Kailera

Associate Director, Clinical Data Management

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Senior Clinical Trial Manager

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The Associate Director, Clinical Data Management provides strategic oversight for outsourced clinical trials within Clinical Development Operations. This role involves developing and executing project plans, ensuring vendor quality and timelines, and serving as the primary data management representative on study teams. The Associate Director coordinates ongoing DM activities, collaborates with CROs and vendors for high-quality data delivery, and reports to the Head of Clinical Data Management. The position is hub-based in Waltham, MA, requiring 3-4 days onsite per week.

Director, Commercial Insights and Analytics

<p class="my-4 text-gray-700 leading-relaxed">At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.</p><p class="my-4 text-gray-700 leading-relaxed">We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.</p><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">What You’ll Do:</h2><p class="my-4 text-gray-700 leading-relaxed">The Associate Director, Clinical Data Management plays a key role within the Clinical Development Operations by providing strategic oversight of outsourced clinical trials. This position is responsible for developing and executing project plans for outsourced studies and ensuring vendor activities meet defined quality standards and timelines. As the primary data management representative on the study management team, the Associate Director coordinates ongoing DM activities, partnering closely with key stakeholders to implement a robust and transparent data strategy. They collaborate with CRO and vendor DM leads to drive timely, high-quality data delivery. This role reports to the Head of Clinical Data Management.</p><p class="my-4 text-gray-700 leading-relaxed"><em>Required location: Waltham, MA (hub-based, onsite 3-4 days per week).</em></p><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">Responsibilities:</h2><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Provide project-level leadership for clinical data management (CDM) activities, monitor and report on overall study progress</li><li class="leading-relaxed">Develop and maintain study timelines and ensure timely delivery of data-related milestones in collaboration with cross-functional teams and external vendors</li><li class="leading-relaxed">Oversee the creation of study-specific CDM documentation, including eCRF specifications, completion guidelines, edit check specifications, and data management plans—proactively identifying and mitigating risks to data quality and ensuring appropriate filing in the Trial Master File (eTMF)</li><li class="leading-relaxed">Manage CRO CDM counterparts to ensure compliance with scope of work, contractual agreements, timelines, and quality standards</li><li class="leading-relaxed">Conduct end-to-end testing of electronic case report forms (eCRFs), including authoring and executing User Acceptance Test (UAT) plans and scripts prior to deployment</li><li class="leading-relaxed">Develop and execute risk mitigation and action plans as needed to maintain data integrity and operational efficiency</li><li class="leading-relaxed">Actively participate in internal study team discussions and engage with external stakeholders through vendor teleconferences</li><li class="leading-relaxed">Serve as a primary liaison to internal partners (Clinical Operations, Biometrics, Safety/Pharmacovigilance, Regulatory Affairs) and external entities (CROs, third-party data vendors)</li><li class="leading-relaxed">Monitor vendor performance and quality; escalate issues to management and implement corrective actions as appropriate</li><li class="leading-relaxed">Support audit and inspection readiness activities at the study level</li></ul><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">Required Qualifications:</h2><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">At least 10 years of experience in clinical data management, including direct collaboration with CROs and data management vendors; experience in global or cross-cultural environments is preferred</li><li class="leading-relaxed">Comprehensive knowledge of FDA and ICH/GCP regulations and their application to data management processes</li><li class="leading-relaxed">Proficiency in CDISC standards (CDASH/SDTM), medical coding dictionaries, 21 CFR Part 11 compliance, and industry best practices in clinical data management</li><li class="leading-relaxed">Exceptional interpersonal, communication, and organizational abilities, with a demonstrated capacity to manage multiple programs and workflows in a dynamic, team-oriented setting</li><li class="leading-relaxed">Proven success in managing vendor relationships and functional service provider (FSP) partnerships</li><li class="leading-relaxed">Strong track record of building effective relationships and managing expectations with external partners and vendors</li><li class="leading-relaxed">Practical experience with electronic Trial Master File (eTMF) systems related to CDM documentation</li></ul><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">Preferred Qualifications:</h2><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Experience with regulatory submissions (e.g., IND, NDA/BLA, MAA) and associated data packages</li><li class="leading-relaxed">Familiarity with emerging technologies in clinical data management such as eSource, decentralized trials, and real-time data analytics</li></ul><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">Education:</h2><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Bachelor’s degree or higher in Life Science or related discipline</li></ul><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">Benefits of Working at Kailera</h2><p class="my-4 text-gray-700 leading-relaxed">In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.</p><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Comprehensive health benefits and tax-advantaged savings accounts</li><li class="leading-relaxed">Flexible time off, 13 paid holidays, and a companywide year-end shutdown</li><li class="leading-relaxed">Monthly wellness stipend</li><li class="leading-relaxed">Generous 401(k) match</li><li class="leading-relaxed">Disability and life insurance</li></ul><p class="my-4 text-gray-700 leading-relaxed">At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.</p><p class="my-4 text-gray-700 leading-relaxed">Salary Range</p><p class="my-4 text-gray-700 leading-relaxed">$160,000 - $200,000 USD</p><p class="my-4 text-gray-700 leading-relaxed"><em>EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:</em></p><p class="my-4 text-gray-700 leading-relaxed">Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.</p><p class="my-4 text-gray-700 leading-relaxed"><em>E-Verify:</em></p><p class="my-4 text-gray-700 leading-relaxed">Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.</p><p class="my-4 text-gray-700 leading-relaxed">#LI-Hybrid</p>

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Springer Nature is seeking a skilled and motivated Engineer to drive innovation in Mac and mobile device management. This role will shape the future of Apple and mobile ecosystems, mentor engineers, and collaborate across teams to enhance infrastructure and automation. The ideal candidate has deep technical expertise, leadership experience, and a passion for improving endpoint management. Responsibilities include administering Apple devices with Intune and other MDM platforms, designing mobile device configurations, developing automated workflows for provisioning and deployment, integrating applications, monitoring infrastructure, and ensuring security compliance.

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<h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">About Springer Nature Group</h2><p class="my-4 text-gray-700 leading-relaxed">Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For over 180 years our brands and imprints have been a trusted source of knowledge to these communities and today, more than ever, we see it as our responsibility to ensure that fundamental knowledge can be found, verified, understood and used by our communities – enabling them to improve outcomes, make progress, and benefit the generations that follow. Visit group.springernature.com and follow @SpringerNature / @SpringerNatureGroup</p><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">About the Role</h2><p class="my-4 text-gray-700 leading-relaxed">Springer Nature is seeking a skilled and motivated Engineer to drive innovation in Mac and mobile device management. This role will shape the future of Apple and mobile ecosystems, mentor engineers, and collaborate across teams to enhance infrastructure and automation. The ideal candidate has deep technical expertise, leadership experience, and a passion for improving endpoint management.</p><p class="my-4 text-gray-700 leading-relaxed">This role can be in our offices on a hybrid working model.</p><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">Role Responsibilities:</h2><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">Administer and manage Apple devices using Intune and other MDM platforms.</li><li class="leading-relaxed">Design and implement mobile device configurations, policies, and profiles to support business needs.</li><li class="leading-relaxed">Develop automated workflows for device provisioning, software</li><li class="leading-relaxed">Deployment, patching, and compliance checks.</li><li class="leading-relaxed">Integrate third-party and internal applications with MDM tools for seamless app delivery and management.</li><li class="leading-relaxed">Collaborate with developers and IT teams to build or support custom scripts, API and internal apps tailored for the mobile environment.</li><li class="leading-relaxed">Monitor and support mobile infrastructure to ensure high availability and performance.</li><li class="leading-relaxed">Ensure mobile devices align with corporate security and usage policies.· Create and maintain technical documentation, including architecture, Sops, and deployment guidelines.</li><li class="leading-relaxed">Troubleshoot and resolve issues related to mobile device deployments, applications, and integration workflows.</li></ul><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">Experience, Skills & Qualifications:</h2><ul class="list-disc list-inside my-5 pl-5 space-y-2 text-gray-700"><li class="leading-relaxed">6-10 years of experience in (Mac, iOS) and strong hands on with Intune.</li><li class="leading-relaxed">Master's degree / Bachelor's or equivalent degree and 6 to 10 years Engineer or Systems Administrator role</li><li class="leading-relaxed"><em>Deep expertise with JAMF Pro and Apple ecosystem (macOS, iOS).</em></li><li class="leading-relaxed"><em>Solid understanding of MDM tools (e.g., Intune).</em></li><li class="leading-relaxed"><em>Proficiency in scripting and automation (e.g., Bash, PowerShell, Python).</em></li><li class="leading-relaxed"><em>Experience building or supporting automation and app integration.</em></li><li class="leading-relaxed"><em>Understanding of API integrations and mobile application deployment.</em></li><li class="leading-relaxed"><em>Ability to work cross-functionally in a fast-paced environment with minimal</em> direction.</li><li class="leading-relaxed">ACSP(Apple certified support professional) , Jamf 100, 200, 300.</li><li class="leading-relaxed">Familiarity with Apple Business Manager, ADE, and VPP.</li><li class="leading-relaxed">Background in enterprise mobility within regulated industries.</li><li class="leading-relaxed">Experience with security and compliance frameworks in mobile environments.</li></ul><h2 class="text-2xl md:text-3xl font-bold mt-10 mb-4 border-b pb-2 text-gray-800">Eligibility</h2><p class="my-4 text-gray-700 leading-relaxed">In accordance with our internal career movement guidance, 12 months in current role is a requirement before applying to a new role</p><p class="my-4 text-gray-700 leading-relaxed">At Springer Nature, we value the diversity of our teams and work to build an inclusive culture, where people are treated fairly and can bring their differences to work and thrive. We empower our colleagues and value their diverse perspectives as we strive to attract, nurture and develop the very best talent. Springer Nature was awarded Diversity Team of the Year at the 2022 British Diversity Awards. Find out more about our DEI work here <a href="https://group.springernature.com/gp/group/taking-responsibility/diversity-equity-inclusion" target="_blank" rel="noopener noreferrer" class="text-blue-600 hover:text-blue-800 hover:underline transition-colors duration-200">https://group.springernature.com/gp/group/taking-responsibility/diversity-equity-inclusion</a></p><p class="my-4 text-gray-700 leading-relaxed">If you have any access needs related to disability, neurodivergence or a chronic condition, please contact us so we can make all necessary accommodation. For more information about career opportunities in Springer Nature please visit <a href="https://springernature.wd3.myworkdayjobs.com/SpringerNatureCareers" target="_blank" rel="noopener noreferrer" class="text-blue-600 hover:text-blue-800 hover:underline transition-colors duration-200">https://springernature.wd3.myworkdayjobs.com/SpringerNatureCareers</a></p><p class="my-4 text-gray-700 leading-relaxed">#LI-DB1</p><p class="my-4 text-gray-700 leading-relaxed">Job Posting End Date:</p><p class="my-4 text-gray-700 leading-relaxed">30-11-2025</p><h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">Why work here?</h3><p class="my-4 text-gray-700 leading-relaxed">We are an ambitious and dynamic organisation, and home to some of the best-known names in research, educational and professional publishing.</p><p class="my-4 text-gray-700 leading-relaxed">Working at the heart of a changing industry, we are always looking for great people who care about delivering quality to our customers and the communities we work alongside. In return, you will find that we open the doors to discovery for all our employees – offering opportunities to learn from some of the best in the business, with a culture that encourages curiosity and empowers people to find solutions and act on their instincts. Whether you are at the beginning of your career or are an experienced professional, we invite you to find out more about the roles we offer and explore our current vacancies.</p><p class="my-4 text-gray-700 leading-relaxed">Read More</p><h3 class="text-xl md:text-2xl font-bold mt-8 mb-3 text-gray-800">About Us</h3><p class="my-4 text-gray-700 leading-relaxed">We are a global and progressive business, founded on a heritage of trusted and respected brands – including Springer, founded in 1842, Macmillan, founded in 1843 and Nature, first published in 1869.</p><p class="my-4 text-gray-700 leading-relaxed">Nearly two centuries of progress and advancement in science and education have helped shape the business we are today. Research and learning continues to be the cornerstone of progress, and we will continue to open doors to discovery through trusted brands and innovative products and services. Springer Nature Group was created in May 2015 through the combination of Nature Publishing Group, Macmillan Education and Springer Science+Business Media.</p><p class="my-4 text-gray-700 leading-relaxed">Read More</p>

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