Sutro Biopharma jobs in South San Francisco, CA - 701 jobs

Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Clinical Operations team as we change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing our technology and progressing our novel therapeutics. We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team. The Clinical Trial Associate (CTA) will provide support for the Clinical Operations team with the day-to-day activities of executing for one or more clinical trials during the trial start-up, conduct, and close-out periods, in accordance with the appropriate clinical trial standards including ICH/GCP and applicable regulations. This position is located at Sutro's headquarters in South San Francisco, California. Responsibilities: Support the execution of clinical study from start to close-out Support the Clinical Trial Manager on assigned tasks working closely on assigned study management activities Maintain clinical study documents, ensuring compliance with Good Documentation Practices Coordinate clinical operation team with meetings, prepare agenda, and meeting minutes Manage the acquisition and distribution of clinical trial material Maintain study files which includes filing documents in eTMF Track study expenses and invoices as directed by CTM Maintain study trackers and provide updates (data entry, enrollment etc) As a CTA you will work closely with the Clinical Operations team to support the full scope of study activities, including site activation, patient recruitment, study monitoring and site and vendor management on Phase 1 to Phase 3 trials You will work cross functionally within the Sutro team as well as with study sites, CROs and other vendors Responsible for site feasibility and recruitment, including review of Site Information Questionnaires Review assigned clinical documents (i.e. protocols, ICFs, and manuals) for clarity and accuracy and following ICH/GCP guidelines Reviews study plans, including; Clinical Monitoring, Communication, Project Management and electronic Trial Master File (eTMF) Management Review of data fields within the electronic data capture (EDC) systems, including performing and collating and downloading reports to support study management and data review Participates in assigned activities related to user acceptance testing (UAT) of clinical systems, including EDC and interactive response technology (IRT) and may contribute to the authoring of systems requirements Reviews and tracks required essential regulatory documentation from clinical sites prior to study start-up as well as updates during study conduct Conducts site specific Informed Consent Form (ICF) review Reviews Site Visit Reports for accuracy, quality and consistency Assist with activities related to management of study vendors Assist in performance of TMF QC and reconciliation of findings Responsible for clinical team meeting scheduling, agendas and minutes Oversight of CRO and vendor minute review and finalization Maintains trackers and updates routine study dashboards Represents department in a professional manner; build and establish good relationships with investigators and all other study personnel Builds effective working relationships internally Qualifications: University/college degree in health care or other scientifically related discipline is required. Bachelor's degree is preferred 1-2 plus years of industry experience with 1 or more years of experience in= clinical operations, study coordinator, data management, site monitoring and/or nursing experience preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility Understanding of ICH/GCP and knowledge of regulatory requirements (eg. ICH/CFR guidelines) Experience of working as part of a large team, clear written and verbal communication skills and ability to partner with various stakeholders are critical for success in this role Proven ability to proactively identify and resolve/refer project-related operational issues; ability to work independently on routine assignments, or under supervision on new assignments. Ability to handle a moderate volume of highly complex tasks within a given timeline. Requires strong organizational skills, attention to detail and ability to prioritize and problem solve. Willingness to travel as necessary, consistent with project needs Computer proficiency (Outlook, MS Word, Excel, and PowerPoint) Some travel (domestic and international), up to 15% Sound exciting? Apply today and join our team! Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment. As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together. We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies. The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma's California based locations will be $85,000 - $115,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education. About Sutro Biopharma Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients. Dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro's platform has led to ADCs, bispecific antibodies, cytokine-based immuno-oncology therapies, and vaccines directed at precedented targets in clinical indications where the current standard of care is suboptimal. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit ***************** |

A leading biopharmaceutical company in Foster City is seeking an Associate Director/Principal Scientist to lead cell culture development for biologics programs. The ideal candidate will have significant experience in process development and team management, with a Ph.D. or relevant degree. This role involves optimizing processes, mentoring team members, and ensuring compliance with regulatory requirements. #J-18808-Ljbffr

United States - California - Foster City Process/Product Development & Operations Regular The Associate Director/ Principal Scientist , Cell Culture Process Development (Pivotal & Commercial), will be responsible for leading aspects of cell culture development including commercial process development and process characterization for multiple biologics programs during pivotal phases (phases II/III and post-launch). In addition, this role is also expected to lead projects for cell culture process technology development, platform process evolution, and to support cell culture-related regulatory documentation. Key Responsibilities Optimize and characterize cell culture processes to supply pivotal trials and enable commercialization for monoclonal antibodies, multi‑specifics, and novel modalities. Lead and/or support entire lifecycle of pivotal activities including process risk assessment, process characterization, preparation of all supporting documentation/reports toward BLA submission, provide support to ensure successful process performance qualifications (PPQ), and author relevant sections of BLA. Lead and/or support technology transfer and investigation activities in partnership with the global manufacturing sciences and technologies (MSAT) group. Design experiments and perform hands‑on cell culture operations in shake flasks, ambr15, ambr250, bench‑scale bioreactors, and novel cell culture platforms. May provide support to pilot plant operation for up to 500 L single‑use bioreactor. Perform statistical analyses and appropriate modeling to assess process parameter criticality, identify acceptable ranges, and contribute to integrated control strategy. Author and review GMP and non‑GMP technical documents (reports, regulatory submissions/responses, batch records, SOPs etc.), present in group/cross‑functional meetings. Participate and work cross‑functionally within and outside of biologics technical development to achieve common goals. Explore, develop, and implement novel cell culture technologies to meet business needs. Manage direct and indirect reports and mentor junior group members while working in a flexible and agile environment. Some travel may be required to support technology transfers and provide oversight at external manufacturing facilities. Adhere to department budget and all training, compliance and safety requirements. Remain current on trends and new technology advancements across the Biopharmaceutical industry. Hire, mentor and develop team members within the organization to help build and grow a world‑class biologics cell‑culture process development organization. Qualifications Ph.D. with 5+ years OR M.S. with 8+ years OR B.S. with 10+ in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering). Experience leading pivotal stage cell culture process development/characterization and implementation in GMP facilities. Experience in building high‑performing teams through strategic coaching and feedback. Hands‑on laboratory operations experience including shake flask, high‑throughput bioreactor, bench scale bioreactor, and pilot scale cultures. Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving. Demonstrated ability to collaborate and influence cross‑functionally. Experience in cell culture media development, and/or employing modeling techniques for upstream process development and optimization is preferred. Experience in statistics, design‑of‑experiments, and data analysis (e.g. JMP, Spotfire). Working knowledge of lab automation, data management, data science, knowledge management and data protection. Experience with viral vaccines is a plus. Passion for inclusion: knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way he/she/they work. #J-18808-Ljbffr

Executive Director, Clinical Data Acquisition page is loaded## Executive Director, Clinical Data Acquisitionlocations: Alameda, CAtime type: Full timeposted on: Posted 30+ Days Agojob requisition id: JR6341**SUMMARY/JOB PURPOSE** **(Basic purpose of the job):**The Executive Director, Clinical Data Acquisition (CDA) is accountable for managing a team focused on the strategic and operational leadership of quality data collection activities across all clinical studies Phase I to IV. This includes, but is not limited to, the development and maintenance of policies, procedures, and data standards, maximizing usage of Electronic Data Capture (EDC) systems to ensure timely and high quality data collection, and proactive management of external vendors delivering clinical data using controlled, compliant, and secure methods. The Executive Director, CDA is accountable for the hiring, training, development, and management of employees within the departmental scope, to meet current and future business needs.This incumbent must be capable of representing Clinical Data Management (CDM) and Data Science & Biometrics (DSB) in a leadership capacity. The role requires strong partnership and close collaboration with senior functional and matrix leaders across the R&D organization to ensure the successful, efficient, high quality, and compliant work delivery supporting the company portfolio.**ESSENTIAL DUTIES/RESPONSIBILITIES:*** Responsible for defining, and driving, the vision for optimized data collection that capitalizes on the latest technologies, is compliant with global regulatory requirements & guidances, and results in timely high quality clinical data generation.* Ensure end-to-end management of all CDA activities including, but not limited to, company data standards, eCRF development, external data transfers/integration and reconciliation, and appropriately ensuring validation of clinical data systems and data repositories.* Provide day-to-day leadership of the CDA team (employees, contractors, functional service providers) to instill a work ethic focused on proactive engagement and thought partnership with other roles in CDM and DSB, Information Technology, Strategic Sourcing & Procurement, Development Operations, Clinical Development, Global Patient Safety, and beyond.* Maintain oversight of record retention strategies for clinical data and associated documentation in accordance with all applicable global regulations, company policies & procedures, and study-specific needs. This includes, but is not limited to, archival of clinical data at investigational sites, decommissioning of EDC systems, and contemporaneous storage of documentation in study-specific and/or system-specific document repositories (e.g. eTMF).* At the study and portfolio level, proactively drive quality, efficiency, and innovation to ensure data collection deliverables are met within the established timelines, budget, and quality/compliance standards (e.g. providing input to protocol design, database design, and validation, and data management plans, including data review strategies and data quality assurance).* Establish, and/or provide leadership in, governance structures working with relevant vendors including, but not limited to, data management vendor(s), sample management vendor(s), to ensure effective quality oversight of vendor deliverables and relationships supporting the company portfolio.* Lead data standardization initiatives to ensure data collection methods comply with regulatory requirements, industry standards (e.g. CDISC), company policies & procedures, portfolio-level standards, and the practical needs of individual studies.* Develop and implement a continuous process improvement strategy by monitoring key performance indicators, metrics, quality, and timeliness of study deliverables across the portfolio.* Drives cross-functional senior leadership engagement to develop and deliver solutions for new service capabilities.* Contribute to the development of departmental and study budgets, proactively managing budget, including accurate forecasting and cost accruals.* Proactively identify and troubleshoot operational problems, issues, and obstacles, that help study teams to remove barriers to execution.* Support study teams during submission, inspection, and other regulatory-related activities including, but not limited to, developing oversight processes, creating storyboards, presenting issues and mitigations.* Strong customer focus and belief in Exelixis values; creating a positive value-based work environment for the CDA team. Able to lead, inspire and influence team/organization through rapidly changing business challenges.* Stay current with regulatory and industry advances through cultivation of a wide external network. Able to represent Exelixis in data management, data strategy and other related capacities. Helps establish and maintain Exelixis CDM as an industry leader.* May perform day-to-day tactical responsibilities to ensure successful execution of clinical studies across the company portfolio.**SUPERVISORY RESPONSIBILITIES:*** Directly and indirectly supervises employees.* Responsible for the growth and development of all CDA employees.* May indirectly supervise employee(s) through a dotted line structure.**EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:****Education:*** BS/BA degree in related discipline and a minimum of 18 years of related experience; or,* MS/MA degree in related discipline and a minimum of 16 years of related experience; or,* PhD in related discipline and a minimum of 15 years of related experience; or,* Equivalent combination of education and experience.* May require certification in assigned area.**Experience:*** Typically requires a minimum of 18 years of related experience and/or a combination of experience and education/training.* Experience in Biotech/Pharmaceutical industry required.* Experience in Oncology clinical trials is preferred.* Experience leading major change initiatives is preferred.* Demonstrated experience leading global data management and/or technical teams is required.* Experience participating in regulatory submissions and inspections is required.* A minimum of 12 years of line management experience is required.**Knowledge, Skills and Abilities:*** Has extensive experience in relevant industry/profession.* Excellent understanding of clinical development, quality and regulatory standards (e.g.CDISC) and policies relevant to data management (e.g. GCP, ICH).* Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.* Develops technical and/or business solutions to complex problems.* Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.* Guides the successful completion of major programs, projects and/or functions.* Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.* Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.* Has complete understanding and wide application of technical principles, theories, concepts and techniques.* Has extensive knowledge of other related disciplines.* Applies strong analytical and business communication skills.* Ability to identify, author, maintain and train staff on key data management SOPs and work-practice guidelines.* Knowledge of Good Clinical Practices (GCP) is essential.* Demonstrated success managing data management activities performed by external vendors.* Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.* #J-18808-Ljbffr

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a Director, Quality Site Lead located in Foster City, CA. Job Functions Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned Strategic 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 member of Business Review Meetings with CXO as Quality's voice for the contract organizations' oversight. Maybe member or backup member of Joint Steering Committee. 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. Accountable for multiple external QA functions, including quality events, validation, and release/disposition. Partner with internal stakeholders such as Global External Manufacturing, Global Supply Chain, Pharmaceutical Development, and Reg 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. Travel to CXO site(s) to provide Quality oversight of critical manufacturing activities, as required. 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. 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. May back up Pillar Lead, as needed. Champion Quality Risk Management, identifying key risks impacting CXO performance. Ensure PAI/PLI Readiness for assigned CXO sites. Up to 20% travel based on strategic plan. Manages 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. Expert in prioritizing workload to address competing projects and timelines. Basic Qualifications 12+ years of relevant experience and a bachelor's degree in science or related fields; or 10+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA. Prior experience leading, developing and managing people. Knowledge in technical and regulatory requirements pertaining to manufacturing, testing, 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. Significant experience with different pharmaceutical modalities, e.g., active pharmaceutical ingredients, parenteral, biologics, and medical device preferred. Broad experience across several areas like CMO QA, Validation, Drug development experience, packaging/labeling and understanding of Parenteral, OSD, and Biologics. 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. Job Requisition ID R0048129 Job Level Director #J-18808-Ljbffr

A leading biotech company located in California is seeking a Director of Cloud Engineering. This role involves leading cloud product management initiatives, overseeing AWS infrastructure, and driving product strategies that align with the company's mission to innovate medicines. The ideal candidate will possess significant experience in IT leadership, ideally within a biopharma context, and have a proven track record in AWS and product management methodologies. Competitive compensation and a collaborative work environment are offered. #J-18808-Ljbffr

A leading biotech company is seeking a Senior Staff Engineer - Client Technology positioned in Alameda, California. This senior role involves overseeing IT platforms, driving product strategy, and delivering scalable solutions. Candidates should have extensive experience in technical leadership, strong scripting skills, and the ability to coordinate cross-functional initiatives. A competitive compensation package includes a salary range of $149,000 - $212,000 and comprehensive employee benefits. #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 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. 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. #J-18808-Ljbffr

United States - California - Foster City Public Affairs/Communications Regular We are seeking a dynamic mission driven Director of Public Affairs to join our team and become a leader on our advocacy community relations and sponsorship initiatives. This individual will serve as a key external face of the company, building and nurturing relationships that support our business objectives and deepen our connections with the communities we serve. The ideal candidate brings energy, creativity and passion for making an impact. We're looking for someone who is proactive, thrives in a fast paced environment and is empowered to take initiative. Key Responsibilities Develop and execute public affairs strategies that align with company priorities Build relationships with policymakers, advocacy organizations, and stakeholders to advance healthcare related initiatives Serve as the company's representative in community partnerships, coalitions and public forums Identify and cultivate relationships with local leaders FQHCs, advocacy groups and nonprofit organizations Responsible for public relations programming within the Public Affairs group, in particular supporting the company's growing portfolio of products and pipeline programs Effectively manage all aspects of public relations agency relationships, such as providing direction and project management Manage budgets to target Collaborate and regularly participate as a member of cross-functional teams, representing external communications function; provide public relations recommendations to help achieve company goals Develop and implement media relations strategies for specific areas of responsibility, such as product and/or corporate related initiatives Serve as media spokesperson for product and/or corporate news; respond to media requests and arrange interviews with management and opinion leader spokespeople as appropriate Examine complex issues from a broader organization perspective, determine communications opportunities and help determine priorities within the Public Affairs group Prepare press releases, presentations and other communications materials with minimal oversight Qualifications Bachelor's Degree and 12 Years' Experience Masters' Degree and 10 Years' Experience PhD and 8 Years' Experience Preferred qualifications Demonstrated experience in media relations; knowledge of industry media and reporting trends Demonstrated knowledge of regulations and principles specific to communications for a publicly‑traded biopharmaceutical company Must have experience with public relations tactics and resources and the relationship of those tactics to other department roles and functions, including marketing, medical affairs, government affairs and investor relations Experience managing multiple projects (timelines, budgets, priorities) simultaneously Excellent verbal, written and interpersonal communication skills People Leader Accountabilities Create Inclusion - knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. #J-18808-Ljbffr

A leading biopharmaceutical company in California seeks a Director, Global Trade Compliance to oversee its trade compliance and logistics. The role involves leading compliance efforts, managing customs and global logistics, developing policies, and conducting training. Candidates should hold a relevant degree with extensive experience in trade compliance, and possess strong communication and leadership skills. Competitive compensation and comprehensive benefits are offered. #J-18808-Ljbffr

Director, Comparator Sourcing, Global Clinical Supply Chain (GCSC) Director, Comparator Sourcing, Global Clinical Supply Chain (GCSC) United States - New Jersey - Parsippany, United States - California - Foster City Manufacturing Operations & Supply Chain Regular The Director, Comparator Sourcing, Global Clinical Supply Chain ( GCSC) is responsible for providing leadership over the comparator sourcing strategy and timely delivery management. This Director, Comparator Sourcing, GCSC will effectively manage relationships with vendors and Procurement as needed and acts as the point escalation for the planning organization on issues for comparator provision. As a key contributing member of the GCSC Leadership Team (GCSC LT), you will ensure strategic alignment to Gilead's development portfolio and strategic goals as well as build strong relationships with Gilead functional leadership (including and not limited to Clinical Supply Planning and Management (CSPM), Clinical Operation, Regulatory, Quality and the rest of PDM) to ensure alignment of the organizations and prompt resolution of critical issues. You are considered an expert, with working knowledge of supply chain best practices and experience working with a GxP environment. The Director, Comparator Sourcing, GCSC has a strong cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company. Focus Areas: Oversees the collaboration with CSPM and other cross-functional teams to understand the comparator requirements for clinical studies. Develops efficient, effective and compliant sourcing strategies to deliver the comparators on time in full. The sourcing strategies are measured based on maximizing supply efficiency, minimizing waste while identifying risks and developing as well as communicating risk mitigation plans. Partners with Procurement, Quality and Regulatory for the identification, qualification and management of comparator sourcing vendors in support of Gilead's portfolio. Builds an infrastructure for the collection of comparator information, ensuring resident expertise is established for types of comparators on the market, including pack sizing. Ensures on time responses between the vendors, Procurement and CSPM in support of delivery for the required comparators on time. Ensures support is provided to CSPM and other key stakeholders in providing supporting documentations for the comparators - e.g. SmPC, product specs, etc. Ensures tracking of target of delivery to CMOs support release activities. Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure - e.g. time of environment (TOE), temperature excursions, etc. Responsible for informing and/or escalating market recalls, withdrawals and safety alerts as related to sourced comparators. Builds strategic relationships with internal functional groups and ensures alignment. Participates or leads process improvement initiatives cross functionally with stakeholders contributing to global/regional initiatives or programs. Participates in CD&OP reviews, presents comparator supply delivery performance and facilitates related discussions as required. Ensures robust systems and processes are in place to enable execution of operational and logistical tasks in a GxP compliant manner. Collaborates and authors department policies and procedures. Basic Qualifications: Advanced scientific degree (i.e., PhD) and 8+ years of supply chain experience in the biotech/pharmaceutical industry OR Master's Degree and 10+ years of supply chain experience in the biotech/pharmaceutical industry OR Bachelor's Degree and 12+ years of supply chain experience in the biotech/pharmaceutical industry Preferred Qualifications: Bachelor's degree in Supply Chain, Business, Science, or Engineering discipline. Master's degree and/or professional qualifications in Supply Chain Management desired. 12+ years progressive experience in supply chain, preferably within biotech, pharmaceutical, CRO industry with 5+ years in comparator sourcing. Experience working in a global, complex supply chain organization within the biopharma industry. Experience building and leading teams from multi-disciplinary departments. Strong ability to collaborate and build strategic relationships with internal stakeholders - Clinical Operations, Quality, Regulatory, CMC, etc. Demonstrates advanced knowledge of global clinical trials and the drug development process. Experience in vendor oversight and managing external partnerships and relations. Experience with comparator sourcing. Understanding of IRT system functionality and forecast modeling. Awareness of comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, ICH/GDP, GCP, 21 CFR Part 11 and EU CTR Annex VI, etc.). Experience in deviation investigation and CAPA implementation. Ability to work effectively in cross-functional and multi-cultural teams. Gilead Core Values Integrity (Doing What's Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) Share: Job Requisition ID R0045026 Full Time/Part Time Full-Time Job Level Director Click below to return to the Gilead Careers site Click below to see a list of upcoming events Click below to return to the Kite, a Gilead company Careers site #J-18808-Ljbffr

A leading biotechnology firm in Alameda seeks a Director of Statistical Programming Standards & Infrastructure to lead development of programming standards and tools across studies. The role demands extensive experience in statistical programming, collaboration with various teams, and solid understanding of regulatory compliance. Candidates should possess a BS/BA and have a proven track record in enhancing efficiency in programming workflows. Competitive compensation package offered, including bonuses and comprehensive benefits. #J-18808-Ljbffr

A leading biopharma company is looking for a Senior Business Development Search & Evaluation Director in Alameda, CA. This role involves sourcing and evaluating partnerships in oncology, building relationships in biopharma and academia, and leading due diligence. Ideal candidates will have extensive experience in oncology, relationship management, and negotiation skills, along with a strong educational background in life sciences. The position offers a competitive salary and comprehensive benefits. #J-18808-Ljbffr

A leading biotech company is seeking a Senior Director of IT Product Management to oversee a portfolio of digital products. This role demands strategic thinking, strong leadership, and expertise in enterprise applications within the life science sector. Responsibilities include driving product strategy, ensuring compliance with regulatory standards, and enhancing user experience. The ideal candidate will have extensive experience in IT leadership and product management. #J-18808-Ljbffr

Sutro Biopharma is seeking a hands-on, experienced IT professional to join our team as an IT Infrastructure Services Specialist. This role focuses on the reliability, security, and performance of enterprise and laboratory computing environments, with a strong emphasis on Windows and mac OS endpoints. The position serves as a senior escalation resource for desktop and computer lab support while contributing to the systems and services that underpin end-user computing. The ideal candidate enjoys working close to the hardware and operating system layer, improving workstation stability, and partnering with scientists and business users to keep critical computing environments running smoothly.Responsibilities Advanced Endpoint Support & Escalation Independently resolve moderate to advanced endpoint issues, including OS-level troubleshooting, application conflicts, hardware failures, driver issues, and peripheral integration. Act as the primary point of contact for complex desktop and lab computer incidents, escalating to IT support staff with troubleshooting strategies and root-cause analysis. Develop, refine, and document standardized workstation builds, deployment, and support procedures for Windows and mac OS systems. Support installation, configuration, and maintenance of specialized research, analytics, and productivity software across PC and Mac platforms. Endpoint & Core Systems Management Administer and support core services that enable endpoint computing, including File Services, Active Directory, Entra ID, Power Automate, Office365, Microsoft Exchange Online and Google Cloud Platform. Manage patching, OS updates, endpoint security, and configuration standards for enterprise and lab workstations. Operate and maintain endpoint management and protection platforms such as Workspace One, Microsoft Intune, Barracuda Backups, OneDrive, and Varonis. Monitor endpoint health and security posture using tools such as Microsoft Defender and Darktrace, responding to issues and improving baseline configurations. Projects & Cross-Functional Collaboration Lead endpoint-focused initiatives such as workstation refresh programs, lab computer deployments, OS migrations, and application rollouts. Partner with Research, Tech Ops, Finance, and the IT team to deliver practical, supportable computing solutions. Coordinate with management and external vendors on projects that impact end-user and lab computing environments. Controls, Documentation & Best Practices Support SOX-related controls by implementing consistent endpoint standards, improving documentation, and assisting with audits and remediation activities. Create and maintain technical documentation, SOPs, and system inventories related to endpoint and user-facing infrastructure. Assist with the ongoing improvement of identity and access management practices, including SSO and MFA, as they relate to workstation and application access. Qualifications:Experience & Education 5-8 years of progressive IT experience with a strong emphasis on endpoint support, desktop engineering, or end-user computing in a professional environment. Life Sciences experience preferred. Bachelor's degree in Computer Science or equivalent hands-on experience. Relevant certifications (Microsoft, Azure, Google Cloud Platform, endpoint management, or security-focused) are a plus but not required. Technical Skills Strong troubleshooting skills across Windows and mac OS operating systems in mixed environments. Hands-on experience managing and supporting endpoints using tools such as Workspace One, Microsoft Intune, and Group Policies. Practical working knowledge of Active Directory, Entra ID, and hybrid identity environments. Comfortable supporting both PC (~75%) and Mac (~25%) systems, including hardware, peripherals, and OS-level issues. Solid understanding of networking fundamentals (TCP/IP, VLAN, VPN) as they relate to endpoint connectivity and remote access. Professional Attributes Hands-on, service-oriented technologist who enjoys solving real-world computing problems. Strong communication skills and the ability to translate technical issues for non-technical users. Organized, detail-oriented, and comfortable operating in a fast-paced, on-site and remote environment. Familiarity with wearing PPE in lab spaces and able to lift computer equipment weighing up to 40 lbs. Sound exciting? Apply today and join our team! Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment. As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together. We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies. The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma's California based locations will be $103,000 - $133,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education. About Sutro Biopharma Sutro Biopharma, Inc. is advancing a next-generation antibody-drug conjugate (ADC) platform designed to deliver single- and dual-payload ADCs that enable meaningful breakthroughs for patients with cancer. By fully optimizing the antibody, linker, and payload, Sutro's cell-free platform produces ADCs that are engineered to improve drug exposure, reduce side effects, and expand the range of treatable tumor types. With unique capabilities in dual-payload ADCs, Sutro aims to overcome treatment resistance and redefine what's possible in cancer therapy. The Company's pipeline of single- and dual-payload ADCs targets large oncology markets with limited treatment options and significant need for improved therapies.

* Depth of experience in the pharmaceutical/biotechnology industry, having held leadership roles in the US and outside the US.* Previous full P&L responsibility and financial success as a GM (or GM-equivalent) across large market(s) and cluster(s)/region(s).* Expertise in global product strategic planning, tactical marketing, commercial policies and practices, new product planning, portfolio management and lifecycle management* Proven general management, with enterprise mindset and strong people leadership: ability to lead change, inspire followership, motivate, and develop a team, possessing excellent interpersonal skills to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines.* Global mindset and experience, including experience in emerging markets and passion for resource-limited countries. Globally aligned and locally relevant decision-making. Ability to navigate the matrix and influence/negotiate from a lower priority position.* Track record of successfully working with the relevant government/public agency and health authorities* A ‘leader of leaders' with previous experience leading a global team, preferably in complex and matrixed environments. Demonstrated ability to structure and oversee large-scale, complex partnerships. Lead & drive competitive fitness and overall accountability within geographically and culturally diverse cross-functional workforce.* Direct experience in strategic planning and strategic marketing in HIV, Hepatitis, CV, and/or Oncology products is preferred* Travel Requirement: 30-40%* The preferred location for this position is Foster City, CA; Stockley Park, UK is a secondary however less-preferred option.* >18 years' experience in the pharmaceutical/biotechnology industry* Minimum of 7 years' experience with full responsibility for P&L and proven financial success as a GM (or GM-equivalent) across large, global market and/or cluster.* Bachelors/Advanced degree 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. #J-18808-Ljbffr

**SUMMARY/JOB PURPOSE (Basic purpose of the job):**The Senior Director IT Product Management, SAP Platform, will oversee and lead a portfolio of digital products critical to Exelixis's success and ambition to launch innovative medicines for patients. This role is pivotal in defining and driving the strategy, development, and operational excellence of our Enterprise Resource Planning ecosystem, ensuring alignment with business objectives and a strong focus on user experience and value delivery. Operating within a product-centric model, the Senior Director will be responsible for defining product roadmaps, fostering cross-functional collaboration, and leading agile product teams to deliver innovative and impactful digital solutions that accelerate drug discovery, development, and commercialization.**ESSENTIAL DUTIES/RESPONSIBILITIES:**Champion a user-centric design approach, leveraging user research, usability testing, and feedback loops to continuously improve the user experience and effectiveness of enterprise solutions across multiple enterprise products and business functions.Define and enforce all enterprise applications, feature releases and processes comply with relevant regulatory requirements (e.g., GxP, HIPAA, GDPR, SOX) and internal quality and security standards.Ensure that all product releases meet rigorous quality standards and compliance requirements. Partner with quality and compliance leaders to re-define and update standards as needed.**SUPERVISORY RESPONSIBILITIES:** **EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:** **Education:** Bachelor's degree in related discipline and 15 years of related experience; or Master's degree in mathematics or statistics or engineering and 13 years of related experience.PhD degree in a related discipline and 12 years of related experience; or Equivalent combination of education and experience. **Experience/The Ideal Candidate will have:** Minimum of 10 years of experience supporting Enterprise IT enabling business functions.Minimum of 12+ years of progressive experience in IT, with at least 8+ years in a leadership role focused on enterprise applications or product management within the life science or pharmaceutical industry.Proven experience in leading product development teams in an agile/product-centric operating model is essential. Experience managing and implementing supply and demand planning solutions (e.g. Kinaxis) Experience with integration platforms, such as CPI (Cloud Platform Integration), Integration Suite or other similar middleware Experience with regulatory frameworks and compliance in a SOX and GxP environment including IT General Controls (ITGC) and Segregation of Duties (SoD).**Knowledge / Skills:** Exceptional leadership and team-building skills, with the ability to inspire and motivate diverse teams. Strong strategic thinking and problem-solving abilities, with a data-driven approach to decision-making. Excellent communication, presentation, and interpersonal skills, with the ability to influence and collaborate effectively at all levels of the organization. Solid technical acumen with the ability to understand complex IT architectures and development processes. Ability to manage multiple priorities in a fast-paced, dynamic environment. 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

A leading biotech company in Alameda, California, is seeking an Assoc Scientific Regulatory Writing Director to lead the development of regulatory documents. This role requires extensive experience in the biotech/pharmaceutical industry and a strong understanding of regulatory submissions. The ideal candidate will possess excellent communication and project management skills, ensuring high-quality content is delivered on time. This position offers a competitive salary and comprehensive benefits package. #J-18808-Ljbffr

**Job Description****General Summary:**The Pain Territory Business Manager (TBM) is responsible for establishing and maintaining relationships with Health Care Professionals (HCPs) to promote the safe and effective use of JOURNAVX, a novel selective inhibitor of NaV1.8 in acute pain. The TBM reports into a Regional Field Leader and serves as a field representative for JOURNAVX within the community setting. The TBM will work closely with Pain Territory Account Managers (PTAMs) who are also field-based reps within the geographic area who serve as account managers within hospitals/health systems and are responsible for driving and pulling through hospitals/health system volume and access as well as targeted physicians within their hospital networks.**Key Responsibilities:*** Establishes meaningful and professional relationships with assigned physicians with the goal of building awareness and driving adoption of JOURNAVX.* Develops and maintains expertise on the product's clinical attributes and patient unmet need and educates healthcare professionals on product use in appropriate patients.* Develops a deep understanding of assigned physicians, territory & market dynamics, stakeholder mapping, key decision maker relationship management, patient protocols, referral network navigation, access, and drivers & barriers.* Implements and maintains strategic territory business plans that identify and harness business opportunities and patient-focused solutions for significant growth across the customer landscape while supporting the PTAM led account engagement strategy within hospital settings.* Drives sales performance and ensures forecasts and assigned budgets meet or exceed territory expectations.* Collaborates compliantly with other field team members (e.g., PTAMs, field medical, HEOR, IDN and Payer Account teams) and headquarter colleagues to create aligned business plans, focus on strategic drivers, share best practices, and inform initiatives.* Role models ethics and integrity in the work that you do to support our culture of compliance and earn trust with external stakeholders, particularly in the context of this market and its history.**Required Experience and Knowledge/Skills:*** 5+ experience in biotech sales; product launch experience is highly desired* Product launch experience in acute pain and successfully engaging with diverse physicians is highly desired.* Experience effectively engaging with retail pharmacies to ensure stocking and managed care pull through.* Experience with pulling through the implementation of inpatient formularies, protocols, pathways, and order sets.* Ability to understand the nuances of patient treatment in the geography, including but not limited to care coordination, patient referral patterns, and influence networks.* Highly competent in a multitude of IT capabilities to support the business needs including Veeva CRM.* Experience working in a highly matrixed environment.* Bachelor's degree**Other Requirements*** Employee will be required to establish certain customer credentials and requirements, which include, but may not be limited to, successful completion of trainings, background screens, drug testing and vaccinations.* Must live and work within the territory. Depending on the territory's geography and work requirements may also be required to live within a reasonable distance to a major airport.* Valid driver's license and in good standing.* Travel by car or airplane up to 80% of the time and work after hours as required by business needs.* 10-30% of overnight travel may be required depending on territory.**Pay Range:**$140,000 - $160,000**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an incentive bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordancewith federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Company Information**Vertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com. #J-18808-Ljbffr