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.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES/PURPOSE - Oversee and provide quality patient engagement and recruitment services that allow study teams to meet patient enrollment goals. - Work to deploy new processes, methodologies, data and technologies for future implementation ACCOUNTABILITIES - Oversee execution of patient recruitment deliverables regarding operational planning activities supporting clinical project teams building phase 2 through phase 4 clinical research studies including: Early operational planning, Protocol synopsis feasibility assessments, Enrollment forecasting and modeling, building Recruitment support strategies (e.g. central recruitment), Recruitment and retention plans - Ensure delivery of high-quality subject recruitment and retention plans in collaboration with the Takeda clinical project teams/study team and contracted supplier(s) before First Patient First Visit. - Manage quantitative decision support framework for strategy development, vendor selection, and objective setting. - Manage contract and vendor relationship framework to align with adherence to RVRM and quantitative decision support framework. - Systematically evaluate and communicate financial impact of specialist vendor (recruitment and retention) and recruitment strategies to important partners. - Build daily delivery of activities as described above supporting clinical programs (e.g. including delivery of decision support data and methodologies for protocol development, site selection and management of recruitment support vendors. - Support Director with activities related to: process improvement and mapping, training, inter-departmental collaboration (e.g. compliance, DSI technologies) EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS - Bachelor's Degree. - 5 or more years of experience in patient recruitment with evidence of increasing responsibility within a pharmaceutical company, CRO or similar organization. - Expertise in developing recruitment and retention strategies, country/site identification, and generation of material and trial metrics. - Successful leadership, and development of large, diverse globally dispersed teams experience. - Knowledge of leading-edge trial optimization vendors, tools, and methods. - Knowledge of current regulatory requirements and guidelines governing clinical research. - Experience in process design and improvement. - Understanding of clinical trials, relevant knowledge of GCP/ICH and applicable global regulations with regard to trial optimization strategies. This position is currently classified as “remote” by Takeda’s Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $153,600.00 - $241,340.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Sr CRA - Oncology- Southeast US ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. What You Will Be Doing: - Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards. - Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution. - Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting. - Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct. - Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations. Your Profile: - Advanced degree in a relevant field such as life sciences, nursing, or medicine. - Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements. - Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills. - Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools. - Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment. - Must be located on the Southeast states - Experience monitoring oncology trials is required - Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Purpose: The Clinical Research Lead (CRL) is a strategic, field-based scientific leader responsible for driving the execution of Lilly clinical trials through exceptional investigator engagement and site performance management. This role is pivotal in ensuring Lilly’s portfolio is prioritized at high-performing sites and that trials are delivered with quality, speed, and insight. CRLs combine deep therapeutic and scientific knowledge with strategic agility to influence investigators, elevate protocol understanding, and co-develop tailored enrollment strategies in existing and new therapeutic areas. They serve as trusted partners to investigators—building strong, enduring relationships that improve return on enrollment and position Lilly as the sponsor of choice. CRLs partner closely with internal Lilly teams (including Clinical Development and Medical Affairs) to ensure that insights from the field shape development strategies and that development strategies are delivered with operational excellence and scientific clarity. Where applicable the CRL may also represent Investigator Engagement with Regulatory and External Bodies and help shape the country-level clinical trial landscape. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Clinical Investigator Management - Accountable for the full spectrum of investigator engagement from identification and qualification through enrollment, and support database lock, and study closeout - Serve as a clinical trial scientific ambassador, ensuring investigators deeply understand protocol intent, scientific rationale, and patient eligibility requirements - Develop and sustain strategic, high-trust relationships with investigators that span trials and therapeutic areas - Influence enrollment by co-creating tailored recruitment strategies aligned with site capabilities, patient population realities, and study objectives - Proactively find opportunities to reach new patients, accelerate enrollment and increase impact at priority sites, including for example, novel site models, community-based research initiatives etc - Capture and elevate critical insights from sites to optimize feasibility, protocol design, and study conduct Clinical Trial Management - Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data delivery - Leverage performance metrics to anticipate issues, intervene decisively, and maintain momentum toward clinical milestones - Drive inspection readiness as a continuous discipline across sites - Collaborate across functions and with vendor partners to resolve operational barriers, ensuring delivery with speed and quality - Maintain advanced understanding of local treatment paradigms and standard of care to influence strategic country/site selection and protocol localization - Provide oversight and quality assurance for vendor monitoring, escalating risks proactively - Where applicable, lead end-to-end management of Post-Marketing Safety Studies in compliance with local regulations Business Management and Engagement - Cultivate a portfolio of strategically aligned, high-impact investigators who consistently prioritize Lilly trials - Enable an exceptional investigator experience by being a responsive, knowledgeable, and valued scientific partner - Collaborate cross-functionally (e.g., Medical, Clinical, Study Delivery) to align on trial and site priorities, troubleshooting challenges with urgency and creativity - Conduct data-informed site prospecting and prioritization, contributing to trial competitiveness and regional strategic execution - Maintain scientific fluency and therapeutic expertise to lead meaningful, solutions-focused discussions with site personnel - Act as a key liaison between field teams, vendors, and investigators, ensuring alignment, shared purpose, and continuous knowledge transfer - Partner closely with field team colleagues to elevate the investigator and site experience, ensuring seamless collaboration and improving enrollment outcomes and Investigator relationships Country / Regulatory Engagement (where applicable) - Represent Investigator Engagement with regulatory agencies, ethics committees, and national research organizations in countries/territory - Influence the clinical trial ecosystem to improve regulatory agility and operational feasibility - Ensure that local requirements are translated into compliant, efficient trial execution and that Lilly’s internal processes reflect evolving country landscapes - Partner with leadership to identify and align regional initiatives and contribute to enterprise-wide clinical development success Minimum Qualification Requirements: - Bachelor’s degree or equivalent; strong preference for scientific, clinical, or health-related fields - Minimum 5 years of experience in clinical research or pharmaceutical industry with experience directly interacting with or working with HCPs and clinical sites - Minimum 2 years of relevant clinical or deep therapeutic area experience in Oncology - Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position - Currently reside in or be willing to relocate to our designated region Other Information/Additional Preferences: - Advanced degree in a scientific or clinical field (PharmD, PhD, MD, or MSc preferred) - Excellent understanding of GCP, clinical development and operations, and trial lifecycle - Demonstrated understanding of the therapeutic landscape and standards of care, with the ability to apply this knowledge to decision making - Proven ability to build credibility and influence HCP community through scientific acumen and relationship strength - Strategic approach with demonstrated success in delivering results in complex, fast-paced environments - Data-driven decision-making skills; ability to interpret and act on performance and operational metrics - Excellent communication, negotiation, and organizational skills - Deep therapeutic area knowledge and familiarity with local clinical research ecosystems - Experience directly influencing clinical site performance and driving enrollment success - Track record of delivering or exceeding performance targets in a collaborative matrix environment - Experience working with regulators or national bodies in support of clinical trial delivery - English fluency and proficiency in local language(s) as needed Travel Requirements: - Willingness to travel extensively (60-80%) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly