Commercial functional areas and Finance. The ED will be viewed as the business partner that provides strategic direction and is seen as the "go to person" for business financial analysis, insight, and counsel. This person will be responsible for demonstrating strong communication, influencing and strategic thinking skills that will drive value to the business.
**Essential Duties & Job Functions**
Responsibilities include:
+ Lead the 3 year budget and annual operational forecasts (LE's) for the Kite Global Commercial business, providing recommendations and business driven scenario analyses including P&L management
+ Support the 10 year US LRP process in partnership with Global Commercial functions
+ Provide guidance and analysis to support pricing and discounting decisions. This includes representing finance in cross functional reviews to recommend list prices for new products, setting the contracting and discounting strategy, and reviewing individual contract proposals
+ Oversee the monthly and quarterly close process, including managing the Gross to Net revenue process, expense accruals, management reporting, and budget vs. actual variance analysis. Report results to Commercial and Finance Sr Executives
+ Partner with Technical Accounting and the Commercial team to analyze and influence complex contract proposals that may have revenue recognition implications
+ Monitor and develop insights from key business drivers including demand, inventory, payer mix, pricing, and market share
+ Proactively recommend process improvements to increase the efficiency and effectiveness of reporting and analysis
+ Provide ad-hoc analyses and project support for the executive leadership team
+ Build a highly capable team and provide on-going managerial leadership and guidance to direct reports.
**Knowledge, Experience, & Skills**
+ The preferred candidate will possess 15-20 years' experience, having held positions of increasing scope and responsibility, including at least 5-10 years' experience as a senior finance leader and business partner.
+ A minimum of 5 years of management experience is required, growing teams of a minimum of 6 people.
+ A BS or BA is required, and a MBA or CPA is strongly preferred.
+ Prior experience in bio-tech or pharma is strongly preferred.
+ In-depth proficiency in aspects of accounting and finance and knowledge of US GAAP is required.
+ In depth knowledge of US Healthcare Systems, Business Intelligence, Planning and ERP systems is required with proficiency in Microsoft tools.
+ Experience in high-growth, multi-national organization a plus.
**The key competencies for this candidate are:**
+ Excellent interpersonal & business partnering skills: Cultivate collaborative relationships, including with both internal and external stakeholders. Proactively influence Senior Executive leadership on strategic issues which will drive value for Kite.
+ Organizational Impact: Ability to quickly establish credibility with diverse audiences and be perceived as a strategic thought partner on various business and financial related topics whose outcomes have a significant impact on Kite's value
+ Business Savvy and Financial Acumen: The candidate will possess technical knowledge on analytics, business foresight, problem-solving skills, an understanding of the US Payer, Access and Pricing landscape
+ Results Orientation: The ideal candidate will be results-driven and must thrive in a fast-paced, dynamic environment. You must have the ability to deliver results and possess a strong drive to meet and exceed goals and be willing to take ownership of problems and make sound decisions.
+ Team Leadership: You will lead, attract, train & develop a team of highly capable skilled finance professionals in both Santa Monica and London. You will be expected to align and motivate this team to achieve business & financial objectives including financial results, timely and accurate reporting, transparency, strong controls and analyzing the impact of market strategy.
+ Change Leadership: The candidate will be an independent self-starter and a proactive leader with a drive to strive for continuous improvement and consistently challenging the status quo. Will be viewed by business and cross functional partners, and Finance colleagues as a thought leader with strong influencing capabilities, who can also maintain open and transparent communication channels.
The salary range for this position is: $255,425.00 - $330,550.00. Kite 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:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ****************** . Sign up to follow @KitePharma on Twitter at ************************** .
**For jobs in the United States:**
Kite Pharma 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma 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.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
Executive Director, Global Supply Chain, Head of Planning
Santa Monica, CA jobs
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
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 Kite and help create more tomorrows.
**Job Description**
**Executive Director, Global Supply Chain, Head of Planning**
Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
We are looking for an Executive Director of Global Supply Chain, Head of Planning reporting to the Vice President of Global Supply Chain. As the Executive Director you will serve both as a senior leader on the Global Supply Chain Leadership team and as well as a key thought partner to the VP of Global Supply Chain immersed in both the strategic and operational elements critical to achieving the strategic objectives of Kite's best in class CAR-T Global Supply Chain organization, Kite Technical Operations, and Kite's mission to serve cancer patients. This includes leading a team tasked with providing critical business support for End-to-End Planning of the Supply Chain organization enabling Lifecycle Management of Kite's pipeline and commercial products, Network and Raw Materials Planning and Packaging & Labeling. The Incumbent will also work cross-functionally across other Technical Operations functions, Commercial and Clinical Business partners, and serve as a member of the Manufacturing Leadership Team.
**Responsibilities include:**
+ Responsible for leading all End-to-End Clinical and Commercial Supply Planning for Finished Product and Critical Input/Raw Materials Planning including internal and external Viral Vector Supply.
+ Partners with Commercial, Clinical, Process Development on demand forecast and supply plans for non-patient demand, clinical & commercial Vector and finished product.
+ Responsible for all ES&OP/S&OE governance and processes, projecting forward-looking inventory positions and financial implications to deliver target customer service levels, total costs and inventory health for Kite Manufacturing Network and C-level executives.
+ Responsible for all Clinical, Commercial Launch, Product Variation Management, Packaging & Labeling operations. Serves as advocate to shape CMC strategy and product decisions, deliver TechOps readiness for clinical trials and commercial launches, manages E2E process for labeling and packaging compliance with regional and global regulations.
+ Represents Global Supply Chain as a member of the Global Manufacturing Leadership Team/ CMC-TC seeking risk mitigation strategies across Supply Chain to ensure continuous patient supply.
**Basic Qualifications:**
+ PhD degree with 12+ years of experience within cGMP Supply Chain and/or Operations in a biopharmaceutical, cell therapy, or other highly regulated industry OR
+ MA / MS degree with 12+ years of experience within cGMP Supply Chain and/or Operations in a biopharmaceutical, cell therapy, or other highly regulated industry OR
+ BS / BA degree with 14+ years of experience within cGMP Supply Chain and/or Operations in a biopharmaceutical, cell therapy, or other highly regulated industry OR
+ High School Degree with 18+ years of experience within cGMP Supply Chain and/or Operations in a biopharmaceutical, cell therapy, or other highly regulated industry
+ Strong track record of clinical/lifecycle management and commercial planning in pharmaceutical or biopharmaceutical industry
**Preferred Qualifications:**
+ Proven track record in strategic work in collaboration with Manufacturing organizations across a variety of settings and topics in the pharmaceutical or biopharmaceutical industry
+ Strong experience in program and operational management including communicating across the organization to align on shared goals, identifying options and facilitating decisions to enable programs to move forward, resourcing and managing teams to meet goals and deliverables
+ Proven ability to effectively manage complex and ambiguous projects, influence stakeholders without direct authority, effectively network across the organization and communicate with executives/senior leaders all within a very dynamic, fast paced environment
+ Excellent analytical, interpersonal, influencing and leadership skills will be essential
+ Ability to effectively communicate cross-functionally with all levels of management through exceptional verbal and written communication skills
+ Exemplifies a Lean/continuous improvement mindset to drives tangible operational improvements
+ Experience with data analytics development lifecycle and methodology to ensure strong, accurate, and reliable analytical tools and dashboards
+ Strong people leader with an excellent ability to motivate, coach, develop and recruit others under their direct or indirect management
+ Highest level of integrity and management of confidential information
+ Be comfortable and efficient in a demanding, fast-paced, dynamic, often fluid environment.
+ Passion for Kite's mission and deep desire to have a meaningful impact on patient lives
The salary range for this position is: $255,425.00 - $330,550.00. Kite 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:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ****************** . Sign up to follow @KitePharma on Twitter at ************************** .
**For jobs in the United States:**
Kite Pharma 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma 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.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Kite Pharma Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
**Change The World With Us**
Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted.
While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
Executive Director, Clinical Development - Rare Disease
Thousand Oaks, CA jobs
Career CategoryClinical DevelopmentJob Description
JOIN AMGEN'S MISSION OF SERVING PATIENTS
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
With our focus on four therapeutic areas -Oncology, Rare disease, General Medicine, and Inflammation- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Executive Director, Clinical Development, Rare Disease
Live
What you will do
Let's do this. Let's change the world. In this vital role as an Executive Director, you will play an important role in scientific strategy and planning and execution for all aspects of clinical drug development across Amgen's clinical programs.
This Executive Director within Clinical Development will be involved with the full scope of the rare disease clinical drug development activities from the design and execution of Phase 2 through Phase 4 studies.
They will serve as the principal representative for global development within the rare disease therapeutic area to a range of audiences, including executive leadership, development partners, and global regulatory agencies.
This role will include global development leadership of one or more assets within the portfolio and require people management activities. The position will work closely with all members of the cross-functional product team to apply full clinical knowledge to successfully advance clinical programs, as well as the overall product strategy.
The Executive Director will report into the Vice President, Global Clinical Development.
Responsibilities
Serve as the global development leader for a product team with an enterprise mindset
Develop the clinical strategy for the product including indications and sequencing
Partner with clinical operations to deliver the studies
Manage clinical development medical and/or scientific directors working on various clinical trials for the product
Provide adequate oversight and mentoring of R&D personnel to design clinical development plans and protocols spanning all phases of development per indication in collaboration with product team members, key opinion leaders (KOLs) and CROs that are aligned with the target product profile
Provide adequate oversight into the development of the primary and secondary endpoints for efficacy and safety as well as contribute to the biostatistics analysis plan, and clinical study reports (CSRs) along with biostatistics and other R&D colleagues
Drive clinical development components in the writing and data interpretation of CSRs and oversee filing and registration activities
Review, interpret and present clinical data to internal and external stakeholders
Provide adequate oversight and mentoring of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documents
Lead the evidence generation strategy as well as contribute to content of individual publications, abstracts, and presentations
Maintain up-to-date knowledge of scientific and clinical published literature
Interact with KOLs to assure implementation of latest clinical thinking and guidelines into the integrated product development plan
Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, and consultants
Provide input/review study start up documentation, e.g., CRF design
Attend and provide clinical support for investigator and steering committee meetings
Participate in due diligence and business development activities as needed
Always operate within Compliance Guidelines
Provide medical monitoring oversight for clinical trials as required
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.
Basic Qualifications
MD or DO from an accredited medical school AND
Five (5) years of industry or academic research AND
Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
PhD, MBBS plus accredited residency in relevant sub-specialty, board certified or equivalent
Ten (10) or more years in biopharmaceutical sponsored clinical research is desirable
Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable
Solid understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology approaches
Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
Ability to analyze and interpret complex datasets
Exercises initiative in meeting goals and drives innovation in projects
They will also embody the Amgen leadership attributes which are:
Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection
Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being.
From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The annual base salary range for this opportunity in the U.S. is $343,334 - $403,728.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
.
Salary Range
343,334.00 USD - 403,728.00 USD
Auto-ApplyExecutive Director, Medical Engagement & Scientific Communications Strategy
Thousand Oaks, CA jobs
Career CategoryScientificJob Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year.
As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Executive Director, Medical Engagement & Scientific Communications Strategy
What you will do
Let's do this. Let's change the world. In this vital role as the Executive Director (ED), Medical Engagement & Scientific Communications Strategy you will serve as a visionary leader responsible for transforming how Amgen engages with healthcare professionals (HCPs) and communicates scientific information globally.
This individual will be responsible for evolving the cross functional operating model that brings together Field Medical, Scientific Communications, analytics, and digital capabilities into a single, customer-centric engagement model, ensuring Amgen's science reaches the right stakeholders, in the right channels, with suitable content to drive measurable impact.
This leader will also be responsible for shaping the vision and providing strategic guidance on technology and digital solutions, serving as a trusted thought partner to the organization.
Reporting to the Global Medical VP, this high-impact position is accountable for Amgen's Global Medical Affairs customer engagement and digital strategy and planning and is instrumental in shaping the strategic narrative of our prioritized innovative pipeline and marketed products across our Therapeutic Areas (General Medicines, Obesity, Inflammation, Oncology, Rare Disease).
As part of this role, you will lead the creation and orchestration of multi-channel engagement strategies that elevate scientific understanding and patient care and drive the digital and technology roadmap to enable and support these strategies.
Key Responsibilities
Strategic Leadership
Develop and lead an enterprise-wide medical engagement and communications strategy aligned with Amgen's scientific and clinical objectives.
Define and implement a modern, HCP/customer-centric operating model that integrates content, channels, analytics, and field engagement.
Define the digital initiatives and technology solutions that address our most pressing pain points and unmet needs, to support HCP engagement while enabling operational efficiency.
Serve as a thought partner and advisor to Therapeutic Area and regional leadership, guiding insight-driven and impact-oriented engagement plans.
Scientific Communications Leadership
Direct the Scientific Communications team across Amgen's therapeutic portfolio (marketed and pipeline products).
Drive development of integrated scientific communication plans for global and U.S. prioritized assets.
Oversee content strategy for publications, congresses, medical education, and digital platforms.
Partner with internal and external stakeholders to ensure effective, scientifically sound execution of Amgen's medical content at symposia and congresses.
Partner with the Amgen India Scientific Communications Head to translate scientific communications strategies and plans into actionable assets (publications, Global Medical content, payer-relevant content) and drive execution of plans with measurable impact.
Innovate and simplify complex data into compelling narratives that resonate with HCPs and other stakeholders in the U.S and other strategic markets for prioritized assets.
Advance the function's capabilities in digital and multichannel communications in compliance with Good Publication Practices and external standards.
Ensure compliance with relevant Scientific Communications SOPs and systems, and evolve procedures to meet regulatory, legal, and industry guidelines.
Multichannel Engagement Operations
Align Field Medical and Scientific Communications around unified workflows, automation, and modular content reuse.
Establish and evolve tools for HCP segmentation, audience insights, measurement frameworks, and channel orchestration, especially related to digital channels.
Maximize the discoverability and utility of Amgen's scientific content across owned and relevant third-party platforms.
Expand reach beyond traditional tactics, embracing digital innovation to amplify scientific impact.
Partner with Amgen's Global Commercial Capabilities team to build an integrated omnichannel platform across functions.
Capability Building & Change Enablement
Drive capability development across communications channel strategy & planning, publication strategy, digital engagement, and the use of technology and data to deliver content and experiences to HCPs.
Partner with internal stakeholders (e.g., Medical Directors, Field Medical, Commercial Leadership, Technology, Analytics) to define and implement HCP engagement strategies, capabilities and solutions including profiling/targeting, channel orchestration, and impact measurement.
Cultivate a high-performing culture focused on innovation, excellence, and delivering meaningful impact to patients and clinicians.
Responsible for continuous learning, best practices sharing, talent development, and performance management for the Medical Engagement & Scientific Communications team.
Mentor, inspire, and manage a diverse team of scientific communication specialists, ensuring effective talent management and succession planning.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The executive we seek is an experienced leader with the following qualifications.
Basic Qualifications:
Doctorate degree & 6 years of directly related experience OR
Master's degree & 10 years of directly related experience OR
Bachelor's degree & 12 years of directly related experience AND
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
Advanced degree in a life science discipline (PhD, PharmD, MD)
Extensive leadership experience in Scientific Communications (including publication strategy) and Medical Affairs within the biopharmaceutical industry
Prior experience in therapeutic areas such as cardiovascular, metabolism, bone, oncology, rare diseases and inflammation.
Proven success in building omnichannel strategies and digital engagement capabilities at a pharma company or at a digital agency primarily or exclusively serving pharma companies.
Artificial Intelligence literacy and digital fluency.
Deep knowledge of regulatory and compliance requirements in pharmaceutical communications
Financial and operational management expertise
Demonstrated ability to operate in a matrixed environment, lead through change, manage complexity, and influence cross-functional stakeholders
Strong verbal and written communication skills, executive presence, and stakeholder engagement expertise
Recognized expert in scientific communications, publications, and medical engagement practices
They will also embody the Amgen leadership attributes which are:
Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection
Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The annual base salary range for this opportunity in the U.S. is $278,474 - $326,024.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
.
Salary Range
278,474.00 USD - 326,024.00 USD
Auto-ApplyExecutive Director, Clinical Development Program Lead (Neuropsychiatry)
San Diego, CA jobs
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
Position Summary
The Clinical Development Program Leader sits within Clinical Development, which is a global organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.
* The Clinical Development Program Leader will set the clinical development strategy for assets or indications
* The Clinical Development Program Leader will directly supervise the work of multiple Clinical Development Leads who will in turn supervise individual Clinical Trial Physicians unless otherwise indicated
* This role will include above disease / indication strategy work (i.e. supervising Broad Clinical Development teams across several Development teams, as well as Disease / Indication Strategy teams etc.)
* The role will be foundational in working with teams in R & ED and GDD to support GT4/5 and POC transitions, providing insights into biology, translational elements as well as overall benefit risk assessments
* The role will supervise the development of differentiated and strategic Clinical Development Physicians (CDPs) for multiple transition assets and support a broad program of work from phase I expansion through to registrational execution
* The role includes support of across portfolio activities in line with Clinical Excellence, including e.g. Protocol Review Committee, support of Business Development activities and Quality and Compliance leadership
* The role will report directly to the Head of Clinical Development and will deputize as required, and will be a core member of the Therapeutic Area clinical development executive leadership team
Key Responsibilities
Strategy and Execution
* Create and communicate a vision for designing, conducting and executing innovative clinical development plans
* This leader will supervise the development, monitoring, analysis and interpretation of clinical trials and will supervise and have accountability for the clinical components of regulatory filings
* Will contribute to overall strategy for specific disease / indications while ensuring a franchise overall portfolio view
* Provide strategic insights into the clinical development plans
* Lead search and evaluation activities on business development due diligence efforts, and advice to our strategic transactions group
* Key Member of Therapeutic Area Clinical Development Leadership Team and chairing forum as required
* Chair departmental Staff Meetings and represent governance meetings on an ad hoc basis
* Will build a franchise reputation that attracts innovators to bring their ideas to BMS
Drug Development Experience
* Will create a Clinical Development strategy to develop programs beyond commercialization and launch and into lifecycle management
Leadership and Matrix Management
* Lead and develop a group of Clinical Development professionals (team of up to 50 individuals both direct and indirect) whose therapeutic area focus is in a specific disease area / indication and will ensure scientific and technical excellence of clinical development programs and deliverables
* This individual will recruit, develop and retain strong talent
* Mentoring of talent/staff
* Will establish an effective and ethical culture that encourages teamwork, peer review, promotes cooperation and provides a supportive culture
* Will be responsible for developing a culture that values diversity of thought, supports coaching, fosters accountability and integrity, and supports process excellence and continuous improvement
* Will be responsible for oversight of team budget and headcount
Stakeholder Engagement and Communication
* Will work closely with colleagues in BMS Research, Development, Regulatory, Medical, Commercial and other key functional areas on a global basis; additionally should have an external focus and build relationships with thought leaders, physicians, and patient advocacy groups outside of BMS. Be recognized internally and externally as an expert in the field
* Partner and interact with colleagues from Research and Early Development who design and implement first in human through proof of concept trials and will assure a seamless transition into late stage development (Phase II-III trials.)
Governance Participation and Signature Authority
* Governance participation ad hoc as designated
* PRC Chair ad hoc as needed
* Signature Authority for:
* CSRs
* Health Authority Briefings
* DMC Charters
* Unblinding Requests
* Health Authority Documents for Filings
* And other clinical accountable documents delegated as needed
Qualifications & Experience
* MD (PhD or other high level degree optional)
Experience Requirements:
* The ideal candidate will be a clinical development leader; with greater than 10 years of extensive clinical trial, drug development, and regulatory experience, in addition to a strong scientific background
* Management experience will be important since this individual will manage a group of professionals including MDs or PhDs or PharmDs with clinical research experience.
* The successful candidate will understand early-stage drug development, extensive experience designing and conducting Phase I, II and Phase III clinical trials, and should have demonstrable success filing regulatory dossiers and prosecuting them through approval
* Global experiences is a plus since this position has responsibility for strategy and clinical research in oncology in multiple geographies
* Experience interacting with business development and licensing, particularly helping to evaluate the technical and franchise aspects for potential in-licensing opportunities that shape the oncology clinical development strategy
Key Competency Requirements:
* Proven track record in managing complex clinical programs leading to regulatory submissions
* Deep understanding of Biology, targets and translational science
* Extensive experience of work with health authorities at all levels
* Proven differentiated ability to support and manage across the totality of the spectrum including development of registrational and non-registrational trials
* Proven ability to execute the BMS R&D People Strategy, and lead and develop a matrix team
* The candidate also must be a highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory
* The candidate must be comfortable with cross-functional drug and product development teams and managing in a matrix environment
* In addition, the candidate must be skilled at interacting externally, and at speaking engagements
* Must be skilled at attracting, developing, and retaining skilled professionals
Travel Required
* Domestic and International travel may be required.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Compensation Overview:
$340,870 - $413,051
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit *************************************
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: *********************************************
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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Who We Are / Background BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
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