Cytokinetics jobs in San Francisco, CA - 1088 jobs

Senior Director, Legal Counsel page is loaded## Senior Director, Legal Counsellocations: South San Francisco, Californiatime type: Full timeposted on: Posted 30+ Days Agojob requisition id: R274Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.**Responsibilities*** This role is expected to have critical understanding of complex contracts and strong knowledge of key provisions of such agreements such as indemnities, limitations of liability, intellectual property, warranties and covenants, regulatory, termination and other critical contract negotiation issues.* Agreements will include indentures, lease agreements, clinical trial agreements, pharmaceutical license agreements, master service agreements, software license agreements and supply and wholesaler arrangements.* Lead certain general corporate contracts - drafting, negotiating and reviewing certain corporate contracts, as needed and knowledge of contract-related systems.* Independently provide leadership on cross-functional teams, identify legal issues, provide legal options and analysis of possible legal solutions, and give recommendations for addressing critical issues so that business and legal objectives are met.* May also provide support and advice to G&A departments and investor relations.* Manage outside counsel effectively and efficiently, and consistent with applicable budgets. Work creatively with outside counsel to minimize fees and costs.**Qualifications*** JD degree* Admitted to at least one state bar. Admitted to California bar or admitted as Registered In-House Counsel in California is a plus* Minimum of 10 years of experience as in-house counsel in a biotechnology, pharma or healthcare company or a combination of in-house at large public company and/or nationally recognized law firm specializing in the area of interest* Strong working knowledge of U.S. securities laws and NASDAQ requirements. Experience with securities filings of public companies in the life science industry or strong experience in completing public Merger and Acquisition activities* Detailed-oriented with a high level of intellectual, professional and interpersonal agility and flexibility, combined with strong analytical and problem-solving skills* A sophisticated existing understanding of financial regulations* An ability to operate independently* Excellent communication skills, both oral and written* Intellectual curiosity and a willingness to take responsibility for novel and emerging areas of regulation* Well-organized and hardworking, with the ability to manage numerous projects simultaneously under deadline pressure* Excellent analytical skills, with a strong ability to draft and review legal documents, analyze legal advice and apply legal advice to business needs* Ability to form strong working relationships with all levels of management, employees, and partners while maintaining firm adherence to proper legal standards* Team-oriented, sound judgment, self-motivation and willingness to take initiative#LI-HYBRID**Pay Range:**In the U.S., the hiring pay range for fully qualified candidates is $333,000 - $368,000 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.*Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.***Please review our PRIOR to applying.**Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.Here are some ways to check for authenticity:* We do not conduct job interviews through non-standard text messaging applications* We will never request personal information such as banking details until after an official offer has been accepted and verified* We will never request that you purchase equipment or other items when interviewing or hiring* If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at ************************************Please visit our website at:****Cytokinetics is an Equal Opportunity Employer** #J-18808-Ljbffr

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

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

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

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 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

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.The Associate Director of Operational Excellence (OpEx) is a key leadership role responsible for driving end-to-end process improvement, operational efficiency, and organizational capability building across Supply Chain, External Manufacturing, and Technical Operations within the pharmaceutical manufacturing network. This role will partner with internal and external stakeholders to deliver transformational initiatives, ensure robust supply performance, and enhance the company's ability to deliver high-quality medicines to patients reliably and cost-effectively.The ideal candidate brings expertise in Lean Six Sigma, pharmaceutical manufacturing processes (including cGMP), and the unique challenges of managing a global external manufacturing and supply network.**Responsibilities****Lead Operational Excellence Strategy & Execution*** Develop and execute the Operational Excellence roadmap for Supply Chain, External Manufacturing, and Technical Operations, aligned with business goals and priorities.* Drive transformational initiatives that enhance reliability, agility, and cost-effectiveness of the end-to-end supply network.* Embed a culture of continuous improvement across internal teams and external partners.* Monitor industry trends and benchmark performance to sustain competitive advantage in operational practices.**Process Improvement & Performance Optimization*** Identify, prioritize, and implement process improvement opportunities to enhance service, reduce costs, and ensure compliance across planning, sourcing, manufacturing, and distribution.* Facilitate cross-functional projects using Lean, Six Sigma, Value Stream Mapping, and other proven methodologies.* Support Technical Operations in problem-solving initiatives by coaching team leads to effectively utilize fit-for-purpose frameworks for identifying root cause(s).* Standardize and digitize key supply chain and manufacturing processes to improve visibility, control, and decision-making.**External Manufacturing & Supplier Excellence*** Collaborate with CMOs/CDMOs and internal stakeholders to assess and improve external manufacturing performance through systematic KPI reviews and improvement plans.* Lead joint improvement initiatives with external partners while ensuring cGMP and regulatory compliance.* Build strong relationships and foster a culture of collaboration and continuous improvement with suppliers and contract manufacturers.**Tier Management & Visual Performance Management*** Design, implement, and sustain a Tiered Management System (Tier 1-3) across Supply Chain, External Manufacturing, and Technical Operations to enable effective daily, weekly, and monthly performance management.* Deploy visual management tools and performance dashboards at each tier level to drive accountability, transparency, and fast problem resolution.* Train and coach teams and partners in daily management practices, visual controls, and structured problem-solving.* Ensure escalation processes and feedback loops are effective and standardized across the network.**Capability Building & Change Leadership*** Build organizational capabilities by developing and delivering training on Operational Excellence tools and methodologies to internal teams and external partners.* Coach functional and site leaders in OpEx mindset and practices to enable self-sufficiency and sustained improvements.* Lead change management efforts to overcome resistance and embed new ways of working.* Act as a role model for continuous improvement, demonstrating a data-driven, collaborative, and solution-oriented approach.**Qualifications & Experience*** Bachelor's degree in Engineering, Supply Chain Management, Life Sciences, or related field required; Master's degree or MBA preferred.* Minimum 8-10 years of experience in a regulated healthcare industry segment (e.g., pharmaceutical development, supply chain, manufacturing, medical device, or technical operations, with at least 3-5 years in operational excellence, continuous improvement, or similar leadership roles.* Strong understanding of manufacturing and supply chain processes, cGMP, regulatory requirements, and the complexities of external manufacturing.* Certified Lean Six Sigma Black Belt (or equivalent) strongly preferred.* Proven track record of delivering measurable improvements in operational performance, cost reduction, and process efficiency.* Experience managing and improving external manufacturing or supplier relationships in a regulated industry.* Exceptional project management, change management, and facilitation skills.* Excellent communication, influencing, and stakeholder management abilities across all organizational levels and with external partners.* Ability to thrive in a fast-paced, matrixed, and global environment.**Competencies*** Strategic thinking with a hands-on approach.* Results-oriented and data-driven decision-making.* Strong analytical and problem-solving skills.* Ability to lead without authority and drive collaboration.* Passion for excellence and continuous improvement.**Pay Range:**In the U.S., the hiring pay range for fully qualified candidates is $189,900-$221,550 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.*Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.***Please review our PRIOR to applying.**Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.Here are some ways to check for authenticity:* We do not conduct job interviews through non-standard text messaging applications* We will never request personal information such as banking details until after an official offer has been accepted and verified* We will never request that you purchase equipment or other items when interviewing or hiring* If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at ************************************Please visit our website at:****Cytokinetics is an Equal Opportunity Employer** #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

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

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact. The Associate Director, Medical Communications will oversee a core medical function providing accurate, unbiased, balanced and timely response to unsolicited medical inquiries regarding Cytokinetics marketed and pipeline products from HCPs and consumers, clinical sites and managed care organizations, requests submitted by field Medical and Commercial teams, and MI inquiries escalated from affiliates. The Associate Director, Medical Information will be responsible for managing the operational and tactical execution of Cytokinetics' Medical Information capabilities in US and partner with global/regional leads to develop global core content. They play a critical role in ensuring that medical content is scientifically balanced, evidence-based, current and fair-balanced, and meets the scientific needs of medical community to help inform clinical care, formulary access decisions and other strategies which can have significant impact on the appropriate use of Cytokinetics' medicines. Key Responsibilities Serve as product information expert and interface with internal and external Customers to provide concise, accurate, and non-promotional responses to medical information requests in a timely manner Responsible for implementation of the Medical Information plan across Cytokinetics' product portfolio Partner cross-functionally across Medical Affairs, Commercial, Pharmacovigilance, Regulatory, and Compliance to support strategic initiatives including launch readiness, lifecycle management, congress planning and field enablement Deliver Medical Information training to internal teams (eg, field medical, sales) and contact center staff Monitor and analyze inquiry trends, metrics, and insights to inform Medical Affairs strategies and resource development Collaborate with internal teams to ensure appropriate staffing, training, and operational support of Medical booth at key scientific meetings Lead the development, review, and maintenance of global core content, including database of standard response letters (SRLs), FAQs, and custom response documents for rapid and consistent dissemination of product data across multiple regions Collaborate with US and European medical information stakeholders to ensure maximal global utility of medical information assets and support content translation, adaptation, development, and version control Monitor the medical literature and interpret emerging scientific and clinical data to ensure that all Medical Information content is current, accurate, and balanced Oversee the US Medical Information Contact Center and ensure timely, accurate, and compliant handling of inquiries Conduct routine quality assurance reviews of contact center responses and implement corrective actions or retraining as needed Ensure appropriate documentation and follow-up of safety-related inquiries in collaboration with Pharmacovigilance in line with regulatory requirements in all required regions Drive continuous improvement by identifying gaps and opportunities in Medical Information operations, systems, and content Contribute to the development and revision of cross-regional SOPs, work instructions, and operational guidelines Track and manage Medical Information budgets, resources, and vendor relationships Qualifications Advanced life science degree (PharmD, PhD or similar) 5 or more years of experience in medical writing, medical information/drug information, and/or relevant clinical experience, may include post-doctoral training (eg, PharmD fellowship, clinical residency with drug information component) in Medical Information, Medical Affairs, or comparable industry experience Demonstrable medical writing ability and the ability to independently conduct literature searches, critically evaluate literature and summarize clinical and scientific data Exhibits advanced knowledge of Medical Information processes as well as comprehensive understanding of other internal stakeholders, including experience with medical, regulatory, legal review processes Strong knowledge of applicable regulatory guidelines and standards (FDA, PhRMA, EFPIA, etc.) Excellent interpersonal, analytical, and communications (verbal and written) skills and keen attention to detail Demonstrated strong project management experience, including excellent planning, organization and time management skills and the ability to support and prioritize multiple projects of high quality with minimal supervision Advanced proficiency with computer and software applications (MS Word, PowerPoint) and Medical Information systems used for information requests and content management Proficiency at searching multiple medical literature databases (Pubmed, Embase, etc.) and reference management software (EndNote) On-site in South San Francisco preferred Approximately 10%-20% travel anticipated #LI-ONSITE Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $195,900-$228,500 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you. Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying. Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves. Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process. Here are some ways to check for authenticity: We do not conduct job interviews through non-standard text messaging applications We will never request personal information such as banking details until after an official offer has been accepted and verified We will never request that you purchase equipment or other items when interviewing or hiring If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at ********************************** Please visit our website at: ******************** Cytokinetics is an Equal Opportunity Employer

* 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

A global healthcare leader is seeking a Senior Medical Science Liaison in San Francisco to provide scientific support and engage with healthcare professionals. This role requires strong scientific acumen and at least 3 years of experience in the therapeutic area. The Sr. MSL will build external relationships, develop strategic plans, and may travel up to 80%. If you are passionate about enhancing patient care and have relevant qualifications, apply to drive innovations in immunology. #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

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

* 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

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact. We seek a highly motivated Postdoctoral Fellow to join our research team in South San Francisco to explore new and exciting areas of muscle biology. In general, Cytokinetics postdoctoral fellows can work with their mentor to fully develop their independent research project while also learning about the drug discovery process, gaining foundational knowledge in target discovery, technology or model development, and mechanism of action of therapeutics. Our goal is to train the next generation of scientists poised to enter the biotech or academic research communities to aid the mission of discovering new medicines for muscle-related human diseases. Job purpose (what we will do for the postdoctoral fellow) Provide a postdoctoral research experience through impactful, mentored research that lays the foundation for a career in biotech or academia Provide enrichment in communication, leadership, and laboratory management Bestow foundational knowledge of the drug discovery and development process Cultivate a broad scientific network in biotech and academia Responsibilities (what the postdoctoral fellow will do for Cytokinetics) The fellow will spearhead a computational biology project to harmonize multi-modal clinical and imaging data across the UK Biobank and All of Us population biobanks related to human skeletal muscle function. Machine learning and deep learning approaches will be employed to categorize skeletal muscle phenotypes that can then be correlated to genetic variation, validated with clinical disease diagnosis and severity scores. The fellow will work collaboratively with their research mentor with the goal of generating a high impact publication on creation of this new tool. The fellow will play an integral role in championing new bioinformatic tools and workflows that enable discovery of novel therapeutic targets for drug discovery and will conduct research both independently and in a collaborative team-based setting. As a key team member, the candidate will provide regular project updates and progress in small and large group settings and provide scientific and technical expertise to advance discovery programs. Qualifications PhD in computational biology, computer science, bioinformatics, human genetics, or related field Demonstrated expertise in multidimensional data analysis Previous experience analyzing multimodal data from population biobanks such as UK Biobank, All of Us, FinnGen or Genomics England is highly desired Proven experience applying AI/ML techniques to biological problems (whether through academic research or personal side projects) is highly valued Well-articulated career goals in research (biotech or academia) Track record for research excellence, independent critical thinking, and the ability to design, execute, and interpret experiments as demonstrated by high quality publications, presentations, fellowship, and grants Enthusiasm for working in a team-based, multi-disciplinary environment, paired with excellent verbal and written communication skills Clear commitment to a rigorous 1-2 year research and enrichment program that includes stipend for travel to a scientific conference and external training/coursework beyond the career training received from mentors and colleagues. Application Process Each application should include: NIH Biosketch (see ************************************************************************************************************* for formatting instructions) Cover letter (1-2 pages) that includes the following: (A) Summary of research accomplishments, (B) Proposed career path, (C) How a 1-2-year Cytokinetics postdoctoral experience will prepare you for your career path #LI-ONSITE Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $85,000-$100,000 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you. Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying. Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves. Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process. Here are some ways to check for authenticity: We do not conduct job interviews through non-standard text messaging applications We will never request personal information such as banking details until after an official offer has been accepted and verified We will never request that you purchase equipment or other items when interviewing or hiring If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at ********************************** Please visit our website at: ******************** Cytokinetics is an Equal Opportunity Employer

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

**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