Director, Clinical Data ManagementWaltham, Massachusetts

Director, Clinical Data ManagementAt 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. 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.What You'll Do:The Director of Clinical Data Management plays a key role within Clinical Development Operations, providing strategic oversight for outsourced late-phase clinical trials. This individual is accountable for ensuring the timely delivery and high-quality execution of Data Management deliverables. In this role, the Director collaborates closely with key study stakeholders to define and implement a clear, comprehensive data strategy for assigned programs and studies. They work in partnership with DM project leads at Kailera and external CROs to drive efficient execution. The Director also manages the DM budget in coordination with program management and contributes deep data management expertise to support global development efforts. This position reports directly to the Head of Clinical Data Management.Preferred location: Waltham, MA (onsite or hybrid 2-3 days per week).Responsibilities:Lead vendor oversight activities across global development programs within late phase, ensuring alignment between the Kailera and CRO on all data management related deliverablesProvide program-level leadership and oversight of clinical data management activities; monitor and report on overall program/study progressRepresent the Data Management function on the program/project team, fostering collaboration and clear expectationsDevelop and maintain program/project timelines and data deliverables in partnership with internal team and external vendorsProvide strategic input into governance discussions with Kailera's key vendors; partner with stakeholders to resolve issues escalated by vendors or internal teamsEnsure all Data Management Trial Master File (TMF) documentation is archived properly and is inspection-readyIdentify risks proactively and develop and implement mitigation or corrective action plans as neededManage external Data Management budget planning in partnership with Head of Clinical Data Management and Program team—monitoring accuracy, evaluating variance trends, and driving continuous improvement in forecasting practicesMonitor vendor performance and quality metrics, escalate issues to management, and support resolution strategiesContribute to audit readiness by supporting study-level inspection preparation effortsRequired Qualifications:Minimum of 10 years of clinical data management experience, including direct collaboration with CROs and Data Management vendors; experience in global and cross-cultural environments is preferredProven success in managing vendor relationships and functional service provider (FSP) partnershipsIn-depth understanding of FDA and ICH/GCP regulations and guidelines related to data capture and data management processes; strong familiarity with CDISC standards (CDASH/SDTM), medical dictionary coding, 21 CFR Part 11, and industry best practicesExceptional interpersonal, communication, and organizational skills, with the ability to oversee multiple programs and workflows in a dynamic, team-oriented settingDemonstrated experience with eTMF systems and documentation requirements related to Data ManagementSolid expertise in electronic data capture (EDC) systems and clinical data warehousing technologies; experience working with a variety of clinical data management platformsAdvanced knowledge of the end-to-end drug development process, with a strong understanding of cross-functional interfaces impacting the data management functionPreferred Qualifications:Experience with regulatory submissions (e.g., IND, NDA/BLA, MAA) and associated data packagesFamiliarity with emerging technologies in clinical data management such as eSource, decentralized trials, and real-time data analyticsEducation:Bachelor's degree or higher in Life Science or related disciplineBenefits of Working at Kailera: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.Comprehensive health benefits and tax-advantaged savings accountsFlexible time off, 13 paid holidays, and a companywide year-end shutdownMonthly wellness stipendGenerous 401(k) matchDisability and life insuranceAt 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.Salary Range $175,000 - $230,000 USDEqual Employment Opportunity Information: 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.E-Verify: Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.