Allogene Therapeutics

Role Description As the Specialist, Clinical Supply Chain, you will support clinical supply chain activities with a primary focus on clinical shipments, shipment execution, and study-level logistics coordination. This role will serve as a key point of contact for Clinical Operations and Allogene’s third-party logistics providers for shipment-related questions and issue resolution, ensuring timely, compliant, and efficient movement of clinical materials from order intake through confirmed delivery to clinical sites. The role will partner closely with Clinical Operations, Transportation & Logistics, Quality Assurance, external depots, couriers, and 3PL providers to coordinate end-to-end shipment activities for Allogene’s ongoing clinical trials. Responsibilities include managing shipment request intake, monitoring shipments across each leg of transport, maintaining shipment metrics and order processes, supporting packaging plan development, and driving continuous improvement initiatives related to finished goods distribution, documentation, and ERP-enabled processes. - Serve as the primary Clinical Supply Chain point of contact for Clinical Operations and Allogene’s 3PL providers for shipment-related questions, issue escalation, and delivery coordination - Manage end-to-end clinical shipment activities from order intake through scheduling, execution, tracking, and confirmation of successful delivery to clinical sites - Coordinate deliveries from depots to clinical sites to ensure on-time and in-full delivery of clinical materials - Monitor critical shipments across each leg of transport and proactively resolve shipment-related issues with couriers, customs brokers, depots, and internal stakeholders - Ensure all required shipment documentation, forms, and study-specific records are complete, accurate, available to the appropriate parties, and filed appropriately - Support development and maintenance of Clinical Supply Chain metrics to improve visibility and performance - Support packaging plan development and packaging execution for finished goods including transactional steps, and ERP-related activities associated with material release and readiness - Partner with Clinical Operations and Transportation & Logistics to maintain effective shipment communication processes for Allogene’s ongoing studies - Support investigation and triage of shipment deviations, temperature excursions, delayed deliveries, and product complaints in partnership with Quality Assurance and other cross-functional teams - Identify and implement continuous improvement opportunities related to shipment execution, packaging workflows, documentation, and logistics processes - Perform other duties as assigned Qualifications - Bachelor’s Degree in Life Sciences, supply chain, business administration, or related field required; certification in logistics, planning, or APICS/CPIM preferred - 3+ years of relevant experience in clinical supply chain, logistics, distribution, or planning within the pharmaceutical or biotechnology industry - Cell & Gene Therapy experience is a plus - Experience coordinating domestic and international clinical shipments, including cold chain logistics and shipment tracking across multiple partners - Understanding of clinical supply chain operations, finished goods distribution, packaging and labeling workflows, and study-level shipment execution - Working knowledge of ERP systems such as SAP and familiarity with inventory, order, and shipment-related transactions and documentation - Experience working effectively with cross-functional teams in a fast-paced, dynamic environment, including Clinical Operations, Quality, Supply Planning, and external service providers - Strong organizational skills with the ability to manage multiple shipment requests, prioritize effectively, and deliver results within established timelines - Excellent interpersonal, verbal, and written communication skills, with the ability to coordinate effectively across internal stakeholders and external partners - Demonstrated continuous improvement mindset and interest in developing scalable processes, shipment metrics, and operational tools - Self-motivated and comfortable operating with a high degree of ownership in a fast-paced environment - Candidates must be authorized to work in the U.S. Benefits - Annual performance bonus - Equity - Health insurance - Generous time off (including 2 annual holiday company-wide shutdowns) - Much more

Role Description We are seeking a highly motivated individual in this exciting new area of cancer immunotherapy. In this role you will be responsible for the important elements of the Supplier Qualification Management (SQM) program, specifically quality agreement negotiation and management. This is a contract position working 20-25 hours per week. - Responsible for supplier questionnaire management, including improving questionnaire content, coordination of questionnaire completion with suppliers, and evaluation of responses - Develop quality agreement templates and establish preferred, standard, and fallback terms - Conduct and/or facilitate quality agreement negotiations - Perform quality agreement periodic reviews - Assist in supplier qualification activities and supplier monitoring activities - Assist in departmental and cross-functional process improvement initiatives and special projects as identified by management to support the business need - Other duties as assigned Qualifications - Bachelor’s degree in Engineering, Chemistry or Biological Sciences required - Prior experience in quality assurance/SQM, manufacturing, QC or quality engineering - Experience in quality agreements negotiation and management required - Extensive working knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and have a proven track record of successfully implementing these requirements - Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment - Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities - Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines - Proficient in MS Word, Excel, Power Point - Experience with Veeva is a plus but not required - Candidates must be authorized to work in the US Benefits - Annual performance bonus - Equity - Health insurance - Generous time off (including 2 annual holiday company-wide shutdowns) - Much more

Title: Medical Director, Pharmacovigilance Location: Pharmacovigilance | Hybrid in South San Francisco, CA Full Time From $250,000 to $335,000 per year Job Description: About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. About the role: Reporting to the VP, Pharmacovigilance, the Medical Director, Pharmacovigilance serves as the safety expert accountable for the global safety strategy and overall safety profile throughout a product's lifecycle. This includes leading all major pre- and post-marketing safety deliverables including signal detection, benefit-risk evaluation and risk management activities. You will help develop and lead surveillance activities and provide scientific/clinical/pharmacovigilance expertise for safety data analysis from various sources including pre-clinical studies, clinical studies, literature and other information sources. You will focus on the proactive identification, evaluation, and risk management of safety risks to patients. Ideally this is a hybrid role based at our headquarters in South San Francisco, CA. Remote candidates will be evaluated based on suitability for the position along with ability to travel to HQ. Responsibilities include, but are not limited to: - Manage all pre- and post-marketing safety surveillance activities throughout lifecycle in compliance with ICH guidelines, FDA / EMA / applicable global health authority regulations related to Good Pharmacovigilance Practices (GVP) - Lead and provide input to global safety strategy ensuring review and assessment of pre-clinical, clinical, and post-marketing safety data to ensure positive benefit-risk profile for Allogenic CAR T therapy in collaboration with essential stakeholders - Collaborate with other functional areas, including but not limited to Biostatistics, Clinical, Translational Sciences, Research and Regulatory Affairs to identify, evaluate, understand and develop risk management strategies for safety signals - Provide clinical safety support and input for clinical development programs - Participate in the authoring of relevant safety sections of clinical protocols, Investigator's Brochure (IB), informed consent form (ICF), statistical analysis plans, study reports and other clinical study-related documents to ensure alignment with the safety strategy and risk communication - Participate in the development of safety-related data collection standards for clinical studies to ensure consistency in safety data collection - Collaborate on the strategy and authoring of health authority and other safety related query responses - Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reports - Medical review of individual case safety reports (ICSRs) in a timely manner to ensure on time submission to regulatory authorities - Demonstrate knowledge and ensure compliance with current and applicable global PV regulations (e.g., CIOMS, EMA, FDA, ICH) - Other duties as assigned Position Requirements & Experience: - Medical degree (MD) with a strong clinical background, with at least 3 of relevant years industry experience - Experience in clinical practice or clinical research is preferred - Experience in oncology and/or cell therapy is strongly preferred - Thorough understanding of pharmacovigilance principles, global regulatory requirements, and MedDRA coding - Experience in signal detection, evaluation, aggregate data analysis, and interpretation in clinical trials - Must be proficient in Argus - Excellent analytical and critical thinking skills to evaluate complex medical data - Strong communication and collaboration skills to effectively interact with cross-functional teams - Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team - Ability to communicate with internal and external physicians to evaluate specific safety events - Candidates must be authorized to work in the U.S We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $255,000 to $335,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law. As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought, designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

Title: Director, Global Medical Information & Scientific Communications Location: Remote in South San Francisco, CA | Full Time | From $200,000 to $250,000 per year Job Description About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. About the role: Allogene Therapeutics is seeking an experienced Director, Global Medical Information & Scientific Communications to lead the execution of a comprehensive medical information and scientific communications strategy across pipeline assets. This role will be accountable for defining and executing the global medical information and scientific communications strategy, establishing operational excellence, and ensuring compliant, high-impact scientific exchange aligned with Allogene’s mission to advance allogeneic CAR-T therapies for patients with serious diseases. In addition, this role will provide site-support for selected global trial sites supporting the ALPHA3 study, partnering closely with Clinical Development, Clinical Operations, and Field Medical leadership (E.g., SIV attendance, PI relationship-building, 1:1 investigator meeting facilitation). The position is remote based in the U.S. and reports into Medical Affairs leadership. The ideal candidate is interested in working in a fast-paced, dynamic, and highly collaborative biotech environment with a willingness and ability to successfully take on new challenges. We encourage applicants who believe they have the skills and drive to succeed at Allogene to apply for this role. Responsibilities include, but are not limited to: - Lead Medical Information (MI) support for assigned pipeline assets, including development of processes and SOPs for intake/triage of unsolicited inquiries, development of scientifically balanced responses, and documentation of inquiry handling. Maintain the Medical Information (MI) content library (e.g., SRLs, FAQs, and non-standard response letters) across pipeline assets. - Drive Medical Communications (MC) for assigned pipeline assets in partnership with internal stakeholders and external vendors/agencies, including development of the scientific platform and creation/review of scientific communication deliverables (e.g., slide decks, congress materials, FAQs, field medical materials) through MRC review and warehousing. - Lead publications planning and execution for assigned pipeline assets in alignment with Good Publication Practice (GPP) and authorship standards (e.g., ICMJE), including publication plan development, review committee coordination, and support of abstracts, posters/orals, and manuscripts with external authors. - Engage and maintain relationships with external scientific stakeholders (e.g., investigators, KOLs, and societies) to support publication and trial site support activities as needed. - Ensure all activities adhere to applicable regulations and company policies, including appropriate use of approved materials, documentation standards, and medical/legal/regulatory review requirements. - Maintain scientific expertise in relevant disease areas with the ability to translate complex data into clear, audience-appropriate scientific content. - Execute Field Medical-aligned activities for assigned ALPHA3 global study sites in, (e.g., site education and/or scientific discussions as requested). - Other duties as assigned. Position Requirements & Experience: - Advanced degree in life sciences field (APN, PhD, PharmD, MD) - 4-6+ years of experience in Medical Affairs (Medical Information, Medical Communications, Publications, or a combination), within the pharmaceutical/biotech industry; experience supporting pipeline/launch readiness preferred. - Working understanding of medical affairs principles, the end-to-end lifecycle of scientific content (e.g., MI response documents, medical communications materials, and publications), building HCP relationships, and engaging in scientific exchange. - Willingness to travel (up to ~40% of time, including overnight travel) to support global ALPHA3 sites and attend internal meetings and scientific congresses, as needed. - Excellent communication, presentation, and time management skills required; must be adaptable and able to work well within a team and relate effectively with people at all levels of the organization - Familiarity with applicable legal, regulatory, and compliance requirements for scientific exchange and clinical trial site interactions; ability to operate compliantly across multiple geographies. - Ability to partner with key internal stakeholders to understand key objectives and to drive plans that achieve or exceed these - Ability to effectively work in a fast-paced, biotech environment, while dealing with ambiguity and ability to work independently and as part of a team - Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines and strong interpersonal skills including verbal and written communication are essential in this collaborative work environment - Candidates must be authorized to work in the U.S. and able to travel internationally for business (i.e., obtain/maintain a valid passport and any required visas/entry documentation, as needed). We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $200,000 to $250,000. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law. As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients. #LI-REMOTE #LI-TF1

Title: Director, External Quality Location: Quality | Hybrid in South San Francisco, CA | Full Time | From $200,000 to $230,000 per year Job Description: About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. About the role: Allogene is seeking a Director of External Quality to lead the Quality Assurance function for Contract Manufacturing Operations (CMO) Oversight and Supplier Quality Management (SQM). This position will require active engagement and strategic vision for the QA role in the company and will report to the Head of CMC Quality. The position will be responsible for providing direction and decision regard to quality oversight of starting material (SM), drug substance (DS) and drug product (DP) and labeling and packaging operations at the CMO. Additionally, this role will oversee the quality of material suppliers, including media, chemicals, excipients, single-use systems, and primary and secondary packaging components. The position is a hybrid role and requires 3 days a week at either Allogene headquarters in South San Francisco or Allogene's manufacturing facility in Newark, CA. Responsibilities include, but are not limited to: - Provide Quality functional leadership in the Quality team including hiring and managing, high performing quality assurance staff designed to meet the technical and compliance requirements - Provide QA support for the manufacturing and disposition of GMP starting materials, Drug Substance, Drug Product, and packaged and labeled products. Responsible for disposition of GMP products utilizing trained and qualified QA staff. - Collaborate with Manufacturing, Supply Chain and CMC Program Management to assure on time delivery of approved products. - Provide quality oversight of material suppliers and QA guidance for our CMO and supplier qualification - Work directly with operating entities (internal and CMOs) to ensure that products (i.e., SM, DS, DP, and packaged and labeled product) meet all required quality standards and specifications. - Influence other functional departments to ensure that CMOs achieve and maintain the appropriate levels of GMP compliance and provide quality services and work with CMOs to ensure their cGMP processes and procedures provide continuous evaluations and improvements to their quality systems. - Build strong interdependent relationship with CMO Project Management Counterparts, QA and QC teams in order to assess the as is state and risks for action-oriented improvement plans. - Provide QA guidance and support for supplier qualification, technology transfer, scale-up, validation and other GMP activities associated with products manufactured by CMOs. - Facilitate the resolution of quality issues with internal and external parties in a timely manner and coordinate communications with CMOs/suppliers and internal technical product teams for quality issues. - Execute QA programs and activities; this includes assisting with training and auditing programs, as well as the review of SOPs, investigations, specifications, methods, reports and manufacturing records. - Align and negotiate Quality Agreement terms with internal stakeholders and external partners - Represent the Quality function in product development (CMC) teams, engaging all quality stakeholders to ensure product deliverables are met through the product lifecycle. - Review and approve CMC sections of regulatory filings as needed. - Assist the Quality Management Systems function in the development, establishment and maintenance of internal Quality Systems processes and procedures (e.g., change control, training, audit, CMO and supplier management, deviation and CAPA) that complies with applicable GMP standards, regulations and guidelines. - Drives continuous improvement utilizing quality tools such as lean, six sigma, and risk management. - Contribute to the development and maintenance of a positive team culture - Role will entail operating in a fast-paced, highly dynamic environment with key company work partnerships including both internal and external stakeholders. Position Requirements & Experience: - Bachelor's degree in Engineering, Chemistry or biological sciences required; advanced degree preferred (education or training in cell culture and gene therapy a plus), ASQ Auditor certification, ASQ Quality Engineer certification preferred. - At least 12 years in a technical role in manufacturing, QA, QC and/or quality engineering with demonstrated manufacturing plant experience in the bio-pharmaceutical, pharmaceutical, or medical device with at least 5 years in a related management role. - Extensive working knowledge of quality system requirements such as US FDA GMP, EMA, and ICH guidelines and have a proven track record of successfully implementing these requirements. - Knowledge of fundamental quality engineering principles such as process capability, process control, and structured problem solving, including root cause investigations. - Proficient in MS Word, Excel, PowerPoint, Visio, Project, and statistical software. - Demonstrated ability to successfully interact with regulatory health authorities at inspections (prior experiencing leading inspections is required). - Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity. - Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously. - Excellent communication skills and demonstrated ability to work well with others will be essential. - Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines. - Ability to work independently and as part of a team, strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment. - Candidates must be authorized to work in the U.S - Travel up to 10% We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $200,000 to $230,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law. As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients. #LI-EL1 #LI-HYBRID

Role Description Allogene Therapeutics is seeking a highly motivated Executive Director, Market Access who will define and lead Allogene’s global market access strategy to support the successful launch and commercialization of its allogeneic CAR T therapies. This leader will be responsible for: - Pricing strategy - Payer engagement - Reimbursement - Patient support services - Distribution strategy This role will play a critical part in addressing: - Site-of-care dynamics - Center-of-excellence (COE) networks - Single case agreements - Innovative payment models As a key member of the Commercial organization, this role will partner closely with: - Corporate Affairs - Business Development - Medical Affairs - HEOR - Clinical Development - Regulatory Responsibilities include, but are not limited to: - Develop and execute a comprehensive market access strategy, including pricing, reimbursement, and payer engagement, to support launch and lifecycle management of allogeneic CAR T therapies. - Lead cross-functional development of payer value propositions, access strategies, and evidence plans aligned with clinical and commercial objectives. - Establish and maintain relationships with national and regional payers, including commercial insurers, Medicare Advantage, Medicaid, and employer groups, to secure favorable coverage and reimbursement. - Lead negotiation of coverage policies, reimbursement terms, single case agreements, and contract strategies specific to cell therapy delivery. - Design and implement access strategies that address CAR T–specific site-of-care requirements, including academic centers, community oncology practices, and evolving outpatient delivery models. - Monitor and influence payer and government policy, including CMS and state Medicaid developments, to address access barriers and support patient access. - Develop and implement innovative payment models and contracting approaches to support high-cost, one-time therapies. - Build and lead a field reimbursement organization to support providers navigating complex CAR T access pathways. - Design and implement patient support services to facilitate access, including benefits verification, reimbursement support, and care coordination. - Partner with Supply Chain and Commercial teams to develop distribution and channel strategies aligned with cell therapy logistics and treatment center capabilities. - Track payer coverage, reimbursement trends, COE network requirements, and competitive dynamics to inform strategy. - Provide strategic input into business development and financial planning related to pricing, access, and reimbursement. - Ensure all market access activities comply with relevant regulations and industry standards. - Other duties as assigned. Qualifications - Bachelor’s, Master’s or Pharm.D. degree in Life Sciences or related field (or relevant experience) - 15+ years of experience in market access, pricing, reimbursement, or related roles within biotech or pharmaceutical industry, including leadership experience - Demonstrated experience developing and executing market access strategy for oncology or specialty therapies, with direct experience in CAR T or cell therapy strongly preferred - Deep understanding of CAR T reimbursement dynamics, including single case agreements, site-of-care considerations, and COE network requirements - Experience working across both academic medical centers and community oncology settings - Strong understanding of innovative payment models and access considerations for high-cost, one-time therapies - Knowledge of oncology clinical data and health economics to support value-based discussions - Proven ability to lead cross-functional initiatives and influence senior stakeholders - Strong negotiation, communication, and analytical skills - Ability to operate effectively in a fast-paced, high-growth biotech environment - Strong financial management and business acumen - Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines - Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment - Candidates must be authorized to work in the U.S. Benefits - Annual performance bonus - Equity - Health insurance - Generous time off (including 2 annual holiday company-wide shutdowns) - Much more

Role Description Allogene Therapeutics is seeking a highly motivated Clinical Trial Management Associate to be responsible for the coordination of activities associated with clinical trial startup and maintenance under the direction of, or as delegated by a member of the Clinical Operations team. This is a 1-year contract opportunity with the possibility of extension or contract-to-hire. - Support all operational aspects of assigned clinical trial(s), including conduct of study start-up, Institutional Review Board (IRB) submissions, enrollment, study maintenance, and close-out. - Conduct study tracking activities (e.g., sites activation & participant enrollment status, reconciliation activities, filing & archiving). - Assist the Study Lead with the development, oversight, and/or completion of essential clinical documents including, but not limited to clinical study protocol, informed consent form, training slides and materials. - Contribute to region-specific document development including, but not limited to, the informed consent forms, regional investigator meetings/presentation of materials, the development of regional enrollment initiatives, and planning regional clinical study supplies. - Support the Study Lead in overseeing, managing, and tracking performance of assigned vendors selected for a clinical study which may include acting as a point of contact as delegated by the manager, facilitating review of vendor study specific documents, tracking performance indicators for vendors, creating and maintaining a vendor-specific issues log. - Participate in the review of monitoring/data reports, protocol deviations to ensure reliable quality data is delivered. - Assist with the oversight and maintenance of the study’s TMF. - Support Clinical Logistics with investigational supply communications and tracking. Qualifications - Minimum requirement of a BA/BS or equivalent degree. - Clinical research experience preferably in cell therapy and/or oncology. - Knowledge and understanding of ICH/GCP guidelines and FDA requirements for INDs and NDAs. - Flexibility and adaptability within a highly dynamic clinical environment. - Effective interpersonal and communication skills. - Ability to work independently as well as part of a team. - Outstanding organizational skills with the ability to multi-task and prioritize. - Ability to build and maintain successful professional relationships with vendors, other staff, and investigators. - Experience with TMF maintenance and management. - Ability to proactively identify potential study issues/risks and recommends/implements solutions. - Candidates must be authorized to work in the U.S. Benefits - Opportunity to work with talented people in a collaborative environment. - Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law. Company Description As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

Role Description The Clinical Trial Manager (CTM) is responsible for the management of clinical trials from study start-up activities through the clinical study report. The CTM drives completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required. - Manage all clinical aspects of study under oversight of Clinical Operations senior management including initial operational feasibility, study timelines, budget and metrics. - Study document development and review (training documentation, ICF, study specific plans, eCRF Guidelines, lab and radiology manuals, etc.). - Plans and manages study-specific meetings (e.g., Study Team Meetings, Investigator meetings, etc.). - Interface with cross-functional teams as Clinical Operations regional or global study lead (e.g., Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors and Investigators/site staff). - Work cross-functionally and with external vendors to proactively manage the execution of the clinical trial. - May oversee clinical trial execution in one or more regions within a global clinical trial. - Review protocol and amendment development, Informed Consent Forms, clinical trial-related training, and Site Study Tools. - Ensure clinical trial execution in compliance with the protocol and ICH/GCP guidelines/regulations, including the review of monitoring reports, protocol deviations, and eTMF. - Partner with Clinical Quality Assurance to follow through on corrective and preventative actions (CAPA) identified during internal and external audits. - Vendor oversight: effectively communicate expectations to CRO, ensure appropriate site management, hold CRO accountable to timelines, and verify quality metrics. - Provide study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel. - Manage study budget; review and approve clinical invoices against approved scope of work and budget, evaluate and approve vendor change orders, coordinating review of updates or revisions with key cross-functional partners, as necessary. - Prepare and present project debriefings to Clinical Operations management. - Provide study-related guidance and leadership to internal and external partners, as appropriate. Qualifications - Bachelor's degree or equivalent combination of education/experience in science or health-related field with clinical trial management experience in a Pharmaceutical/Biotech organization. - Clinical trial management work experience from an industry sponsor. - Prior clinical trial experience in oncology therapeutic development. - Vendor management experience. - Multi-regional study management experience is preferred. - Robust understanding of ICH/GCP, and knowledge of regulatory requirements. - Strong clinical study/project management skills. - Excellent communication and organizational skills (ability to prioritize a number of tasks of varying complexity), along with problem solving, conflict resolution, leadership and team-building skills. - Candidates must be authorized to work in the U.S. Benefits - Annual performance bonus. - Equity. - Health insurance. - Generous time off (including 2 annual holiday company-wide shutdowns). - Much more.

Role Description We are seeking a highly motivated individual to join us as a Patient Operations Management Associate in our Clinical Operations team. The Patient Operations Management Associate role is responsible for supporting the oversight and management of the Participant Pathway related to the scheduling, coordination and tracking of investigational product through the allogeneic enrollment process. This role will help oversee aspects of clinical logistics for one or more clinical trials at Allogene. The role must be able to work collaboratively with cross-functional teams to support study enrollment and corporate initiatives. - Manage patient scheduling tools, guidelines, work instructions, and dashboards for cell therapy product delivery. - Support tracking and reporting investigational product logistics information and patient metrics utilizing databases, spreadsheets, and other tools. - Support communication plans and templates for regular updates with Clinical Operations and sites on patient status. - Train to handling manuals and training materials for clinical sites regarding patient material shipping and product receipt to CRO staff, clinical site staff, and other audiences as needed. - Support IP logistics and supply chain processes for domestic and international clinical trial activities. - Support the management of vendors and systems associated with IP logistics with cross-functional stakeholder(s). - Participate in meetings to support the launch of clinical trials and ongoing enrollment activities. - Collaborate with key stakeholders to ensure a thorough patient journey program. - Recommend process improvements and promote a culture of collaboration and execution excellence. - Provides training to CRO staff, clinical site staff, and other audiences as needed. - Participate in the development, review and implementation of SOPs and processes, as needed. Qualifications - Bachelor’s degree or relevant experience. - Preferred experience in healthcare industry and FDA regulated environment. - Understands basic FDA & EMA regulations, ICH guidelines, GCP, and GMP. - Experience with clinical logistics and pharmaceutical supply chain systems. - Experience managing logistics activities for outsourced drugs such as warehousing, transportation, customs clearance and invoicing. - Familiar with domestic and international logistics/transport of biologic material: IATA, ICAO, ADR, DOT, WHO. - Excellent interpersonal and collaboration skills. - Able to work independently and collaboratively to accomplish primary objectives. - Demonstrates strong analytical skills to develop solutions to a variety of complex problems. - Organizational skills with the ability to multi-task and prioritize planning of activities. - Can support or lead vendor management efforts, as needed. - Self-starter, possessing a strong work ethic, ability to drive change, and passion for helping others. - Candidates must be authorized to work in the U.S. Benefits - Annual performance bonus. - Equity. - Health insurance. - Generous time off (including 2 annual holiday company-wide shutdowns). - Much more.

Role Description Allogene is seeking an experienced SAP Business Systems and Master Data Specialist to support Supply Chain, Manufacturing, Quality, and Warehouse operations, as well as related Master Data. Reporting to the Head of Supply Chain, this role is critical to supporting end users, ensuring SAP master data integrity, improving reporting, and driving continuous improvement initiatives. The role will be a part-time, contract position for a period of 6 months with possible extension. - Create and maintain SAP master data (Material Master, BOMs, Recipes, Production Versions, Business Partners, Inspection Plans) - Support day-to-day SAP operations, issue triage, troubleshooting, and root cause resolution for Supply Chain, Manufacturing, Quality, and Warehouse processes - Ensure data integrity through master data governance and formal change control - Develop and maintain SAP SOPs, work instructions, training materials, and documentation - Partner cross-functionally with Supply Chain, Manufacturing, Quality, Warehouse, and IT - Design and deliver SAP reports and analytics to support business decisions - Other duties as assigned. Qualifications - Bachelor’s degree in Supply Chain, Life Sciences, or related field (Master’s a plus) - 5+ years of SAP Master Data Management experience - 5+ years of SAP experience (S/4HANA strongly preferred) in Supply Chain, Manufacturing, Quality, and/or Warehouse operations - Strong knowledge of supply chain, manufacturing, quality and warehouse processes in a GMP environment - Experience in a regulated industry (biotech/pharma preferred) - Familiarity with FDA regulations (21 CFR 210/211) - Strong communication, organization, and cross‑functional collaboration skills - Candidates must reside in and be authorized to work in the U.S. Benefits We offer a chance to work with talented people in a collaborative environment. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law. Company Description As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.