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  • Clinical Trials Sales Director, BioPharma

    Alivecor 4.2company rating

    Remote Alivecor job

    Why join AliveCor At AliveCor, we imagine a healthier world powered by access to personalized intelligent information. We're on a mission to be the world's heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, millions of users have taken more than 200 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful - and AliveCor delivers: every day, customers tell us that we've saved lives. Join us in our mission! The Opportunity This is your chance to join AliveCor's expanding BioPharma team that partners with Clinical Research Organizations (CROs) and pharmaceutical companies to use our devices and services to advance drug development. Our solutions are used to enable clinical research, to screen patients for cardiovascular risks and to enable ongoing cardiac monitoring for patients on various therapies. AliveCor BioPharma also works with biopharmaceutical partners to leverage a robust ECG library and advanced data analytic capabilities to develop new ECG algorithms to identify patients for, or monitor patients on, their novel drug therapy. If you have a strong background in the development and execution of successful partnerships between healthcare technology companies, digital health companies, CROs and biopharma companies, we'd like to talk to you. The primary objective of the position is to sell digital clinical solutions by engaging with pharma and CRO partners to ensure that our novel devices and services are utilized within clinical trials. You will manage from end to end the entire deal-flow including lead generation, ideation of digital solutions and sales opportunities, structuring, negotiating, and executing contracts, managing the development and launch of partner programs and ongoing relationship management. You will work closely with product management when the opportunity requires AliveCor to customize or develop bespoke solutions. Job Duties and Responsibilities: Develop and manage a robust pipeline of strategic sales opportunities with biotech, pharmaceutical, and CRO (clinical research organization) partners that leverage AliveCor's ECG devices, services, capabilities and data Sales to key biopharma and CRO decision makers, including clinical development/clinical operations and digital health leaders, who can influence the use of AliveCor's products and services within their clinical trial programs Develop sales and strategic agreements with CRO partners to influence their proactive outreach to pharma sponsors to utilize AliveCor's products and services in clinical trials. You will also work directly with pharma companies not utilizing CROs Work with the Director of Cardiac Solutions on lead generation, program development, business deal terms as well as assisting in the seamless execution of our solutions within clinical trials Qualifications & Skills: Bachelor's Degree with a minimum of 8+ years of successful experience selling devices and digital solutions to biopharmaceutical companies and CROs The ideal candidate has worked in, or with, large biopharmaceutical or CRO focused on the use of technology and sensors within clinical trial programs Ideally, you will have an established list of relationships with industry clinical trial decision makers as well as experience in developing and leading successful partnerships Deep understanding of the medical device and drug development process and have significant prior experience, allowing you to “see around the corner” to develop solutions for BioPharma partners that meet stringent regulatory, legal, data security, data privacy, and clinical requirements An entrepreneurial mindset with the ability to engage directly and create new relationships, uncover key decision-makers within pharmaceutical companies whom you think may derive value from AliveCor products and services Demonstrable track record in developing long-term business relationships with CROs and pharma companies and owning high-profile client relationships Enjoys a fast-paced, startup environment and are happy to roll up your sleeves, effectively collaborate with your peers and deliver with excellence Exceptional written and verbal communication skills Ability to juggle multiple projects, client interactions and deadlines simultaneously Position is 100% remote with 10-20% travel The Perks: AliveCor offers full-time employees benefit plans including medical, dental, vision, paid vacation, paid holidays, paid personal days, volunteer time off, 401 (k) savings with employer match, bonus opportunities, life insurance, company sponsored life insurance & our KardiaComplete program. AliveCor is an equal opportunity employer and will not discriminate against any employee or applicant based on age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any other classification protected by federal, state, or local law. Principals only. Recruiters, please don't contact this job poster. Do not contact us with unsolicited services or offers.
    $94k-116k yearly est. Auto-Apply 60d+ ago
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  • Cell Culture Process Development Lead - Pivotal & Commercial

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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
    $92k-120k yearly est. 6d ago
  • Sr. CTM Associate - Oncology, Hematology or Cell Therapy

    Gilead Sciences, Inc. 4.5company rating

    Santa Monica, CA job

    We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. The Senior Clinical Trials Management Associate is a primarily an in‑house sponsor position (though some travel is required) who will oversee multiple aspects of clinical trial conduct including study start‑up, document generation and review, tracking of sample enrollment of study participants, and management of vendors. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to a Senior Clinical Trials Manager of Clinical Operations. Responsibilities Prepares and/or reviews study‑related or essential study start‑up documents as they relate to the supported clinical trials as delegated by the study manager (e.g., Clinical protocols, Informed Consent Forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form [CRFs], CRF Completion Guidelines and other relevant study plans and charters). Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met. Provides corrective instruction, as necessary, when performance expectations are not being met. Attends internal team and other meetings as required. Provides training, as necessary, at investigator meetings and other trial‑specific meetings such as site initiation visits and monthly teleconferences. Creates and reviews site feasibility assessments required for study participation. Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations. Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to Senior Manager. Prepares metrics and updates to key deliverables for management. Assists in the resolution of clinical trial queries and data review for interim analysis, primary analysis and final database locks. Prepares site newsletters and other correspondence related to clinical trial conduct (e.g., best practices and lessons learned, frequently asked questions) in collaboration with the study team. Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol. May lead less complex studies and/or manage components of more complex studies as a member of the study team. May participate in department initiatives or special projects, such as developing new tools or processes. Ability to coach less experienced colleagues in solving problems. Understands how decisions have an impact to the broader study goals. Other duties as assigned. Basic Qualifications BS/BA and 4+ years of related experience - OR - MS/MA and 2+ years of related experience Preferred Qualifications At least three years of clinical trial experience with oncology, hematology, cell therapy or related therapeutic area experience considered a plus. Multiple years of experience managing the work of external candidates. Must be willing to travel at least 25% (possibly more). Ability to manage time demands, incomplete information or unexpected events. Must display strong analytical and problem‑solving skills. Attention to detail required. Outstanding organizational skills with the ability to multi‑task and prioritize. Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment. Comfortable in a fast‑paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Working knowledge of transplant patient care and apheresis collection a plus. Salary & Benefits Salary range: $115,260.00 - $149,160.00. The 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*. * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For additional benefits information, visit ****************************************************************** About Kite Pharma Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long‑term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ******************* Sign up to follow @KitePharma on Twitter at *************************** Equal Employment Opportunity Statement Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. Additional Notices Notice: Employee Polygraph Protection Act. Your rights under the Family and Medical Leave Act. Healthy work environment: Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. Application Instructions For current Kite Pharma employees and contractors: apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0049437 #J-18808-Ljbffr
    $115.3k-149.2k yearly 3d ago
  • Associate General Counsel, Biologics (Antibodies)

    Neurocrine Biosciences 4.7company rating

    San Diego, CA job

    Associate General Counsel, Biologics page is loaded## Associate General Counsel, Biologicsremote type: On-Sitelocations: US CA San Diegotime type: Full timeposted on: Posted Yesterdayjob requisition id: R6266## Who We Are:At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.## What We Do:Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis\* and uterine fibroids,\* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit , and follow the company on , and . (*\*in collaboration with AbbVie*)## About the Role:Develops and implements key strategies to address a broad array of intellectual property matters to support the Company's US-based or Swiss- and European-based activities and programs. Works closely with other members of the Legal Department in the US and Europe and their respective clients to address intellectual property issues across multiple disciplines, including Commercial, Corporate Affairs, Research, Development, Clinical, Regulatory, Manufacturing, Medical Affairs, Business Development, and Alliance Management. Counsels clients and assists in the drafting and negotiating of complex life sciences agreements. Advises and trains business clients on intellectual property policies and procedures.\_## Your Contributions (include, but are not limited to):* Develop high level intellectual property strategy, identification of inventions, and management of patent drafting and prosecution relating to small molecule drugs or biologics and gene therapies* Provide legal advice to assigned business partners on a broad range of topics involving intellectual property* Identifying opportunities for expanding the Company's Intellectual property position and collaborating with members of various discovery, development and business groups within the Company* Working and communicating with collaborators and other external strategic partners in connection with developing a global IP strategy* Provide leadership, mentoring and coaching to attorneys, patent agents, paralegals, and/or support staff* Manage patent and IP-related contentious matters, together with internal legal staff and outside counsel* Develop and implement internal processes, procedures and training centered on intellectual property identification and protection* Work with scientific team and technical leads to identify, evaluate and protect intellectual property arising from various R&D programs* Draft, review and negotiate intellectual property provisions of manufacturing, process development, purchase, supply, license, and master service agreements* Negotiate and support other technology transactions, such as commercial in-licenses, non-disclosure agreements, material transfer agreements, testing agreements and other similar activities* Other duties as assigned## Requirements:* Juris Doctorate or similar Law Degree and PhD in organic chemistry or allied chemical discipline or in genetics, immunology, biochemistry, virology or related discipline preferred; AND 10+ years of IP experience with significant in-house and/or law firm patent experience related to biologics/gene therapy or small molecule drugs. OR* Patent Attorney currently qualified to practice before the Patent and Trademark Offices in the US or EU/UK/Switzerland AND* Recognized Internal thought leader and deep expertise in a discipline* Requires broad, deep and comprehensive expertise in leading-edge theories and techniques for functional area* Applies ingenuity and creativity to problem analysis and resolution in complicated and/or novel situations* Influences internal/external business and/or industry issues that have an impact on Neurocrine* Strong mentoring skills and leadership abilities supervise lower levels and/or leads indirect teams* Proven ability to translate strategy into tactical plans and drive outcome* A broad range of patent-related legal expertise is required, including patent preparation, development and implementation of U.S., European and broad-based global prosecution strategies, IP due diligence, strategic counseling and management of contentious IP matters with a particular emphasis on small molecule drugs or biologics and gene therapies, as well as other pharmaceutical subject matter* Extensive expertise in managing small molecule pharmaceutical exclusivity related legal matters including brand-on-brand patent litigation strategies and the aspects of regulatory affairs related to market exclusivity* Exceptional communication skills including fluency in English in conducting presentations, interpersonal interactions, written work and conflict resolution with an ability to effectively interact with Neurocrine team members at every level in the organization and across a wide range of scientific knowledge levels* Proven success with Orange Book and Patent Term Extension practice for the US and SPC is required* Ability to independently oversee legal matters, build and manage a small team of patent professionals (when and if needed), manage the use of outside legal counsel and work collaboratively with other personnel at Neurocrine* Ability to set aggressive deadlines, handle multiple complex legal matters and see projects through to conclusion* Demonstrated expertise working effectively in a global pharmaceutical company across multiple disciplines, sites and time zones.Neurocrine Biosciences is an EEO/Disability/Vets employer.We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.\_The annual base salary we reasonably expect to pay is $256,400.00-$350,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. #J-18808-Ljbffr
    $256.4k-350k yearly 5d ago
  • Associate Director/Principal Scientist

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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
    $116k-163k yearly est. 6d ago
  • Director, R&D E-Systems Quality & AI Leadership

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    A global biopharmaceutical company is seeking a Director of Quality to lead R&D quality and compliance initiatives focused on electronic systems. The role involves executing the Quality strategy, adopting emerging technologies, and collaborating across departments to enhance operational excellence. The ideal candidate will have over 13 years of experience in the pharmaceutical industry, demonstrating strong leadership and a deep understanding of quality assurance methodologies. This full-time position is based in Foster City, California, offering a competitive salary range and comprehensive benefits. #J-18808-Ljbffr
    $155k-202k yearly est. 3d ago
  • Assoc Director, Manufacturing Operational Readiness

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead Sciences 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
    $130k-167k yearly est. 6d ago
  • Senior Oncology Bioinformatics Scientist

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    A leading biotech company in Foster City is searching for a Senior Scientist with extensive experience in analyzing omics data such as RNA-Seq and WES. The ideal candidate will have a PhD and 8+ years of experience in the pharmaceutical or biotech industry, strong statistics knowledge, and excellent communication skills. Responsibilities include synthesizing scientific questions into research efforts and empowering teams to achieve organizational objectives. Join a dynamic team that values diversity and supports professional growth. #J-18808-Ljbffr
    $88k-133k yearly est. 4d ago
  • Assoc Director, Supply Chain

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    Associate Director, End-to-End Commercial Supply Planner plays a critical role developing and executing supply plans for commercial small molecule and biologics products. This role partners closely with regional commercial supply chain leads to deeply understand demand planning trends, market dynamics, and promotional activities, ensuring these inputs are fully incorporated into global supply plans. Reporting to the End-to-End Commercial Supply Chain Product Lead, the role leverages tools such as SAP ERP and Kinaxis Rapid Response to enable accurate, responsive supply planning and ensure product availability across diverse markets. Key Responsibilities Collaborative Demand-Supply Alignment Act as a primary partner to regional commercial supply chain leads to understand regional demand planning trends, market access changes, promotional campaigns, and product lifecycle events. Ensure demand signals from regional planning teams are accurately reflected and integrated into the end-to-end supply plans. Facilitate regular communication and alignment sessions with regional leads to validate assumptions, reconcile forecast discrepancies, and adjust supply plans accordingly. Supply Planning & Execution Develop, maintain, and execute detailed commercial supply plans that reflect the latest demand insights and manufacturing capacities. Utilize SAP ERP and Kinaxis RapidResponse to build and monitor supply plans, adapting quickly to changes in demand or supply constraints. Work closely with internal and external manufacturing sites to confirm production schedules support demand trends and commercial priorities. Inventory & Allocation Management Collaborate with regional supply leads to optimize inventory positions, balancing customer service levels with cost efficiency. Support supply allocation decisions during constrained supply scenarios by leveraging insights from demand trends. Cross-Functional Engagement Partner with Commercial Operations, Quality, Manufacturing, and Finance teams to ensure supply plans support overall business objectives. Participate in regional and global S&OP processes, providing supply planning expertise and demand-supply reconciliation. Support change management initiatives impacting supply plans resulting from commercial or regulatory changes Performance Monitoring & Reporting Track and report key supply planning metrics including supply plan adherence, inventory levels, and service performance. Provide timely updates and escalations to leadership and stakeholders based on supply-demand alignment. Basic Qualifications Doctorate and 5+ years of relevant experience OR Master's and 8+ years of relevant experience OR Bachelor's and 10+ years of relevant experience OR Preferred Qualifications Experience in supply planning or related roles within pharmaceutical or biopharmaceutical commercial supply chains. Proven experience partnering with regional commercial supply chain leads to incorporate demand planning insights into supply plans. Strong experience with SAP ERP and Kinaxis RapidResponse or equivalent supply planning tools. Knowledge of commercial supply chain dynamics in small molecule and/or biologics product sectors. Excellent interpersonal and communication skills to foster collaboration with regional teams. Strong analytical skills with the ability to interpret demand data and translate into executable supply plans. Ability to manage competing priorities and work effectively in a global, matrixed environment. Proactive problem-solving mindset and customer-focused approach. #J-18808-Ljbffr
    $135k-186k yearly est. 6d ago
  • Lead Backend Software Engineer

    Alivecor 4.2company rating

    Alivecor job in Mountain View, CA

    Why Join AliveCor At AliveCor, we imagine a healthier world powered by access to personalized intelligent information. We're on a mission to be the world's heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, millions of users have taken more than 300 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that we've saved lives. Join us in our mission! The Opportunity AliveCor is the most clinically validated personal ECG technology, trusted and recommended by leading cardiology practices in the United States and around the world. We value research, working in collaboration with hospitals and research groups, and supporting internal research in artificial intelligence and machine learning. The Lead Backend Software Engineer, with experience working with GoLang, Java, Docker/Kubernetes and AWS, will be an integral member of our engineering team responsible for our backend services design and implementation. Job Duties and Responsibilities: * Design and implement solutions in collaboration with product and engineering leadership * Hands-on software Engineer working in the following environment: Go, Java, Ruby on Rails, PostgreSQL, AWS, TDD/BDD with RSpec * Track record with integrating the latest AI technologies (e.g. LLMs) to greatly enhance end to end customer experience. * Responsible for developing industry-leading applications transforming the healthcare industry and consumers use. * Work with our mobile and front-end teams to build new functionality in our consumer and clinician-facing applications. * Create and maintain tools used by internal teams for customer service, monitoring, and R&D. * Maintain and continuously improve our backend infrastructure to remedy technical limitations before they become an issue. * Actively participate in development along with team members for as much as 50% of your time, creating modules & systems that can then be treated as a working reflection of best practices. * Driving code reviews, design reviews, and architecture discussions. * Experiment with new & relevant technologies and tools, and drive adoption while measuring yourself on the impact you are able to create Qualifications and Skills: * Excellent problem-solving skills for complex & large-scale problems. * Technical Breadth - Exposure to a wide variety of problem spaces, technologies. * Very strong System design skills with a nifty ability to craft clean interfaces and operate at the right levels of abstraction. * Excellent coding skills with the ability to improve coding standards across large codebases. * Deep knowledge, understanding & experience of working with a large variety of multi-tier architectures. Awareness of pitfalls & use cases for a large variety of solutions. * Deep understanding & experience of high-performance web-scale & real-time response systems with - Experience & expertise in a variety of large-scale persistent systems including large databases. * Exposure to complete product development cycles - From inception to production to scaling up, supporting new requirements, re-architectures - the Architects should have seen it all and ideally in multiple cycles. Should have been part of scalable product development cycles with either large data handling or large transaction processing exposure for 5+ years. * Hands-on software engineer with 15+ years of relevant experience * Strong experience working with Go and Java * Strong knowledge of AWS & Kubernetes * Knowledge or interest learning Ruby on Rails would be an added advantage * Experience implementing Service Oriented Architecture or Microservices * Product instincts, work with our product and design teams to understand customer pain points, come up with solutions, and then prototype, iterate, and launch frequently * Eagerness and willingness to learn new technologies * Experience with build process automation and CI/CD * Ability to work independently on projects and communicate with cross functional teams to deliver products on time
    $139k-181k yearly est. Auto-Apply 43d ago
  • Director, Global External Manufacturing, OSD

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    * Performs as a leader within Global External Manufacturing to execute the network strategy. Responsible for tactical manufacturing strategy, execution of the business with external manufacturing organizations, and management of supplier performance* Partner in development of department strategy aligned with corporate and PDM goals into functional/departmental objectives to realize the targeted outcomes* Proactively and effectively leads collaboration with functions within and external to PDM to achieve corporate, cross functional, and departmental goals* In collaboration with Technical Development Organization, defines the technical requirements and actively partners with Global Supply Chain in selection of CMOs, and influences overall performance of the network CMOs to achieve Gilead's strategic and tactical business outcomes, including Key Performance Indicators* Proactively partners with Technical Development and internal Gilead manufacturing sites for successful technology transfer and validation of new or existing processes/products to the identified CMO(s)* Leads the regular, tactical management of CMOs to ensure Gilead's products are manufactured in accordance with the registered process and approved Master Production Record* Enables timely resolution of complex issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control* Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability* May represent Gilead as a liaison between the company and various governmental agencies as required* Demonstrated track record in oral solid dosage drug product manufacturing and supply chain execution in the pharmaceutical industry* Expertise in supply risk management, possessing in-depth knowledge of industry and system best practices* Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP). Solid knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance* Solid understanding of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities and limitations for worldwide drug product manufacturing is a plus* Ability to travel internationally, including overnight, up to 10% of the time is required* Exceptional verbal and written communication skills, including ability to interact effectively with senior management* Demonstrated ability to understand and resolve complex situations* Proven leadership capability to contribute to the success of PDM and Gilead* 12+ years of progressively responsible experience in a pharmaceutical/biotech organization and a BA or BS degree in science or engineering, an advanced degree in science, engineering, or business is desirable* An MBA degree can be substituted for 10 years of relevant experience, a Ph.D. degree can be substituted for 8 years of relevant experience #J-18808-Ljbffr
    $133k-182k yearly est. 7d ago
  • Head of Data Science & Digital Transformation

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    A leading biotechnology company in California seeks an experienced leader to drive digital and data strategies in their R&D organization. The ideal candidate will bring over 12 years of experience, with a strong focus on integrating digital tools and building diverse teams. This is a pivotal role aimed at transforming workflows and enhancing organizational capabilities through advanced analytics and AI technologies. #J-18808-Ljbffr
    $122k-154k yearly est. 5d ago
  • Senior CTM Associate, Oncology & Cell Therapy

    Gilead Sciences, Inc. 4.5company rating

    Santa Monica, CA job

    A leading biopharmaceutical company in Santa Monica is seeking a Senior Clinical Trials Management Associate to oversee clinical trial operations. The role requires at least 4 years of experience in clinical trials, with a strong preference for candidates experienced in oncology or hematology. Responsibilities include managing clinical trial conduct, communication with contract research organizations, and providing training for trial staff. The position offers competitive salary and benefits, including health insurance and paid time off. #J-18808-Ljbffr
    $79k-103k yearly est. 3d ago
  • Head of Oligonucleotide Chemistry R&D & Strategy

    Neurocrine Biosciences 4.7company rating

    San Diego, CA job

    A leading biopharmaceutical company in San Diego seeks a Scientific Director for Oligonucleotide Chemistry Research. The ideal candidate will drive strategic direction for si RNA-based projects and lead a multidisciplinary team. Strong experience in oligonucleotide chemistry and proven leadership skills are required. This position offers a competitive salary and benefits, including an annual bonus and equity incentives. #J-18808-Ljbffr
    $129k-171k yearly est. 6d ago
  • SVP and GM of ICR/GPS

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    * 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
    $180k-263k yearly est. 6d ago
  • Strategic Director, Medical Affairs Evidence Generation

    Gilead Sciences, Inc. 4.5company rating

    Santa Monica, CA job

    A leading biopharmaceutical company is seeking a US Medical Senior Director to drive evidence generation strategies and lead medical oversight for clinical trials. The ideal candidate has an MD and at least five years of experience in medical affairs within the biopharmaceutical industry. Responsibilities include strategic planning, study oversight, and cross-functional collaboration to enhance cancer therapies. #J-18808-Ljbffr
    $112k-143k yearly est. 7d ago
  • Associate Director, Omnichannel Marketing: Cancer Therapy

    Gilead Sciences, Inc. 4.5company rating

    Santa Monica, CA job

    A leading biopharmaceutical company in Santa Monica seeks an Associate Director of Omnichannel Marketing. The role involves developing marketing strategies, overseeing campaigns, and ensuring a great customer experience. Ideal candidates will have 7+ years in marketing and a strong background in omnichannel approaches. Benefits, including competitive salary and stock incentives, highlight the commitment to employee well-being. #J-18808-Ljbffr
    $149k-189k yearly est. 5d ago
  • Director, PDM Infrastructure - Foster City

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    United States - California - Foster City Manufacturing Operations & Supply Chain Regular KEY RESPONSIBILITIES Reporting to th e Senior Director , Pharmaceutical Development and Manufacturing (PDM) Operations Management , the Director , PDM Infrastructure will lead the team responsible for the key non-GMP systems that have an outsized impact on how we store, find and access non-GMP information in PDM. SharePoint ( G.Share ) and PDM apps like the PDM Team Rostering application ( G.Force ) will the initial areas of focus. PDM has generated a great deal of important non-GMP information ; being able to find and access such information easily and consistently across PDM will improve efficiency and speed . Success in this role depends on ongoing solicitation of feedback from PDM stakeholders and continuous improvement . FOCUS AREA S Lead the G.Share Sites and G.Share Business Apps teams Assess and prioritize current non-GMP infrastructure for knowledge sharing and identify areas for continuous improvement Serve as a member of the PDM Operations Management Leadership Team , connecting work that the PDM Infrastructure team does with the broader PDM Operations Management strategy Implement strategy and plan for enabling more efficient and consistent access to non-GMP information across PDM , making it easier and more efficient for PDM staff to get their work done Work effectively with partners in I T, with clearly defined roles & responsibilities. This role is not a technical systems role; it is the business side of information infrastructure and access BASIC QUALIFICATIONS: A degree in life sciences or a relevant business area with 12+ years of varied post-graduation experience in Pharmaceuticals, Biosciences or a related industry. Or MS with 10+ years of relevant experience. Or PhD with 8+ years of relevant experience. Strong business acumen, with demonstrated capability to translate information infrastructure to improved efficiency Strong experience with SharePoint and web-based information storage and access Demonstrated capability to navigate and lead in a highly networked environment and experienced with the required elevated level of influencing skills. Elevated communication skills, both written and oral. Strong presenter capable of engaging with, and facilitating conversations with, the senior leaders in the organization. Negotiation and conflict resolution skills. Experience developing, implementing, and executing strategic plans and objectives for departments, especially in a highly networked environment. Solid understanding of current industry trends. Experience leading a non-technical team that interfaces with technical teams Leadership qualities of the successful candidate include the following: collaboration, accountability, cross-functional engagement and influence, program management, strategic vision, goal setting and performance management. PREFERRED QUALIFICATIONS: Demonstrated capacity to understand complex problems and to implement solutions that are as simple as possible. Experience with knowledge management 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 R0046747 Full Time/Part Time Full-Time Job Level Director #J-18808-Ljbffr
    $165k-234k yearly est. 6d ago
  • Director, Comparator Sourcing, Global Clinical Supply Chain (GCSC)

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    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
    $158k-212k yearly est. 7d ago
  • Executive Director, HIV Treatment Marketing

    Gilead Sciences, Inc. 4.5company rating

    Foster City, CA job

    * 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 #J-18808-Ljbffr
    $151k-206k yearly est. 5d ago

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