Denali Therapeutics jobs - 22 jobs

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. Lead supply chain strategy for Denali's clinical products, including demand and supply planning, IRT strategy, and production management. Act as the primary supply chain contact, support Direct-to-Patient strategy, collaborate cross-functionally, troubleshoot issues, and communicate program status to stakeholders. Key Accountabilities/Core Job Responsibilities: * Act as Supply Chain Lead for Denali's clinical products including developing the supply chain strategy, demand and supply planning, and IRT strategy development * Execute scenario plans and develop recommended production and inventory management strategies * Serve as primary supply chain contact with internal and external stakeholders * Support Direct-to-Patient supply chain strategy development and execution * Work cross-functionally with CMC, Development, and Finance departments to support program development * Proactively identify and troubleshoot issues to prevent missed timelines * Communicate program status both verbally and through written documents and reports * Drive continuous operational performance improvement efforts * Lead supply chain business process development projects * Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement. (if applicable) Qualifications/Skills: ● Bachelor's degree in Industrial Engineering/Operations/Supply Chain or related field; MBA strongly preferred ● 5+ years experience in clinical supply chain planning in the Life Sciences. ● Experience leading business process definition/improvement is strongly preferred ● Skilled in using influence management to drive project success ● Demonstrated ability to work accurately, meet timelines and handle multiple priorities ● Capable of responding flexibly to changing prioritization in a dynamic environment ● Strong interpersonal skills and ability to work with others in a positive "can do" and collaborative manner ● Strong verbal and written communication skills ● Advanced analytical capabilities with proficiency in Excel, Word, and PowerPoint ● Requires working knowledge of cGMP and regulations applicable to the FDA and comparable international regulatory agencies Salary Range: $152,000.00 to $185,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. We are seeking a Director of Data Science across Commercial, Medical Affairs, and Patient Advocacy (CMPA), who will play a pivotal role in Denali's commercialization efforts by enabling strategic decision-making, utilizing advanced data analytics and machine learning techniques to optimize commercial performance. This individual will work cross-functionally to develop the roadmap and strategic application of data science (inclusive of predictive analytics, artificial intelligence and machine learning). This individual will be responsible for turning complex datasets into actionable insights that enhance the company's go to market strategies, omni-channel efforts, improve market access, and drive revenue growth. This role combines the application of data science with a strong understanding of the biotech industry, commercialization, market dynamics, and customer behavior. The ideal candidate is comfortable working with large, multifaceted datasets, leveraging statistical models, and communicating findings clearly and compellingly to non-technical stakeholders. Key Accountabilities/Core Job Responsibilities: Cross-Functional Collaboration & Strategic Leadership: * Work with a diverse set of stakeholders, including marketing, market access, global product strategy, medical affairs, and sales teams to understand business objectives in order to develop the roadmap and strategic application of data science (inclusive of predictive analytics, artificial intelligence/machine learning). * Provide data-driven insights and strategic recommendations to support commercialization efforts. Data Analysis & Reporting: * Develop and maintain advanced analytical models to support commercial decision-making to inform Denali's go-to market strategies, identify opportunities to enhance and elevate customer and patient experiences, improve market access, and drive revenue growth. * Analyze and interpret large datasets (e.g., sales, CRM, marketing, financial) to uncover insights and provide actionable recommendations to cross-functional teams. * Design and execute A/B tests, experimentations, and customer behavior analysis to assess the effectiveness of commercial strategies and identify opportunities to refine commercial approach. Predictive Modeling, Machine Learning, and AI: * Apply machine learning and statistical modeling techniques to predict trends, customer behavior, market dynamics, and sales performance. * Build and refine predictive models to assist in local sales planning, market opportunity identification, and resource allocation. * Utilize advanced algorithms to optimize field teams' (MSLs, salesforce) effectiveness and identify high-value customers or market segments. * Identify opportunities to leverage AI to automate work, such as competitive intelligence monitoring, synthe sizing insights from field and market research, etc. Visualization & Communication: * Create and present clear, compelling visualizations and reports to senior leadership, translating complex data analyses into actionable insights and business strategies. * Provide regular updates and strategic recommendations based on data trends and performance metrics. Tool Development & Automation: * Develop and implement automated reporting solutions to enhance the efficiency of operations. * Work with IT and data engineering teams to ensure data pipelines, tools, and dashboards are efficient, scalable, and aligned with commercial needs. Qualifications/Skills: * Bachelor's degree in Marketing, Business, Life Sciences, or a related field. * 10+ years of relevant work experience, including 8+ years in data science or advanced analytics, with a focus on commercial applications in the biotechnology or pharmaceutical industry; specific experience in patient and access marketing is preferred. * Strong understanding of biotech or pharmaceutical market dynamics, patient access, healthcare system intricacies, and regulatory requirements. * Ability to develop and implement strategic marketing initiatives, with a data-driven approach and strong analytical skills. * Excellent verbal and written communication skills, with the ability to convey complex information clearly and empathetically to patients and healthcare providers. * Proven ability to work effectively across functions and lead collaborative initiatives with internal and external stakeholders. * Exceptional organizational skills with experience managing multiple projects, timelines, and priorities in a fast-paced environment. Salary Range: $226,000.00 to $267,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases. Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely. Summary: Responsible for leading in the development, implementation and maintenance of QA systems and activities supporting quality oversight towards GCP, GLP, and PV operations. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols. The incumbent is also responsible for developing specific internal procedures, training of staff, and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with Company's functional areas. The candidate will perform audits of service providers, study sites, and internal processes. The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP, PV, and GLP focused team settings and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of Company's clinical stakeholders and act as a catalyst for continuous process improvement. Responsibilities: Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws. Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements. Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline. Plan and oversee activities in support of regulatory submissions and inspections; Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI). Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines. Quality Management System (QMS): Maintain and enhance Caribou's QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle. Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders. Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical development and operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation. Build training and approve curricula based on the key elements of the Quality System; Provide leadership and oversight for training programs related to pre-clinical, clinical and PV. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures. Establish and monitor quality metrics and key performance indicators for the effectiveness of pre-clinical, clinical, and PV quality assurance activities. Prepare routine reports and presentations for senior/executive management review highlighting quality performance, trends, and areas for improvement. Assist with tracking compliance audit trends and present to management. Collaborate with cross-functional teams, including pre-clinical, clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of quality assurance activities. Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and service providers. Perform internal and external audits to ensure stakeholder system compliance with existing policies and procedures, and requirements, standards, and guidelines. Lead and/or manage additional Quality Assurance (GxP) initiatives or programs as business needs evolve. Qualifications: Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline with at least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry. Experience working in biologics is strongly preferred. Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research. Proven track record in developing and implementing quality systems and processes in a clinical setting. Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits. Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards. Prior GLP experience with quality oversight and auditing studies/vendors (preferred). Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for quality and regulatory compliance. The position requires a highly diplomatic, and tactful individual with excellent critical reasoning skills. Conscientiously detail-oriented and organized, impeccable attention to data review. Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways. Must be flexible and able to multi-task, prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks. Detail-oriented mindset with a proactive approach to problem-solving and decision-making. Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable. Ability to travel up to 25-30% based on business needs. Caribou compensation and benefits include: Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees Salary Range: $220,000 to $235,000- This represents the present low and high end of the Company's pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance. Generous paid vacation time, in addition to company-observed holidays Excellent medical, dental, and vision insurance 401(k) retirement savings plan, which includes matching employer contributions Employee stock purchase plan (ESPP) Tuition reimbursement program The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws. Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Senior Scientist in Clinical Pharmacology will develop clinical pharmacology and modeling and simulation (M&S) strategies for biotherapeutic and small molecule programs, guide project teams from early development through late-stage clinical trials and regulatory submissions. This role involves designing and executing clinical studies, analyzing pharmacokinetic (PK)/pharmacodynamic (PD) data, and collaborating with cross-functional teams to advance therapies for neurodegenerative diseases. This role is within the Quantitative and Clinical Pharmacology (QCP) team within the Development Sciences function. Key Accountabilities/Core Job Responsibilities: Develop Clinical Pharmacology and M&S strategies for multiple biotherapeutics and small molecule programs from pre-IND through late-stage clinical studies, including pivotal Phase 2/3 trials and NDA/MAA/BLA submissions. Develop clinical study designs and write study protocols, amendments, and reports that meet regulatory standards and project timelines with minimal supervision. Conduct hands-on pharmacokinetic (PK) and pharmacodynamic (PD) data analysis using advanced tools and methodologies to support clinical decision-making. Analyze, interpret, and communicate PK/PD data to project teams, senior leadership, and regulatory authorities. Author and review sections of regulatory submissions, including IND/CTA and NDA/MAA/BLA filings. Qualifications/Skills: PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or related scientific discipline with 5+ years experience in Clinical Pharmacology and drug development; may include relevant postdoctoral experience. Proficiency in quantitative PK/PD data analysis tools (e.g., Phoenix WinNonlin, population PK analysis, exposure-response analysis, and/or PBPK modeling). Experience in developing Clinical Pharmacology and M&S strategies, with biotherapeutics experience preferred. Strong analytical and communication skills for presenting complex PK/PD data. Proven ability to collaborate effectively on cross-functional teams. Background in neuroscience indications and/or oligonucleotide drug development preferred. Salary Range: $142,000.00 to $198,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. Serve as a strategic advisor and project manager, collaborating with leadership and cross-functional partners to ensure alignment with corporate goals and strategic priorities. Manage and facilitate key initiatives, track progress, and provide informed solutions to drive successful outcomes Key Accountabilities/Core Job Responsibilities: Act as "thought partner,” to the CSO, discovery leadership, Early Denali Portfolio Leadership (DPL) and Cross-Functional Partners (e.g., Finance, HR) for both internal and external activities Partner with Chief People Officer and General Counsel for business operations Facilitate and manage a broad range of projects to help ensure attainment of strategic priorities consistent with corporate goals Work with leadership team members individually and collectively on key business projects Ensure that key initiatives in support of Denali's goals are on track, intervening as appropriate to ensure meeting goals. Monitor and report progress to CSO, CTO, and GC,triaging and escalating issues as appropriate Work with the leadership team and others to translate strategy into deliverables that can be measured and managed Support the development and preparation of executive-level presentations Identify and prioritize key issues early and expedite resolution by integrating information search, analysis and evaluation to provide an informed perspective and propose solutions Effectively prioritize multiple objectives, monitor progress of ongoing activities and implement course corrections as needed using project management and business improvement capabilities Organize and drive the rhythm of decision making and outputs to feed in to key meetings and initiatives Track key initiatives by monitoring progress towards meeting goals, ensuring follow-through on the part of relevant players and sustaining momentum needed to drive these initiatives Influence appropriate stakeholders and ensure appropriate prioritization and project management to support the business in meeting their objectives Develop agendas, manage meeting flow, summarize and follow-up on actions to ensure timely execution Draft and minute key discussion points for Discovery, Technical Operations, and Legal strategy meetings Qualifications/Skills: BS/MS in a scientific discipline with life sciences experience preferred 7+ years of experience in project management Proven experience in Knowledge Management, Communication, Strategy/Planning Industry exp: Pharma, Biotech, Life Sciences Advanced skills in Microsoft Office suite, particularly with PowerPoint and Excel Can do attitude and analytic problem-solving skills Ability to anticipate and remediate problems that arise Strong interpersonal skills Capable of conveying scientific information in a clear and thorough manner Highly developed verbal and written communication skills, with a demonstrated ability to compose concise, sensitive and professional emails Team oriented, highly motivated, execution focused with strong work ethic, ability to thrive in a high growth, collaborative, entrepreneurial environment Highly adaptable and responsive to technical and business opportunities and needs - comfortable delivering against challenging commitments Willingness to work hard and take direction and also anticipate problems and their solutions without explicit guidance Salary Range: $0.00 to $0.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. We are seeking a talented and experienced scientist to develop, optimize, and establish state-of-the-art potency assays for our diverse pipeline of large molecule biotherapeutics. The ideal candidate should have hands-on experience in ligand-based and cell-based bioassays to characterize activity and potency of a variety of modalities including antibodies and Fc-fusion proteins as well as potentially oligonucleotide-conjugates and virus-based gene therapies. The candidate will join a broader process development group with opportunities to closely collaborate on all aspects of analytical, formulation, and process development. Key Accountabilities/Core Job Responsibilities: Lead the design, development, and optimization of cell-based and biochemical bioassays to evaluate the potency and activity of therapeutic products Developing, optimizing, and qualifying bioassays for product release and stability testing as well as supporting bioprocess and formulation development, and product characterization activities. Serve as subject matter expert (SME) for potency assays, promoting innovation and exploring novel approaches for developing and troubleshooting complex assays. Maintaining complete and accurate records and contribute to continuing process improvement. Representing the Bioassay team cross-functionally and continuously drive Bioassay method development through internal and external collaborations. Presenting experimental results in team meetings. Detailed recording and analysis of experiments in an electronic laboratory notebook (ELN) Coordinating parallel tasks across multiple projects and prioritizing deliverables to meet departmental and organizational goals. Qualifications/Skills: B.S./M.S. in relevant scientific discipline with a minimum of 5 years of direct CMC bioassay development experience in biotech/biopharma or Ph.D. with 1+ years of directly relevant experience Direct experience developing and optimizing binding and functional cell-based bioassays using platforms such as ELISA, HTRF, DELFIA, or qPCR to measure target engagement, cellular uptake, and transcript-level modulation. Demonstrated expertise in phase-appropriate assay transfer, qualification, and validation within a CMC and GMP-regulated environment. Strong understanding of regulatory expectations for bioassay development and validation (e.g., ICH Q2(R2), USP). Demonstrated ability to independently design experiments and resolve technical challenges. Innovative mindset, with experience introducing new technologies and process improvements in bioassay development. Proficient with electronic lab notebooks and analytical or statistical software (GraphPad Prism, SoftMax Pro, PLA 3.0, JMP) is essential. Adept at managing competing priorities and thriving in a fast-paced, dynamic environment. Excellent laboratory, analytical, and organizational skills, with strong critical thinking and problem-solving ability. Exceptional oral and written communication skills. Motivated, detail-oriented, and intellectually curious scientist with a creative approach to problem solving and a deep commitment to improving the lives of patients with neurodegenerative diseases. Salary Range: $125,000.00 to $158,333.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Senior. Director, Medical Information will play a key role in building comprehensive medical information capabilities to ensure provision of accurate, balanced and timely scientific information to healthcare professionals, patients, and internal stakeholders. The ideal candidate will have experience with product launches, particularly in rare pediatric diseases. Key Accountabilities/Core Job Responsibilities: * Define and drive the vision for Medical Information, including global medical inquiry management for Denali's products. * Provide oversight for the Med Info call center to ensure quality, efficiency, scalability, and compliance. * Oversee the writing and quality of standard response documents (SRDs) and FAQs for the call center and facilitate the review, approval and maintenance of these documents. * Manage medical inquiry insights reporting with consistent visualization of trends/metrics * Manage budgets and forecast functional spend * Monitor emerging scientific data and competitor activity to keep medical information materials current. * Ensure Medical Information responses and processes are compliant with global regulatory requirements, industry guidelines, and Denali policies. * Collaborate with cross-functional teams to deliver training on medical information processes, resources, and best practices. * Serve as the medical information reviewer for medical and commercial review committees to ensure that medical information is accurate and scientifically balanced. * Represent Medical Information on cross-functional projects and during audits/inspections as needed. * Perform other Medical Information-related support and expanded functions, as required Qualifications/Skills: * Doctorate level degree in scientific discipline required (PharmD, PhD, MD, or equivalent) * At or near 12 years' experience in biotech/pharmaceutical industry with at least 7 years of relevant experience in Medical Information * Experience with product launches, particularly rare pediatric diseases preferred * Specialty training in rare disease and/or neuroscience preferred * Strong knowledge of global regulatory guidelines governing medical information activities. * Excellent communication and presentation skills with the ability to effectively translate complex scientific data for diverse audiences. * Proficiency in medical literature evaluation, database management, and medical information systems. * Strong analytical and problem-solving skills with attention to detail and the ability to synthesize data into meaningful communications. * Proven experience implementing or overseeing Med Info call center operations * Ability to thrive in a fast-paced environment, manage multiple priorities, and adapt to changing business needs. Salary Range: $248,000.00 to $277,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Fate Therapeutics is seeking a motivated and execution-driven Manager/Senior Manager to support GMP manufacturing operations of iPSC-derived allogenic cell therapy products. As an integral part of the Manufacturing Team, this role is responsible for overseeing operational execution in addition to managing manufacturing quality events including deviations, CAPAs, and other required change actions. This individual will play a pivotal role in defining and executing the company's operational strategy to enable the execution of a sustainable, scalable and GMP compliant manufacturing process. Accordingly, this role will require proven leadership abilities to drive meaningful communication, collaboration and coordination both internally within the Manufacturing department as well as cross-functionally across all levels of the organization. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA. Responsibilities Responsible for overseeing end-to-end GMP production of iPSC-based drug product from media preparation and thaw of MCB's through harvest and cryopreservation of drug product. Work effectively with other groups including Quality Assurance, Supply Chain, Quality Control, MSAT, Process Development, and Facilities. Coordinate with applicable departments to manage Deviations, CAPAs, Continuous Improvements, Impact Assessments and Change Actions. Assure manufacturing facility is maintained in an inspection-ready state at all times. Engage with Materials Management and Planning and Sourcing teams to assure adequate inventory of raw materials to support planned production activities. Project management utilizing tools including but not limited to SmartSheet and Microsoft Office tools. Assure manufacturing staff meet and maintain cGMP training requirements. Develop personnel schedules to allow effective execution of manufacturing activities. Review and approve applicable manufacturing-related documentation. Lead authorship and review process of SOPs and GMP BRs. Identify potential process improvements for Manufacturing and design appropriate experiments to evaluate and implement those changes. May hire, oversee, train, and motivate team members, ensuring that team goals are met efficiently. Qualifications Bachelor's or Master's degree in a relevant discipline with 6+ years of Life Science GMP Manufacturing experience is required. A strong manufacturing administration background specifically related to tech transfer of aseptically produced cell products is preferred. A strong emphasis on quality event management and process improvement for manufacturing operations Ability to create, read, review, and edit manufacturing related documents including Batch Records, SOP's, Work Instructions and associated forms. Self-motivated, flexible, able to prioritize, multi-task, and work in a fast-paced & dynamic environment. Experience leading projects and managing teams is required. Working Conditions Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. Will require working with cells and cell lines of human and/or animal origin. Will require working with hazardous materials. Will require work in controlled and cGMP Manufacturing environments requiring special gowning. Compensation The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location. Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package. The anticipated salary range for this role is $110,000 - $150,000. The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. Equal Employment OpportunityFate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. Privacy NoticeTo learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice. About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company's pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit ************************* ⚠️ Recruitment Fraud Alert Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker's personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams. Here are a few things to be aware of to help identify recruitment fraud:- Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain.- At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.- We will only ask for personal information when applying for a position via our Careers page or thereafter.- At no stage during our hiring process will we ask you to click a link to begin a one-way video interview.- We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews. Please exercise caution. If something feels off about your interactions, we encourage you to contact us at **************************** to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This position develops, optimizes, and establishes state-of-the-art potency assays for our diverse pipeline of large molecule biotherapeutics with ligand-based and cell-based bioassays to characterize activity and potency of a variety of modalities including antibodies and Fc-fusion proteins as well as oligonucleotide-conjugates and virus-based gene therapies. Key Accountabilities/Core Job Responsibilities: Independently perform bioassays to support cell and plate-based (ELISA, ENZYME ACTIVITY) development for late stage molecule Assist in the development, optimization, and qualification of assays for product release and stability testing as well as characterization of biological activity. Support study sample testing, analysis and maintain complete and accurate records and contribute to continuing process improvement Evaluate, characterize, and document critical reagents to meet QC standards Coordinate parallel tasks across multiple projects and prioritize deliverables to meet departmental and organizational goals. Promote innovation and explore novel analytical techniques or technology. Qualifications/Skills: BS with 3+ years of industry experience or an MS 1+ years relevant experience in the industry Experience in developing and optimizing bioassays using cell based assay, ELISA, HTRF, Enzyme activity, Enzyme Kinetics, Octet is required. Proficient in aseptic technique, mammalian and primary cell handling Proficient in data analysis with Excel and statistical tools such as GraphPad Prism, SoftMax Pro, and PLA 3.0 . Familiar with electronic notebooks and documentation workflows. Ability to balance competing priorities and thrive in a dynamic, fast-paced environment Excellent laboratory, critical thinking, scientific problem-solving, and organizational skills Excellent oral and written communication skills Motivated, detail-oriented, naturally curious individual with a creative approach to scientific problem solving and a burning desire to help patients with neurodegenerative diseases. Salary Range: $107,000.00 to $131,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Associate Director, Principal Scientist, Toxicology will play a critical role in driving the nonclinical safety assessment of small and large molecule therapeutics within Denali's pipeline. This position involves conducting and managing toxicology studies, analyzing and interpreting safety data, and collaborating with cross-functional teams to advance drug candidates through various stages of development. This role serves as a functional leader for the Toxicology team and includes people leadership accountability for one or more Toxicologists. Key Accountabilities/Core Job Responsibilities: Nonclinical Toxicology Support: Design and implement nonclinical toxicology programs and strategies to evaluate the safety of Denali's therapeutic candidates. Conduct and oversee non-GLP and GLP toxicology studies, ensuring adherence to regulatory standards. Data Analysis and Reporting: Analyze, interpret, and summarize toxicology data to support safety evaluations. Prepare and present safety data to internal project teams and senior management, contributing to informed decision-making. Regulatory Support: Assist in the preparation and authoring of regulatory documents related to nonclinical safety assessments. Ensure compliance with relevant regulatory guidelines and standards throughout all stages of toxicology studies. Collaboration and Cross-Functional Work: Work closely with colleagues in Research and Development, providing toxicology expertise to support cross-functional project teams. Participate in project meetings, offering insights and recommendations to advance safety assessment strategies. Investigative Efforts: Support investigative efforts into mechanisms of toxicity and contribute to the development of safer therapeutic candidates. Assist in developing and implementing de-risking strategies for drug discovery and development projects. People Leadership: Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement. Qualifications/Skills: PhD OR Advanced Degree in Toxicology, Biology, Pharmacology or related scientific discipline. At or near 7 plus years of relevant work experience inclusive of postdoctoral work; OR MS with 10+ years of relevant work experience. Experience with biologics and oligonucleotides preferred Strong scientific background and scientific aptitude Excellent critical thinking and scientific skills Ability to work effectively and collaboratively on cross-functional projects teams, and demonstrated can-do attitude Ability to work in a fast-paced environment Excellent oral, presentation, and written communication skills Salary Range: $203,000.00 to $240,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Senior Scientist in Clinical Pharmacology will develop clinical pharmacology and modeling and simulation (M&S) strategies for biotherapeutic and small molecule programs, guide project teams from early development through late-stage clinical trials and regulatory submissions. This role involves designing and executing clinical studies, analyzing pharmacokinetic (PK)/pharmacodynamic (PD) data, and collaborating with cross-functional teams to advance therapies for neurodegenerative diseases. This role is within the Quantitative and Clinical Pharmacology (QCP) team within the Development Sciences function. Key Accountabilities/Core Job Responsibilities: * Develop Clinical Pharmacology and M&S strategies for multiple biotherapeutics and small molecule programs from pre-IND through late-stage clinical studies, including pivotal Phase 2/3 trials and NDA/MAA/BLA submissions. * Develop clinical study designs and write study protocols, amendments, and reports that meet regulatory standards and project timelines with minimal supervision. * Conduct hands-on pharmacokinetic (PK) and pharmacodynamic (PD) data analysis using advanced tools and methodologies to support clinical decision-making. * Analyze, interpret, and communicate PK/PD data to project teams, senior leadership, and regulatory authorities. * Author and review sections of regulatory submissions, including IND/CTA and NDA/MAA/BLA filings. Qualifications/Skills: * PhD or PharmD in Pharmaceutical Sciences, Pharmacokinetics, Pharmacology, or related scientific discipline with 5+ years experience in Clinical Pharmacology and drug development; may include relevant postdoctoral experience. * Proficiency in quantitative PK/PD data analysis tools (e.g., Phoenix WinNonlin, population PK analysis, exposure-response analysis, and/or PBPK modeling). * Experience in developing Clinical Pharmacology and M&S strategies, with biotherapeutics experience preferred. * Strong analytical and communication skills for presenting complex PK/PD data. * Proven ability to collaborate effectively on cross-functional teams. * Background in neuroscience indications and/or oligonucleotide drug development preferred. Salary Range: $142,000.00 to $198,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases. Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely. Summary: Responsible for leading in the development, implementation and maintenance of QA systems and activities supporting quality oversight towards GCP, GLP, and PV operations. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols. The incumbent is also responsible for developing specific internal procedures, training of staff, and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with Company's functional areas. The candidate will perform audits of service providers, study sites, and internal processes. The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP, PV, and GLP focused team settings and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of Company's clinical stakeholders and act as a catalyst for continuous process improvement. Responsibilities: Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws. Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements. Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline. Plan and oversee activities in support of regulatory submissions and inspections; Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI). Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines. Quality Management System (QMS): Maintain and enhance Caribou's QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle. Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders. Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical development and operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation. Build training and approve curricula based on the key elements of the Quality System; Provide leadership and oversight for training programs related to pre-clinical, clinical and PV. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures. Establish and monitor quality metrics and key performance indicators for the effectiveness of pre-clinical, clinical, and PV quality assurance activities. Prepare routine reports and presentations for senior/executive management review highlighting quality performance, trends, and areas for improvement. Assist with tracking compliance audit trends and present to management. Collaborate with cross-functional teams, including pre-clinical, clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of quality assurance activities. Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and service providers. Perform internal and external audits to ensure stakeholder system compliance with existing policies and procedures, and requirements, standards, and guidelines. Lead and/or manage additional Quality Assurance (GxP) initiatives or programs as business needs evolve. Qualifications: Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline with at least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry. Experience working in biologics is strongly preferred. Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research. Proven track record in developing and implementing quality systems and processes in a clinical setting. Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits. Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards. Prior GLP experience with quality oversight and auditing studies/vendors (preferred). Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for quality and regulatory compliance. The position requires a highly diplomatic, and tactful individual with excellent critical reasoning skills. Conscientiously detail-oriented and organized, impeccable attention to data review. Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways. Must be flexible and able to multi-task, prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks. Detail-oriented mindset with a proactive approach to problem-solving and decision-making. Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable. Ability to travel up to 25-30% based on business needs. Caribou compensation and benefits include: Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees Salary Range: $220,000 to $235,000- This represents the present low and high end of the Company's pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance. Generous paid vacation time, in addition to company-observed holidays Excellent medical, dental, and vision insurance 401(k) retirement savings plan, which includes matching employer contributions Employee stock purchase plan (ESPP) Tuition reimbursement program The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws. Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. Lead supply chain strategy for Denali's clinical products, including demand and supply planning, IRT strategy, and production management. Act as the primary supply chain contact, support Direct-to-Patient strategy, collaborate cross-functionally, troubleshoot issues, and communicate program status to stakeholders. Key Accountabilities/Core Job Responsibilities: Act as Supply Chain Lead for Denali's clinical products including developing the supply chain strategy, demand and supply planning, and IRT strategy development Execute scenario plans and develop recommended production and inventory management strategies Serve as primary supply chain contact with internal and external stakeholders Support Direct-to-Patient supply chain strategy development and execution Work cross-functionally with CMC, Development, and Finance departments to support program development Proactively identify and troubleshoot issues to prevent missed timelines Communicate program status both verbally and through written documents and reports Drive continuous operational performance improvement efforts Lead supply chain business process development projects Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement. (if applicable) Qualifications/Skills: ● Bachelor's degree in Industrial Engineering/Operations/Supply Chain or related field; MBA strongly preferred ● 5+ years experience in clinical supply chain planning in the Life Sciences. ● Experience leading business process definition/improvement is strongly preferred ● Skilled in using influence management to drive project success ● Demonstrated ability to work accurately, meet timelines and handle multiple priorities ● Capable of responding flexibly to changing prioritization in a dynamic environment ● Strong interpersonal skills and ability to work with others in a positive “can do” and collaborative manner ● Strong verbal and written communication skills ● Advanced analytical capabilities with proficiency in Excel, Word, and PowerPoint ● Requires working knowledge of cGMP and regulations applicable to the FDA and comparable international regulatory agencies Salary Range: $152,000.00 to $185,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This position will carry out oligonucleotide analytical development to support our Oligonucleotide Transport Vehicle (OTV) platform. This is an exciting and unique opportunity to contribute to several programs and position us for the future as our groundbreaking OTV therapeutics enter the clinical phase. Key Accountabilities/ Core Job Responsibilities: Design, execute, and interpret stability-indicating chromatographic methods for ASOs/si RNA. Develop and apply complementary characterization techniques for ASOs/si RNA, including UV-Vis spectroscopy, mass spectrometry, NMR, Karl Fischer titration, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and circular dichroism (CD). Analyze and interpret results, leveraging knowledge of oligonucleotide synthesis and purification processes to understand impurity profiles. Transfer analytical methods and manage activities at partner CDMOs, as needed (travel may be required). Author and/or review analytical data, specifications, Certificates of Analysis, and method validation protocols and reports. Collaborate with discovery scientists, process chemists, quality, and project teams to advance our portfolio and analytical strategies and ensure timely flow of information. Experience with modern artificial intelligence or machine-learning approaches to support chemistry workflows is a plus. Perform other responsibilities as needed. Qualifications/Skills: M.Sc./B.Sc. with 5+ years of relevant experience, with a record of scientific leadership and innovation as demonstrated by publications and/or patents Deep understanding of and demonstrated excellence in the analysis of oligonucleotides and their starting materials. Expertise in mass spectrometry is expected Knowledge of phase-appropriate QC/analytics relevant to oligonucleotide analysis Strong written and verbal communication skills Salary Range: $125,000.00 to $158,333.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Fate Therapeutics is seeking a motivated and execution-driven Manager/Senior Manager to support GMP manufacturing operations of iPSC-derived allogenic cell therapy products. As an integral part of the Manufacturing Team, this role is responsible for overseeing operational execution in addition to managing manufacturing quality events including deviations, CAPAs, and other required change actions. This individual will play a pivotal role in defining and executing the company's operational strategy to enable the execution of a sustainable, scalable and GMP compliant manufacturing process. Accordingly, this role will require proven leadership abilities to drive meaningful communication, collaboration and coordination both internally within the Manufacturing department as well as cross-functionally across all levels of the organization. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA. Responsibilities * Responsible for overseeing end-to-end GMP production of iPSC-based drug product from media preparation and thaw of MCB's through harvest and cryopreservation of drug product. * Work effectively with other groups including Quality Assurance, Supply Chain, Quality Control, MSAT, Process Development, and Facilities. * Coordinate with applicable departments to manage Deviations, CAPAs, Continuous Improvements, Impact Assessments and Change Actions. * Assure manufacturing facility is maintained in an inspection-ready state at all times. * Engage with Materials Management and Planning and Sourcing teams to assure adequate inventory of raw materials to support planned production activities. * Project management utilizing tools including but not limited to SmartSheet and Microsoft Office tools. * Assure manufacturing staff meet and maintain cGMP training requirements. * Develop personnel schedules to allow effective execution of manufacturing activities. * Review and approve applicable manufacturing-related documentation. * Lead authorship and review process of SOPs and GMP BRs. * Identify potential process improvements for Manufacturing and design appropriate experiments to evaluate and implement those changes. * May hire, oversee, train, and motivate team members, ensuring that team goals are met efficiently. Qualifications * Bachelor's or Master's degree in a relevant discipline with 6+ years of Life Science GMP Manufacturing experience is required. * A strong manufacturing administration background specifically related to tech transfer of aseptically produced cell products is preferred. * A strong emphasis on quality event management and process improvement for manufacturing operations * Ability to create, read, review, and edit manufacturing related documents including Batch Records, SOP's, Work Instructions and associated forms. * Self-motivated, flexible, able to prioritize, multi-task, and work in a fast-paced & dynamic environment. * Experience leading projects and managing teams is required. Working Conditions * Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. * Will require working with cells and cell lines of human and/or animal origin. * Will require working with hazardous materials. * Will require work in controlled and cGMP Manufacturing environments requiring special gowning. Compensation * The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location. * Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package. * The anticipated salary range for this role is $110,000 - $150,000. The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time. Equal Employment Opportunity Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. Privacy Notice To learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company's pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit ************************* ️ Recruitment Fraud Alert Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker's personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams. Here are a few things to be aware of to help identify recruitment fraud: * Our Talent Acquisition team only corresponds from ************************* domain. * At no stage in our hiring process will we require payment or ask you to make deposits in your bank account. * We will only ask for personal information when applying for a position via our Careers page or thereafter. * At no stage during our hiring process will we ask you to click a link to begin a one-way video interview. * We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews. Please exercise caution. If something feels off about your interactions, we encourage you to contact us at [email protected] to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. We are seeking a talented and experienced scientist to develop, optimize, and establish state-of-the-art potency assays for our diverse pipeline of large molecule biotherapeutics. The ideal candidate should have hands-on experience in ligand-based and cell-based bioassays to characterize activity and potency of a variety of modalities including antibodies and Fc-fusion proteins as well as potentially oligonucleotide-conjugates and virus-based gene therapies. The candidate will join a broader process development group with opportunities to closely collaborate on all aspects of analytical, formulation, and process development. Key Accountabilities/Core Job Responsibilities: * Lead the design, development, and optimization of cell-based and biochemical bioassays to evaluate the potency and activity of therapeutic products * Developing, optimizing, and qualifying bioassays for product release and stability testing as well as supporting bioprocess and formulation development, and product characterization activities. * Serve as subject matter expert (SME) for potency assays, promoting innovation and exploring novel approaches for developing and troubleshooting complex assays. * Maintaining complete and accurate records and contribute to continuing process improvement. * Representing the Bioassay team cross-functionally and continuously drive Bioassay method development through internal and external collaborations. * Presenting experimental results in team meetings. * Detailed recording and analysis of experiments in an electronic laboratory notebook (ELN) * Coordinating parallel tasks across multiple projects and prioritizing deliverables to meet departmental and organizational goals. Qualifications/Skills: * B.S./M.S. in relevant scientific discipline with a minimum of 5 years of direct CMC bioassay development experience in biotech/biopharma or Ph.D. with 1+ years of directly relevant experience * Direct experience developing and optimizing binding and functional cell-based bioassays using platforms such as ELISA, HTRF, DELFIA, or qPCR to measure target engagement, cellular uptake, and transcript-level modulation. * Demonstrated expertise in phase-appropriate assay transfer, qualification, and validation within a CMC and GMP-regulated environment. * Strong understanding of regulatory expectations for bioassay development and validation (e.g., ICH Q2(R2), USP). * Demonstrated ability to independently design experiments and resolve technical challenges. * Innovative mindset, with experience introducing new technologies and process improvements in bioassay development. * Proficient with electronic lab notebooks and analytical or statistical software (GraphPad Prism, SoftMax Pro, PLA 3.0, JMP) is essential. * Adept at managing competing priorities and thriving in a fast-paced, dynamic environment. * Excellent laboratory, analytical, and organizational skills, with strong critical thinking and problem-solving ability. * Exceptional oral and written communication skills. * Motivated, detail-oriented, and intellectually curious scientist with a creative approach to problem solving and a deep commitment to improving the lives of patients with neurodegenerative diseases. Salary Range: $125,000.00 to $158,333.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Associate Director, Principal Scientist, Toxicology will play a critical role in driving the nonclinical safety assessment of small and large molecule therapeutics within Denali's pipeline. This position involves conducting and managing toxicology studies, analyzing and interpreting safety data, and collaborating with cross-functional teams to advance drug candidates through various stages of development. This role serves as a functional leader for the Toxicology team and includes people leadership accountability for one or more Toxicologists. Key Accountabilities/Core Job Responsibilities: Nonclinical Toxicology Support: * Design and implement nonclinical toxicology programs and strategies to evaluate the safety of Denali's therapeutic candidates. * Conduct and oversee non-GLP and GLP toxicology studies, ensuring adherence to regulatory standards. Data Analysis and Reporting: * Analyze, interpret, and summarize toxicology data to support safety evaluations. * Prepare and present safety data to internal project teams and senior management, contributing to informed decision-making. Regulatory Support: * Assist in the preparation and authoring of regulatory documents related to nonclinical safety assessments. * Ensure compliance with relevant regulatory guidelines and standards throughout all stages of toxicology studies. Collaboration and Cross-Functional Work: * Work closely with colleagues in Research and Development, providing toxicology expertise to support cross-functional project teams. * Participate in project meetings, offering insights and recommendations to advance safety assessment strategies. Investigative Efforts: * Support investigative efforts into mechanisms of toxicity and contribute to the development of safer therapeutic candidates. * Assist in developing and implementing de-risking strategies for drug discovery and development projects. People Leadership: * Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement. Qualifications/Skills: * PhD OR Advanced Degree in Toxicology, Biology, Pharmacology or related scientific discipline. * At or near 7 plus years of relevant work experience inclusive of postdoctoral work; OR MS with 10+ years of relevant work experience. * Experience with biologics and oligonucleotides preferred * Strong scientific background and scientific aptitude * Excellent critical thinking and scientific skills * Ability to work effectively and collaboratively on cross-functional projects teams, and demonstrated can-do attitude * Ability to work in a fast-paced environment * Excellent oral, presentation, and written communication skills Salary Range: $203,000.00 to $240,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. We are seeking to hire an Associate Scientist to join our Purification Process Development team. The successful candidate will be responsible for supporting late-stage downstream process development activities for our large molecule pipeline. Key Accountabilities/Core Job Responsibilities: Support purification process characterization, validation, PPQ and BLA-enabling activities. Monitor process performance, trend data, and coordinate sample handling from GMP manufacturing campaigns. Extract and organize data for report and submission authoring and contribute to statistical analysis. Support tech transfer for and GMP campaign readiness. Execute lab-scale chromatography and filtration studies to inform late-stage data packages. Execute in-process testing using ELISA, HPLC, UV and SDS-Page based analytics Summarize key experimental data and document all experiments in an electronic lab notebook in a timely manner. Collaborate closely with colleagues in CMC, Discovery and other functions to achieve project goals. Requirements BS/MS in Biology, Biochemistry, Chemical Engineering or related scientific discipline with 3+ years of industry experience Experience in protein characterization, design of experiments and analytics Experience monitoring downstream GMP and/or pilot production unit operations Hands-on experience with AKTA protein purification systems, lab-scale TFF systems and antibody characterization methods including: HPLC, LC/MS, SDS‐PAGE, DLS and other biophysical techniques Excellent critical thinking, scientific problem-solving and communication skills Prior experience in a late-stage process development setting is preferred Salary Range: $107,000.00 to $131,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. This position will carry out oligonucleotide analytical development to support our Oligonucleotide Transport Vehicle (OTV) platform. This is an exciting and unique opportunity to contribute to several programs and position us for the future as our groundbreaking OTV therapeutics enter the clinical phase. Key Accountabilities/ Core Job Responsibilities: * Design, execute, and interpret stability-indicating chromatographic methods for ASOs/si RNA. * Develop and apply complementary characterization techniques for ASOs/si RNA, including UV-Vis spectroscopy, mass spectrometry, NMR, Karl Fischer titration, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and circular dichroism (CD). * Analyze and interpret results, leveraging knowledge of oligonucleotide synthesis and purification processes to understand impurity profiles. * Transfer analytical methods and manage activities at partner CDMOs, as needed (travel may be required). * Author and/or review analytical data, specifications, Certificates of Analysis, and method validation protocols and reports. * Collaborate with discovery scientists, process chemists, quality, and project teams to advance our portfolio and analytical strategies and ensure timely flow of information. * Experience with modern artificial intelligence or machine-learning approaches to support chemistry workflows is a plus. * Perform other responsibilities as needed. Qualifications/Skills: * M.Sc./B.Sc. with 5+ years of relevant experience, with a record of scientific leadership and innovation as demonstrated by publications and/or patents * Deep understanding of and demonstrated excellence in the analysis of oligonucleotides and their starting materials. * Expertise in mass spectrometry is expected * Knowledge of phase-appropriate QC/analytics relevant to oligonucleotide analysis * Strong written and verbal communication skills Salary Range: $125,000.00 to $158,333.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at ****************************************** This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future. Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be 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 and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.