Adverum Biotechnologies jobs

Senior Corporate Counsel, Contracts page is loaded## Senior Corporate Counsel, Contractslocations: Alameda, CAtime type: Full timeposted on: Posted Todayjob requisition id: JR6460**SUMMARY/JOB PURPOSE:**The Senior Corporate Counsel, Contracts takes a supporting role in setting the material terms of the many business transactions undertaken by the company, the drafting and negotiation of definitive and ancillary agreements reflecting those terms, and the organization of processes necessary and helpful for Exelixis to transact efficiently and effectively. This function also plays a transactional oversight role, working with Legal and operational colleagues to help ensure that the company's R&D activities and transactions are carried out with efficiency and reflect an appreciation for an appropriate level of business and legal risk.**ESSENTIAL DUTIES AND RESPONSIBILITIES:*** Drafts, reviews, and negotiates a wide range of contracts with a very high degree of independence in support of the Research and Development organizations (which may include confidentiality agreements, collaboration agreements, licensing agreements, consulting agreements, materials transfer agreements, simple and complex clinical trial agreements, clinical advisory board agreements, and various vendor services agreements, and manufacturing agreements for cGMP drug supply).* Acts as a legal point person for ongoing agreements in support of R&D efforts.* Reviews redlines, supervises negotiations and provides general guidance to junior attorneys and contracts managers.* Assists with maintaining up-to-date form agreements consistent with industry standards and applicable laws.* Identifies and defines operational and legal risks and is able to communicate those risks to appropriate internal decision-makers for discussion and resolution.* Cultivates strong and highly effective cross-functional relationships and communication with internal colleagues to effectively address legal and business questions.* Effectively represents the company.* Handles miscellaneous legal tasks on an as-needed basis.**SUPERVISORY RESPONSIBILITIES:*** No supervisory responsibilities but may provide direction to other individuals.**EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:****Education:*** BS/BA degree, preferably in life sciences or a related field; an advanced life science degree is preferred.* JD degree is required and a minimum of six to eight years of relevant experience.* Must be admitted to practice law, preferably in California.**Experience:*** Experience as an attorney in a law firm or in-house legal environment in biotechnology or pharmaceutical industry.* Complex contract drafting and negotiation experience required, including a significant volume of contracts in support of drug Research & Development activities.**Knowledge/Skills:*** Possesses clear and concise verbal and written communication skills and must have excellent interpersonal communication skills.* Strong computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint, etc.), document management systems, and redlining software).* Must be detail-oriented and have strong organizational skills.* Ability to handle multiple tasks simultaneously, with the ability to re-prioritize on short time frames. Can quickly separate the mission-critical from the nice-to-haves and the trivial.* Ability to make complex decisions based on the data available; drives to the finish on all projects.* Acts responsibly and conscientiously.* Works under pressure to meet specific deadlines.* Works well both independently and in a team environment; addresses differences fairly and equitably; treats everyone as a preferred internal client.* Dedicated to quality, reliability, and highest professional standards in all work tasks.* Must be a self-starter and quick learner.* Must have good judgment.**WORKING CONDITIONS:*** Primarily working indoors, in an office environment#LI-HG1*If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!*### ### Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $222,000 - $316,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.### **DISCLAIMER** The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.***We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.***Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too. #J-18808-Ljbffr

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 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. Associate Director, Manufacturing Operational Readiness Gilead Sciences is seeking a highly motivated, adaptable, and experienced Program and Project Management leader to start up a new state-of-the-art Single-Use DS Biologics Manufacturing facility in Foster City and integrate this facility with existing Foster City cGMP Manufacturing activities. As the Foster City Manufacturing Operational Readiness Program Lead, you will design, build and manage the multi-year cross-functional program of activities and workstreams involved in transitioning Gilead's new Foster City biologics manufacturing facility from capital project into routine cGMP production. You will help ensure that the systems, people, and processes are in place to support clinical manufacturing and future commercial launches. This is a unique opportunity to shape the future of Foster City Manufacturing for Gilead and make a lasting impact on global health. Job Responsibilities Coordinate the creation of an Operational Readiness Program and reinforce a sense of purpose and ownership among all team members. Structure distribution of responsibilities across multiple workstreams within the program, drive prioritization and sequencing of workstreams, and partner with the Capital Project team to align operational and project timelines, deliverables, and resources. Evaluate industry best practices and select an appropriate program and project delivery model that supports the dynamic nature of a new facility startup and integrates with Gilead's existing governance and delivery frameworks. Select and manage the tools, standards, business processes, documentation, metrics, and communications associated with the Operational Readiness Program. Partner with IT and key stakeholders to pilot and implement innovative digital solutions for the Operational Readiness Program and Foster City Manufacturing. Organize, prioritize, sequence, and track workstreams, activities, and resources necessary for Foster City Manufacturing to support startup and Engineering project deliverables. Work with the Foster City Manufacturing Leadership Team, the Global Manufacturing organization, and senior leaders across PDM to develop a comprehensive Foster City Manufacturing site strategy document and own the portfolio of projects to achieve the site's long-term ambitions. Actively participate in defining and communicating the Foster City Manufacturing mission and vision in alignment with Gilead's corporate values. Act as a change agent to foster an inclusive and high performing organization with a culture of curiosity, continuous improvement, and innovation. Operate with an Enterprise-First mindset and a willingness to adapt and flex across functional boundaries as needed to achieve mission critical tasks. Minimum Required Education, Years of Experience and Qualifications Bachelor's degree in engineering, life sciences, or related field. and 10+ years of experience in biotech/pharma manufacturing or process development with a minimum of 2 years direct or matrixed people leadership experience. OR Masters' Degree and Eight Years' Experience in biotech/pharma manufacturing or process development with direct or matrixed people leadership experience 5+ years of project and portfolio management experience utilizing both traditional and agile project delivery methodologies. Strong understanding of cGMP compliance. Strong business and financial acumen. Proven experience successfully managing cross-functional teams and complex project timelines with significant components of uncertainty. Demonstrated ability to thrive in a dynamic environment and collaborate across diverse technical areas. Experience with Biologics Drug Substance manufacturing equipment and processes, Single-Use Technologies, and cGMP facility qualification and startup preferred. The salary range for this position is: $195,670.00 - $253,220.00. 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.

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** Patient Safety is seeking a dynamic and experienced individual to join the **Patient Safety Strategic Operations** team as an **Associate Director, Patient Safety Medical Device Safety** responsible for supporting activities to ensure ongoing safety oversight of Gilead's medical devices and combination products throughout the product lifecycle. These activities include but are not limited to ensuring compliant global processes for vigilance/safety reporting, post-market surveillance system, trending of device complaints, risk management, and analysis of safety data sets covering Gilead medical device and combination product portfolio. This role will help drive strategies and ensure operational excellence through successful business partner collaboration. The Associate Director, PS Medical Device Safety will be a medical device / combination product expert who supports safety oversight and provides technical contributions to design control, risk management, clinical evaluations, vigilance/safety reporting, post-market surveillance and trending / signal management for medical devices and combination products worldwide. The role would suit someone with passion for patient safety, strong strategic thinking, communication and analytical skills, broad PV and medical device / combination product experience and an enthusiasm for understanding the business needs. **Key Responsibilities** Responsibilities include, but are not limited to: + Ensure safety processes are executed and maintained throughout the product lifecycle in compliance with relevant regulations, standards, and guidelines for medical devices, combination products and diagnostics. + Review device cases / complaints to ensure that case processing and evaluation are accurate and in compliance with regulatory requirements for safety reporting and Gilead standards. Closely collaborate with ICSR and Product Complaint teams to resolve any issues, inconsistencies or inaccuracies identified between the Global Safety database and Quality database. + Develop training and standards for case processing and safety reporting. + Contribute to medical device / combination product Post-Market Surveillance (PMS), including planning and report preparation. Support writing, review, and submission of applicable device contribution in aggregate reports (PSUR/PBRER, PADER). + Collaborate with PS Therapeutic Area leads and PS Benefit-Risk Science teams to conduct safety assessments of data sets including device complaints, as well as device trending and signal management for combination products. + Provide device safety contribution and collaborate with PS Therapeutic Area leads in combination product development and clinical studies. + Collaborate with cross-functional team in device risk management activities including identification and reduction of risks associated with Gilead's medical devices / combination products, conducting benefit-risk analysis, and evaluating overall residual risk acceptability throughout the lifecycle of the product. + Review regulatory intelligence and work with PS cross functional team to interpret, assess impact, and update processes and procedures with regards to device / combination product regulations requirements and updates as required. + Collaborate with PS Affiliate leads regarding local regulatory requirements and coordinate globally. + Represent PS in cross functional working groups and teams with regards to device / combination product / diagnostic regulations and its impact to PS. + Link with PS Alliances team regarding device requirements needed in PV agreements with License Partners. + Collaborate with cross-functional teams in the preparation and/or support of internal audits and regulatory agency inspections; reviews, responds and implement corrective and preventive actions with respect to findings on PS processes for medical device / combination product. + Develop solutions to a wide range of complex problems, ensuring solutions are consistent with organization objectives. + Foster a culture of collaboration and communication to drive business objectives. + Drive a culture of continuous improvement to enhance PS processes and safety oversight. + Stay abreast of industry trends, emerging topics, and best practices in the medical device / combination product space. **Basic Qualifications** + BA/BS with 10+ years' relevant experience OR + MA/MS/MBA with 8+ years' relevant experience OR + PhD/PharmD with 5+ years' relevant experience **Preferred Qualifications** + Health care professional degree preferably Nursing or Biomedical Engineering degree. + Extensive medical device / combination product safety or related experience. Previous experience in pharmacovigilance and device safety activities. + Thorough understanding and application of medical device / combination product regulations and industry standards globally for design control, device risk management, vigilance / safety reporting, and post-market surveillance throughout the product lifecycle. Experience translating these requirements into medical device safety processes, in particular risk management, device vigilance / safety reporting and post-market surveillance preferred. + Significant experience in navigating a matrix organization. + Track record of successfully leading complex, large scale, time-sensitive projects. + Strong relationship building skills, and ability to collaborate, influence and negotiate to work effectively with cross-functional teams to meet project timelines and patient needs. + Excellent verbal, written, and interpersonal communication skills. Ability to write clear and concise documents/presentations. + Ability to prioritize and manage across multiple competing projects. + When needed, ability to travel. The salary range for this position is: Other US Locations: $177,905.00 - $230,230.00. Bay Area: $195,670.00 - $253,220.00. 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.

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 is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North, South and Central America, Europe, Africa, Asia and Australia. Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic status. Gilead Sciences is currently seeking a Quality Site Lead (QSL) to provide quality oversight of GMP activities at assigned Gilead CXOs, supporting the manufacture of Biologics intermediates, drug substances and drug products for clinical and commercial distribution. This role is needed to ensure Gilead's CXOs are proactively managed from a quality and compliance perspective. Job Functions: Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned Gilead CXO partners/sites. Assure CXOs meet Gilead's quality, regulatory and compliance standards, to ensure a sustainable delivery of quality products to patients. Key representative on Product Quality Teams for assigned CXO. Ensure contract manufacturers are compliant and ready for regulatory inspections and monitor progress during inspection. Support onsite inspections to ensure compliance and readiness, as needed. Facilitates quality events for CXOs. Partner with internal stakeholders such as Global External Manufacturing, Global Supply Chain, Pharmaceutical Development, and Regulatory Chemistry, Manufacturing and Controls (RA CMC), to identify solutions and processes and align with key partners on implementation of new requirements; proactively address. Lead escalations for critical quality issues. Evaluate current quality systems and processes and recommend and implement appropriate enhancements and trainings to ensure the achievement of Gilead long-term objectives. Monitor CXO site trends, holding CXO accountable to established performance criteria and QAG requirements. Ensure GMP documentation is accurate and compliant with internal and external standards and requirements. Provide guidance to the business teams on regulatory requirements and assist where needed. Participate on CXO Business Review Meetings (BRMs) as Quality's voice for the contract organizations' oversight. Establish and foster meaningful Quality to Quality relationships between Gilead and CXOs. Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion. Partner with Manufacturing, Development, Global Supply Chain, Global QC and Outsourcing to deliver on the production plan. Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations. Champion Quality Risk Management, identifying key risks impacting CXO performance. Accountable for PAI/PLI readiness for assigned CXO sites. Travel to CXO site(s) to provide Quality oversight of critical manufacturing activities, as . Up to 20% travel based on strategic plan. May manage a team of Quality Professionals. Knowledge, Experience and Skills: Knowledgeable in quality requirements pertaining to manufacturing, testing, packaging, labeling, facility, utility, equipment and process validation, cleanroom classification and qualification, new product introduction, multi-product facility control, contamination control strategy, technology transfer, contract operations, product release, disposition, and distribution. In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally. Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. Knowledgeable in Global requirement/standards for product registration and life cycle management of product quality. Demonstrated ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist. Excellent verbal, written, and interpersonal communication skills. Experienced in prioritizing workload to address competing projects and timelines. Basic Qualifications: 8+ years of relevant experience and a bachelor's degree in science or related fields; or 6+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA. Knowledge in technical and regulatory requirements pertaining to manufacturing, product lifecycle management, and outsourced operations a must. Biopharmaceutical or Pharmaceutical experience a must. Prior experience leading contract manufacturing/testing operations or overseeing contract manufacturing operations a must. Experience with different pharmaceutical modalities, e.g., active pharmaceutical ingredients, parenteral, biologics, and medical device preferred. The salary range for this position is: $157,590.00 - $203,940.00. 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.

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 We are seeking a highly talented and motivated Senior Oncology Bioinformatics Scientist to take a lead role in statistical analysis of multi-omics and next generation sequencing data to support research projects from target evaluation to biomarker discovery with a focus in immune oncology and cancer biology. The successful candidate will have the chance to work in a fast-paced and highly collaborative environment and impact high-level decision-making on internal pipeline and external collaboration. The scientist will be responsible for developing and employing rigorous statistical modeling and cutting-edge bioinformatics methods to perform integrative large scale omics dataset analysis to enable research objectives. The successful candidate will be able to formulate scientific questions into coherent analytical efforts and communicate analysis results and scientific findings to project teams and across different research functions. Essential Functions: Develop and apply statistical and computational tools to analyze large scale omics and high dimensional data from internal, publicly available, commercial, and real-world datasets to enable novel target identification, target assessment, MoA elucidation, drug combination rationale, and patient stratification, etc. Design and apply statistical techniques and machine learning algorithms to enable the discovery and evaluation of preclinical predictive and prognostic biomarkers for oncology projects. Collaborate with cross-functional teams to analyze and interpret complex large datasets and efficiently communicate findings to non-computational scientists and senior leaders. Minimum Knowledge, Experience, and Skills: Extensive hands-on experience in analyzing and interpreting RNA-Seq (bulk and single cell), WES, WGS, ATAC-Seq, CITE-Seq, and TCR-Seq data is required. The experience in analyzing other omics data (e.g., spatial transcriptome, Chip-Seq, MeRIP-seq, NanoString, multiplex qPCR, HT screening data sets) is a plus. Strong statistics knowledge, such as probability theory, univariate and multi-variable analysis, unsupervised and supervised analysis, regression analysis, survival analysis, feature selection, and power analysis. Excellent oral and written communication skills. Demonstrated capability to synthesize scientific questions into a coherent research effort and efficiently communicate scientific findings across different functional teams and present analysis results to project review teams and senior leader committees. A proactive and self-motivated scientist with a strong work ethic and scientific rigor; ability to work in a dynamic environment and manage multiple projects in parallel and adapt to changing priorities. Demonstrated track record of producing high-quality scientific results as an individual contributor and a team member. Basic Qualifications: Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR Ph.D. Preferred Qualifications: A PhD in bioinformatics, computational biology, biostatics, cancer genomics, or a related field with at least 3 years of relevant work experience. Industry experience is preferred. Excellent interpersonal and communication skills that foster collaboration and teamwork. Basic understanding of cancer biology, immunology, molecular and cell biology. Proficiency in R, Python, Perl, JAVA, or C/C++ programming languages. Proficiency in high performance computing and cloud computing environments. Outstanding track record of scientific and technical proficiency, evidenced by high quality publications in peer-reviewed journals. Able to work on-site at our Foster City Headquarters at least 3 days per week. 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: $169,320.00 - $219,120.00. 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.

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 The Senior Specialist, Sustainability Engagement Program, will be a key driver of Gilead's internal sustainability culture. This role is focused on engaging our global workforce, embedding sustainable practices into our daily operations, and communicating our environmental initiatives effectively across the company. You will be responsible for coordinating employee-led green initiatives, developing programs for sustainable corporate events and travel, and creating compelling content to educate and inspire our colleagues. Essential Duties and Job Functions Employee Engagement: Develop and coordinate company-wide sustainability engagement campaigns and events. Act as the primary liaison and operational leader for Gilead's internal "Green Team" network, empowering employee champions to drive local initiatives. Internal Communications: Create and manage a consistent pipeline of internal communications to build awareness and educate employees on our sustainability strategy, goals, and achievements. This includes writing articles, producing stories, and creating presentations. Digital Content Management: Administer and refresh content for internal sustainability web pages, SharePoint sites, and other digital channels to ensure information is current, engaging, and easily accessible to all employees. Sustainable Events: Partner with Corporate Travel, Meetings & Events, and Facilities teams to develop and execute strategies for more sustainable corporate travel, meetings, and on-site events. Program Management: Support the broader sustainability team by coordinating projects, tracking key performance indicators for engagement programs, and gathering feedback to continuously improve and communicate on our initiatives. Cross-Functional Collaboration: Work closely with key stakeholders to align sustainability engagement with broader company culture and communications efforts. Knowledge, Experience and Skills Essential: 5+ years of relevant experience with a Bachelor's degree in Communications, Marketing, Environmental Studies, Sustainability, Business, or a related field OR 3+ years of relevant experience with a Master's degree. Demonstrated experience in developing and executing employee engagement or internal communications campaigns. Excellent written and verbal communication skills, with a proven ability to craft clear, compelling, and accessible content for a diverse corporate audience. Experience managing digital content and platforms (e.g., intranet, SharePoint, or similar). Strong organizational and project management skills, with the ability to manage multiple projects simultaneously. A passion for sustainability and the ability to translate complex environmental topics into relatable and actionable initiatives. Proven ability to build relationships and collaborate effectively across different teams and functions. Desirable: Experience in a corporate sustainability or corporate social responsibility (CSR) role is a plus. Experience with event planning or developing sustainable procurement guidelines. Familiarity with graphic design or video production tools for creating engaging content. Experience working within a global, matrixed organization. The salary range for this position is: $126,820.00 - $164,120.00. 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.

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** As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company's mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. **Key Responsibilities will include, but are not limited to the following:** + Work with plant operations team to understand solid oral dose manufacturing, current 3D printing applications and potentially identify new use cases + Use SolidWorks to create/modify 3D printed fixtures and components + Investigate material properties and technical specifications for various filaments, resins and post-processing agents + Assess potential risks and document in qualification roadmap + Showcase your work with a final presentation (PPT) near the conclusion of your internship **Required Qualifications:** + Must be at least 18 years old + Must have a minimum GPA of 2.8 + Authorized to work in the United States without Sponsorship now or in the future. + Must be currently enrolled as a full-time student in a Bachelor's/Master's at an accredited US based university or college + Must be a Rising Sophomore, Junior, or Senior in undergrad + Must be enrolled full-time in the Fall Semester at an accredited university/college after the completion of the internship + Must be able to complete a 10-12 consecutive week internship between May and August + Must be able to relocate and work at the designated site for the duration of the internship **Preferred Qualifications** **:** + Preferred Degree qualification: **Undergrad** + Proficiency with SolidWorks and basic slicing programs + **Understanding of how to set up, calibrate and maintain 3D printers (FDM, SLA, SLS)** + Proficiency with MS Office Suite + Ability to identify issues and seek solutions + Ability to work both independently and collaboratively + Demonstrated commitment to inclusion and diversity in the workplace + Efficient, organized, and able to handle short timelines in a fast-paced environment **Gilead Core Values:** + Integrity (Doing What's Right) + Inclusion (Encouraging Diversity) + Teamwork (Working Together) + Excellence (Being Your Best) + Accountability (Taking Personal Responsibility) The expected hourly range for this position is $19.00 - $55.00. Gilead considers a variety of factors when determining base compensation, including education level and geographic location. These considerations mean actual compensation will vary. Benefits include paid company holidays, sick time, and housing stipends for eligible employees. **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.

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 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. Qualified candidates will focus on the development of devices and drug-device combination products such as pre-filled syringes and auto-injectors. Specific Job Responsibilities Lead or support human factors engineering (HFE) strategies and HFE activities for device combination product design and development from feasibility, clinical development, through registration, and post-market. This includes requirements definition, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies. Author HFE deliverables for device design history files and HFE sections for health authority submissions and written responses. Educate team members and other internal stakeholders on the HFE development process and approach. Interface and coordinate with HFE consulting firms to execute human factors engineering activities. Improve internal HFE processes at Gilead to ensure consistency, compliance, and efficiency. Ensure all HFE work is performed in accordance with SOPs and applicable regulatory requirements. Required Education: B.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 8+ years of relevant experience OR M.S. degree in mechanical engineering, chemical engineering, bioengineering, or a related scientific field with 6+ years of relevant experience. Experience & Skills: Experience with leading HFE efforts in support of combination product development and commercialization, including a working knowledge of human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combination products. Excellent verbal, written, and interpersonal communication skills are required. Demonstrated ability to facilitate the interface with medical device vendors and HF consulting firms. Demonstrated ability to analyze data and identify relevant design updates. Must be able to write clear, concise, high-quality documents. Must be able to exercise judgment within areas of ambiguity as well as established procedures and policies in order to determine and take appropriate action. Experience managing team expectations for project timelines, including realistic timeline estimates for HFE activities. A deep knowledge of the regulatory and compliance requirements for HFE and combination product risk management. Ability to effectively collaborate with cross-functional teams and influence key stakeholders. The salary range for this position is: $157,590.00 - $203,940.00. 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.

SUMMARY/JOB PURPOSE: Scientific Publications is a group within Medical Affairs with responsibility for development of scientific publications and publication planning. The Associate Scientific Publications Director plans publication strategy and works to develop, coordinate and execute publications tactics. This includes developing robust publication plans, and managing development of scientific presentations, and publications. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Operate in accordance with all Exelixis SOPs, including the Publications SOP, and promote the adoption of working standards consistent with Good Publication Practice. * Contribute to strategic, operational and tactical planning for the Exelixis Publication Plan. * May write and revise abstracts, posters, case reports, and manuscripts for submission to scientific congresses or peer reviewed journals. * Work with publications and writing vendors as needed. * Coordinate with internal and external stakeholders; ensure execution of abstracts, posters, oral presentations and manuscripts in accordance with timelines as set in the publication plan. * Use the Datavision publications portal to monitor feedback on publications * Collaborate with other members of the Medical Affairs organization (e.g. Medical Science Liaisons, Medical Information, Medical Research, etc) in support of their functional area deliverables. * Attend scientific conferences to enhance therapeutic knowledge and to contribute to execution of Medical Affairs conference deliverables. * Develop product and disease state expertise, keep abreast of the changing drug development environment. * Other duties and responsibilities as assigned. SUPERVISORY RESPONSIBILITIES: * None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: * Bachelor's level degree in related discipline and a minimum of eleven years of related experience; or, * Master's level degree in related discipline and a minimum of nine years of related experience; or, * Doctorate level degree (PharmD, MD, PhD) and a minimum of five years of related experience; or, * Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: * Oncology experience preferred. * Experience in pharmaceutical/biotech desirable. * Significant experience with publication development and writing is required. * Understanding of clinical trial design, interpretation of scientific data and communication via clinical and medical affairs channels, preferred. Knowledge/Skills: * Excellent organizational, time, and project management skills. * Skilled medical/technical writer with attention to detail. * Self-motivated, organized, problem-solving, solution-oriented, collaborative team player. * Strong skills with regard to written and verbal communication of complex medical and scientific data to a variety of audiences. * Strong interpersonal and collaboration competencies for interfacing with a wide range of internal and external cross-functional partners. * Ability to foster relationships, build alignment, negotiate, and collaborate with internal and external stakeholders. * Ability to work independently and manage multiple projects in a fast-paced and dynamic environment. JOB COMPLEXITY: * Works in a fast-paced, small-team environment that is growing and evolving. This position requires regular reprioritization of projects while adhering to timelines and achievement of deliverables. WORKING CONDITIONS: * Occasional travel required to support medical affairs activities at scientific congresses and company meetings. #LI-MB1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $158,000 - $224,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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 Position Overview: We are seeking a highly motivated and creative Research Scientist to join the Discovery Sciences and Technologies (DST) Department and contribute to our biophysics capabilities to enable the identification and nomination of small molecule and biologics drug candidates across all therapeutic areas at Gilead. DST Department members are responsible for the design and execution of rigorous, quantitative, in vitro biochemical, biophysical, and functional cellular assays. They collaborate within multi-disciplinary teams to discover and evolve drug candidates from lead identification efforts during project inception to the characterization of the final development candidate. The successful candidate will be an integral member of the DST research team and work closely with various Research functions such as medicinal chemistry, structural biology, and protein therapeutics to advance transformational therapies into clinical development for patients. Gilead is a highly matrixed organization and the ability to work effectively across diverse functional groups and therapeutic areas is a key attribute for this role. Specific Responsibilities: Apply steady-state and pre-steady-state kinetic assays to characterize enzyme targets and inhibitor mechanism of action Experience with mass spectrometry-based and biosensor approaches for lead ID characterization of novel and traditional drug modalities including PROTACs, molecular glues and covalent inhibitors Strong technical background in cellular assay development and signaling pathways Must be both a critical and creative thinker and be able to apply an advanced level of understanding and analytical skills to interpret data and draw conclusions within the broader context of project goals Able to troubleshoot and optimize assays as needed, identifying, and applying novel techniques or proactively seeking out solutions Perform critical experiments to enable hit identification and lead optimization across therapeutic modalities Provide scientific insight and in-depth data interpretation to inform decision making at the project team and leadership levels Evaluate and implement new technologies to support advancement of internal programs and core group functions Contribute to several projects at any given time, work successfully in a cross-functional team environment, and communicate clearly both verbally and in writing to a variety of audiences Basic Qualifications: Bachelor's Degree and 6 years experience OR Master's Degree and 4 years experience OR PhD /PharmD Preferred Qualifications: Ph.D. with a minimum of 2 years of experience, or an M.Sc. with 5-7 years of experience in in biochemistry, enzymology, biophysics or a related scientific discipline and direct experience in assay development and/or inhibitor mechanism of action studies. Background in classical enzymology and biophysics (SPR ITC, MST, KinExA), including steady-state and pre-steady-state kinetics, thermodynamics, and reaction mechanism Expertise in a broad range of assay formats including activity assays, competitive binding assays, and direct binding assays to identify and characterize small molecules and biologics. Practical experience applying mass spec approaches for drug discovery and experience studying covalent and degrader small molecule modalities would be advantageous. Strong analytical skills and a solid understanding of rate equations and data fitting statistics Excellent verbal and written communication skills to disseminate information to direct colleagues and broad audiences Track record of productivity in diverse work environments The candidate should be able to think critically and creatively across multiple disciplines and have demonstrated the ability to answer complex scientific questions using a variety of biophysical techniques e.g. mass spectrometry Experience with automation is a definite plus Must be detail-orientated and extremely well-organized Strong interpersonal and communication skills, with enthusiasm for working in a driven environment characterized by rigorous scientific and innovative thinking Excellent written and oral organizational skills The salary range for this position is: $146,540.00 - $189,640.00. 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.

SUMMARY/JOB PURPOSE: Provide Regulatory Affairs CMC expertise and leadership for global commercial and development projects. Develop strategic approaches to enable succesful Health Authority submissions and communications. Work closely with the Pharmaceutical Operations and Supply Chain (PSC) organization, Quality groups, and cross-functional project teams on the CMC content for global applications (INDs, IMPDs, NDAs, BLAs, MAAs). ESSENTIAL DUTIES/RESPONSIBILITIES: Provide regulatory strategies, appropriate for the stage of product development, to PSC designed to maximize chances of successful and expedient registration with appropriate levels of CMC efficiency and flexibility. Critically review CMC-related submissions to Health Authorities and provide regulatory guidance to PSC. Ensure submissions to regulatory Health Authorities are complete, of high quality, and compliant with applicable regional regulations while enabling appropriate CMC flexibility. Work with teams to develop responses to review questions from FDA and other regulatory authorities. Track progress of submission review and approval stages across multiple clinical studies and countries. Lead any required CMC-related meetings with Health Authorities working closely with PSC. Provide briefing book templates, collaborate with PSC on meeting prep sessions, and manage the live meeting with the Health Authority. Track and manage through completion Health Authority facing regulatory actions and commitments throughout the product life cycle. Facilitate transition of core Module 3 documents to regional formats for submission Ex-US. Liaise with other members of the Regulatory Affairs department to coordinate CMC changes with other aspects of the development programs. Maintain regulatory compliance through adherence to change control procedures and completion of regulatory impact assessments. Monitor CMC regulations and guidance to assess relevant changes and implications to current and future development and commercial activities. Contribute to the optimization and implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs and identifying solutions for process optimization and efficiency commensurate with departmental and company growth. People management responsibility and oversight (through direct reports and/or as an individual contributor) of other compliance-related initiatives within Regulatory and cross-functionally. Provide leadership within the Regulatory department, including identifying and managing through completion, departmental and cross-project initiatives and regulatory obligations. Liaise internally with members of Exelixis' functional departments. Liaise externally with vendors, partners, and joint development collaborators. SUPERVISORY RESPONSIBILITIES: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: Bachelor's degree in related discipline and a minimum of thirteen years of related experience; or, Master's degree in related discipline and a minimum of eleven years of related experience; or, PhD degree in related discipline and a minimum of eight years of related experience; or, Equivalent combination of education and experience. Experience: Knowledge, Skills and Abilities: Develops and manages plans, establishes timelines, sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high quality work. Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work. Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one to one situations and effectively presents information to cross-functional groups of colleagues. Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution. Manages effectively performing teams, facilitates team alignment and achievement of common objectives. Engages internal and external stakeholders to establish productive collaborative relationships. Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions. Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives that contribute to departmental goals. Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility. Plans and executes multiple activities. Considers alternative methods and contingency plans to avoid potential issues. Designs and implements solutions to address project level challenges, taking into consideration the broader impact. WORKING CONDITIONS: Travel approximately 15% #LI-MB1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $191,500 - $271,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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. QC Microbiology: The QC Microbiology Senior Scientist is vital role for the success of Clinical and Commercial Biologics and Small Molecule Quality Control. This individual provides support for strategic leadership and oversight of daily microbiological operations. The role will contribute to monitoring QC test method execution and the microbiological lifecycle management. The role is accountable for refining QC procedures across Gilead's small molecule and biologics manufacturing network, ensuring global cGMP compliance. Responsibilities also include managing clinical and commercial microbiological sample shipping and testing logistics and data entry from CTLs/CMOs into Gilead's LIMS. Department: Global Quality Control - GQC-Biologics and Small Molecules Job Responsibilities: * Experience with Small Molecules Quality Control microbiology and extensive knowledge of industry best practices and trends. * In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally. * Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. * Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness. * Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist. * Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions. * Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision. * Demonstrated the ability to influence process and outcomes across functions. * Willing to support future laboratory work. Basic Qualifications: * PhD in Microbiology, Chemistry, Biochemistry or related field with 2+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR * MS in Microbiology, Chemistry, Biochemistry or related field with 6+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR * BS in Microbiology, Chemistry, Biochemistry or related field with 8+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR * Associate's degree in Microbiology, Chemistry, Biochemistry or related field with 10+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring OR * HS degree with 12+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring. Preferred Qualifications: * Preferred 2+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring. * Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting microbiological trends in industry. * Knowledge and experience in Small Molecule Oral Solid Dose and Sterile Small Molecule manufacturing. * Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems. * Strong organizational and planning skills. * Shows excellent verbal and written communication skills and collaborative interpersonal skills. The salary range for this position is: $157,590.00 - $203,940.00. 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.

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 The Associate Director, Strategic Sourcing & Supplier Management, Medical Devices owns the business relationships with suppliers of devices and device related components used with any Gilead branded product. This includes ownership of the strategy, selection, risk, and performance management of suppliers providing devices and device related components for development or commercial products. This role is responsible for both the strategic and tactical business management of these supplier relationships. You will have responsibility for indirectly leading and influencing others, bidding, selecting and managing multiple devices and device related components. This position is based at the Gilead site in Foster City, CA, and is eligible for the Gilead GFlex program allowing remote work up to 2 days per week. Primary Responsibilities: Serve as the primary point of contact for business discussions, long range supply and capacity planning, and business development Management of supplier performance (daily/monthly/annually) Manage the day to day performance of assigned suppliers and serve as an escalation point for issue resolution for other functional areas and both internal and external manufacturing sites. Serve as an escalation point for manufacturing operations team members for recurrent or chronic performance issues with supplier. Lead annual business review meetings (BRMs) with assigned suppliers as needed Lead the assessment and mitigation of supplier risks through regular supplier risk management processes Responsible for preparation, reviewing, challenging, and tracking of RFPs/RFQs/RFIs for new business with external suppliers and in consultation with functional stakeholders (Manufacturing Operations, Technical Development. Quality Assurance, Analytical Operations etc.) Negotiate Confidentiality Agreements, Master Services Agreements and Work Orders In collaboration with Product and Portfolio Strategy team members, identify and manage strategic suppliers of devices and device related components in alignment with network supply chain strategies Identify and manage strategic suppliers of direct materials in alignment with approved Category Management Team (CMT) strategies. Support make vs. buy analysis Lead and participate in Operational Excellence projects. Coordinate/lead meetings internally and with suppliers, publishes meeting minutes. Provide leadership and training to other department personnel Develop budgets and accurately report accruals to Finance if/as needed Participates in solving issues of high complexity. Communicates issues to line manager and project teams in a timely manner Support product team needs for the selection of suppliers to provide required supplies from development through commercialization. Lead and/or support site assessment teams (SATs) in the assessment and selection of suppliers Stay informed and knowledgeable of relevant development and commercial material supplier capabilities, offerings, capacities, etc. as they relate to potential or known Gilead pipeline needs. Establish quality and technical execution expectations with suppliers Collaborate and establish regular meetings with key stakeholders and partners to ensure outsourced needs are met Organize and participate in teleconferences and face-to-face meetings with global suppliers; work closely with Gilead teams to establish agenda and keep track of key decisions Preferred Qualifications: 10+ years of experience in a pharmaceutical/biotech organization or relevant manufacturing environment and a BA or BS degree; an MA/MBA degree may be considered as 2 years of relevant experience and Ph.D. may be consider as 4 years' experience. Prior experience leading outsourced development and manufacturing service providers and/or direct material suppliers Experience working with medical devices. Strong computer skills and experience with an ERP system and project management software Understanding of activities related to the CMC development of biopharmaceuticals Advanced knowledge of GMPs and associated regulations (21CFR parts 11, 210, 211, 820) Ability to lead cross functional teams Strong people management skills Experience negotiating complex agreements Strong verbal and written communication skills Ability to manage multiple programs/projects; sound organizational and time management skills Ability to develop concise presentations to convey complex issues to senior management Ability to work under uncertainty and to resolve conflict in a constructive manner Ability to solve highly complex problems through ingenuity and collaboration with subject matter experts and other key stakeholders Ability to work in a fast-paced environment Project management experience and/or certification are a plus This position may require up to 20% domestic and/or international travel Basic Qualifications: Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD and Two Years' Experience 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: $182,070.00 - $235,620.00. 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.

A leading biotech company based in Alameda, CA, is seeking a Senior Corporate Counsel to manage corporate governance and securities law compliance. The candidate will lead a small legal team, ensuring adherence to SEC and Nasdaq regulations, preparing essential corporate documents, and providing legal support across the organization. Ideal applicants should possess a JD degree, be admitted to practice in California, and have 6-8 years of relevant experience. Competitive compensation and comprehensive benefits included. #J-18808-Ljbffr

SUMMARY/JOB PURPOSE (Basic purpose of the job): Leads content development for various regulatory and clinical documents to support multiple assets across all phases of asset development. Examples include clinical and nonclinical summaries for IND/NDA/BLA/MAA, briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports, and other types of complex cross‑functional documents and reports as needed. ESSENTIAL DUTIES/RESPONSIBILITIES: Independently leads content development for regulatory and clinical documents by composing (writing), developing, reviewing, and editing content. Integrates various sources of information into a uniform style and presentation for the intended audience. Incorporates diverse reviewer feedback while ensuring high quality of content organization, including completeness, clarity, coherence, conciseness, consistency, and accuracy. Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed to create descriptive text and in‑text tables. Assigns and supervises partner regulatory editors for all document tasks unrelated to writing. Proposes and manages timelines for the document development process from initiation through approval. Oversees the assembly of appendices for regulatory submission documents as needed. Serves as the primary writing contact on regular and ad hoc study/program/asset or project teams. Provides writing guidance to internal teams based on organizational goals and company policy, with responsibility for results. Peer reviews project work and training materials/guidelines drafted by Regulatory Science Communications team members. Contributes to SOP and work instruction development and review for the Regulatory Science Communications team. Other duties as needed. SUPERVISORY RESPONSIBILITIES: No direct reports. Supervises work of junior writers and regulatory editors on document tasks. May direct and review the work of contract writers as needed. May mentor less experienced writers. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: BS/BA degree in related discipline and a minimum of eleven years of related experience including industry; or, MS/MA degree in related discipline and a minimum of nine years of related experience including industry; or, PhD in related discipline and a minimum of five years of related experience including industry; or Equivalent combination of education and experience. Active AMWA member with certificate or certification preferred; BELS certification a plus. Experience: Experience in Biotech/Pharmaceutical industry preferred. Prior regulatory/medical/technical writing experience within the biotech, pharmaceutical, or CRO industry. Experience and significant participation in leading content development for regulatory and clinical documents for regulatory submissions (e.g., IND/NDA/BLA/MAAs, clinical protocols, CSRs, IBs). Experience and use of electronic literature tools to obtain scientific/medical abstracts and publications. Familiarity with therapeutic area of oncology. Advanced knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards. Advanced knowledge of AMA style, medical terminology, and clinical data analysis. Knowledge, Skills and Abilities: Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results. Takes pride in delivering high quality work. Applies wide knowledge of the regulatory framework and industry practices to develop innovative approaches and complete complex work. Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to groups of departmental colleagues. Strong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolution. Manages effectively performing teams to achieve common objectives. Engages internal stakeholders to establish productive collaborative relationships. Applies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems. Leads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives. Capable of managing the execution of multiple tasks. Ensures appropriate prioritization and execution for area of responsibility. Proactively anticipates, prioritizes and resolves task-related challenges. Designs and implements solutions to address task-related challenges, taking into consideration the broader impact. Work Environment/Physical Demands: Environment: primarily working indoors. Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. #LI-MB1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $148,500 - $209,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. Gilead is market leader in HIV and seeking an Executive Director, HIV Treatment Marketing Lead to champion the launch of our next groundbreaking HIV therapy-a novel, once-weekly, oral combination of lenacapavir and islatravir. In this leadership role, you'll report directly to the Vice President HIV Treatment and Franchise and lead the strategic preparation and execution of the launch of ISL-LEN to bring this transformative new treatment for people living with HIV. The successful candidate will be a dynamic, experienced individual with a strong track record of commercial success in the pharmaceutical or biopharmaceutical industry. They will provide strong leadership skills with an ability to set a vision and impactful brand strategy, drive innovation and performance within a fast-moving commercial environment. Preferred qualifications include proven success in alliance management, product launches, and experience within the U.S. market. Key Responsibilities: Overseeing the development and implementation of strategic and tactical marketing plans for ISL-LEN and the Long-acting HIV treatment market Successfully managing the partnership with a 3rd party in the US and maintaining close alignment with the ED for HIV Treatment Marketing responsible for QD assets Achieving revenue targets Understanding payer access landscape and partner with managed markets to drive strategy and ensure access and pull-through Managing and leading a team of marketing professionals- Developing, coaching, and managing key functional staff and inspiring and developing talent Collaborating with the global team and the sales leaders to ensure a coordinated approach. Leading cross-functionally with Legal, Medical, Clinical, Regulatory, Managed Markets, Public Affairs, Compliance and other functions Cultivating relationships with thought leaders, key customers, and professional organizations Working in close conjunction with marketing operations to establish appropriate procedures, systems, metrics and infrastructures Managing Marketing OpEx and marketing mix optimization Representing ISL-LEN marketing position on Promotional Review Committee and ISL-LEN Global Commercial Team Key Competencies: Results orientation: Thrive in a fast-paced, high-growth environment, with a strong drive to meet and exceed goals, even under adverse circumstances. Hold others accountable and incorporate disciplined processes to ensure success and nimbly handle 'derailments' with contingency plans and coordination. Vision: Adept at clearly defining objectives and priorities and establishing appropriate milestones through a strong understanding of the market and innovative approaches. Team leadership: Demonstrated ability to build, develop and motivate a team as evidenced by effective hiring, coaching, and mentoring of direct reports. The ideal candidate will develop an inclusive culture comfortable with challenging current market paradigms to achieve and exceed goals, respecting Gilead core values of integrity, accountability, teamwork, excellence, and inclusion. Strategic Orientation: Articulate evolving priorities for the business, identify market opportunities and adapt short-term plans. This includes the ability to strategically assess customer needs and build/execute specific, segmented strategies to win business across a diverse set of customers. Collaboration and Influence: Ability to work effectively with others and have an impact by demonstrating competence and confidence, being approachable and accessible, active listening, credibility and integrity, passion, and persistence as appropriate to the audience and issue at stake. Skilled at influencing outcomes and shaping and catalyzing dialogue across and outside the organization. Basic Qualifications: Bachelor's Degree and Sixteen Years' Experience OR Masters' Degree and Fourteen Years' Experience OR PhD and Fourteen Years' Experience Preferred Qualifications: 15+ years pharmaceutical industry experience including expertise in marketing strategy and tactics and commercial policies and practices Proven record of leading product launch and brand growth Knowledge and experience in rare disease or liver disease preferred Proven experience with pharmaceutical regulatory requirements (OPDP) and impact on development of marketing materials in accelerated approval Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines. Proven strategic capabilities with ability to conceive, develop and implement multidimensional marketing and business plans Demonstrated excellence in project management and effectively managing multiple projects/priorities Strong communication skills with experience presenting before executive staff Firm command of financial management with an understanding of revenue forecasting and expense budget planning and tracking. Experience managing cross-functional teams or work groups as well as direct reports Sales/market research experience is preferable, though not required MBA preferred, Bachelor's degree in marketing or related fields required 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.

SUMMARY/JOB PURPOSE: The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of oncology clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation. ESSENTIAL DUTIES AND RESPONSIBILITIES: · Review study documents to manage oncology clinical trials, determine operational risks, and develop mitigation plans to address risks proactively · Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL · Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. · Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues · Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) · Review compound-specific ICF and develop study-specific ICF templates · Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection · Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents · Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites · May coordinate the preparation, conduct, and presentations at Investigator Meetings · Review monitoring visit reports for completeness, accuracy, and adherence to the protocol · Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation · May conduct UAT for EDC / IRT and data listing review of EDC data for analysis · Compile and review appendices for preparation of clinical study reports · Review and/or create study documents (e.g. newsletters, and various study / site trackers) · Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion · Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately · May assist in materials preparation for strategic governance discussions as required SUPERVISORY RESPONSIBILITIES: · None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: · BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or, · MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or, · Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: · Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research Knowledge/Skills: · Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation · Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures · Experience with development of prospective site-selection criteria · Familiar with medical terminology, and basic concepts of clinical research · Ability to deal with time demands, incomplete information or unexpected events · Experience in interactions with outside vendors, e.g., CROs and contract labs · Demonstrated ability to write and present clearly using on scientific and clinical issues terminology · Applies technical standards, principles, theories, concepts and techniques · Advanced computer skills · Good organizational and planning skills · Strong interpersonal skills and communication skills (both written and oral) · Ability to work effectively in a team/matrix environment · Ability to understand technical, scientific and medical information · Demonstrated success in problem-solving · Self-motivation, eagerness to grow professionally and commitment to self-development JOB COMPLEXITY: · Works on assigned problems of moderate scope with analysis of situation or data required. · Exercises judgment within defined procedures and practices to determine appropriate action. · Builds productive internal and external working relationships. · Uses professional concepts and company policies and procedures to solve a variety of routine problems. · Demonstrated professional collaboration skills · Capable of identifying task-related challenges and prioritizing activity accordingly DESIRED BEHAVIORS: · Resilient in the context of a rapidly changing environment · Organized with a systematic approach to prioritization · Works independently to meet objectives and completes tasks within established timelines. · Expresses curiosity, asks questions and shares perspective, appropriately EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: · We drive for results, so patients can survive and thrive. · We are resilient in the face of adversity, and tireless in advancing our science. · We celebrate our long history of prolific drug discovery and rigorous drug development. · We unite to launch innovative medicines for difficult-to-treat cancers. · We exist to give people hope - one drug, one patient at a time. · We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: · Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way), · Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results) · Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: · Travel may be required up to 20% in support of clinical study activities #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $108,500 - $153,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Adverum is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the capabilities of its proprietary intravitreal platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians' offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. Additionally, by overcoming the challenges associated with current treatment paradigms for debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe. Note to Recruiters and Agencies All recruiter and agency inquiries must go through Adverum's internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered property of Adverum. Agencies must be expressly engaged by Adverum's Talent Acquisition team for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future. At Adverum, we're always excited to meet people who share our mission. If you don't see a role that fits today, share your details-we're always looking to connect with those who believe that great science starts with great people. At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space that allows for everyone in our Adverum Community to not only feel safe but also encouraged to speak, learn from each other, grow in their professions, and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.

SUMMARY/JOB PURPOSE (Basic purpose of the job): The Director of Statistical Programming Standards & Infrastructure provides strategic leadership and oversight for the development, implementation, and maintenance of global statistical programming standards, tools, and infrastructure. This role ensures compliance with regulatory requirements, industry standards (e.g., CDISC), and internal quality processes. The Director will partner with cross-functional teams, including Biostatistics, Clinical Data Management, and IT, to drive innovation, efficiency, and consistency in statistical programming deliverables across studies and submissions. ESSENTIAL DUTIES/RESPONSIBILITIES: Define and execute the vision for statistical programming standards and infrastructure aligned with organizational goals. Establish governance for global programming standards, tools, and processes. Oversee creation, validation, and lifecycle management of global macros, standard programs, and reusable code libraries. Ensure adherence to SDLC principles for all programming tools and infrastructure components. Drive initiatives to enhance automation, scalability, and efficiency in programming workflows. Collaborate with IT to maintain robust, secure, and compliant programming environments. Ensure deliverables meet CDISC standards (SDTM, ADaM) and regulatory requirements (e.g., FDA, EMA). Oversee quality control processes for CRO deliverables and internal outputs, including datasets and TLFs. Partner with Biostatistics, Clinical Data Management, and other stakeholders to align standards and infrastructure with clinical development needs. Serve as subject matter expert for programming standards during audits and regulatory inspections. Lead and mentor a team of statistical programmers and standards specialists. Manage resource allocation, training and career development for team members. Identify emerging technologies and best practices to advance programming capabilities. Champion process improvements and standardization initiatives across the organization. SUPERVISORY RESPONSIBILITIES: Directly manage a team of statistical programming standards and/or infrastructure. Provide leadership, coaching and performance management to ensure team success. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: BS/BA degree in a related discipline and a minimum of 13 years of relevant experience; or, MS/MA degree in a related discipline and a minimum of 11 years of relevant experience; or, PhD in a related discipline and a minimum of 8 years of relevant experience; or, Equivalent combination of education and experience. Experience: Extensive experience in pharmaceutical/biotech statistical programming, including NDA/BLA submissions. Proven track record in developing and implementing programming standards and infrastructure. Strong proficiency in SAS/Base, SAS/Stat, SAS/Macro; programming experience in R and Python is a plus; experience with CDISC standards and SDLC. Familiarity with oncology clinical trials preferred. Knowledge, Skills and Abilities: Strategic thinking with ability to translate vision into actionable plans. Strong leadership and team management skills. Good managerial and organizational skills. Excellent communication and collaboration abilities. Knowledge of appropriate FDA regulations, industry standards and guidance documents. Understands clinical research process, trial designs, and the development of protocols and analysis plans. Experience authoring SOPs and work instructions. Works on highly complex problems requiring strategic analysis and innovative solutions. Influences organizational policies and practices related to statistical programming standards and infrastructure. Networks extensively with internal and external stakeholders to drive alignment and adoption of standards. Work Environment/Physical Demands: Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. #LI-JP1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $198,000 - $281,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.