Jobs at Kailera Therapeutics, Inc.

Leads late-stage biopharmaceutical programs from Phase 3 through regulatory approval and launch readiness. Oversees development strategy, cross-functional alignment, governance, risk management, milestone execution, and integrated commercial preparation. Partners with R&D, Regulatory, CMC, medical, market access, and commercial teams while representing program leadership to executive and board-level stakeholders. Builds decision-making and planning systems and leads program teams in a fast-growing biotech environment.

Leads global regulatory strategy and submissions for investigational and future marketed products, including INDs, CTAs, NDAs, and MAAs. Coordinates cross-functional preparation, reviews applications for accuracy and compliance, monitors global regulations, provides regulatory intelligence, responds to agency questions, manages risk, and develops SOPs and work instructions. The role is hub-based in Waltham, Massachusetts, onsite three to four days weekly, with 10–15% travel.

Leads operational execution of Kailera’s clinical development portfolio, with primary responsibility for Phase 3 programs through NDA submission readiness. Builds integrated plans, governance, dashboards, risk-management processes, and cross-functional alignment across Clinical, Regulatory, CMC, Medical Affairs, Commercial, and Finance. Manages and develops Program Managers, supports late-stage development strategy, presents portfolio updates to senior leadership and boards, and establishes a scalable program management office emphasizing accountability, transparency, compliance, and operational excellence.

Conducts analytical quality control, release and stability testing, method validation, data trending, and data integrity reviews in a GMP-regulated pharmaceutical environment. Maintains LIMS and stability databases, evaluates degradation pathways and temperature excursions, supports OOS/OOT investigations and CAPA analysis, authors regulatory documentation, and collaborates on analytical method lifecycle activities and submissions.

Leads statistical programming for clinical studies, regulatory submissions, and disease-area initiatives. Oversees specifications, ad hoc and post hoc analyses, CDISC-compliant SDTM and ADaM datasets, TFLs, CRO deliverables, independent validation, and quality checks. Collaborates with statisticians and cross-functional teams while managing multiple projects and deadlines.

Leads regional and global cross-functional teams in planning, preparing, and delivering compliant drug marketing authorization submissions. Owns integrated submission plans, timelines, resources, dashboards, governance updates, risk mitigation, project delivery, and submission-process best practices. Collaborates with regulatory, clinical, quality, CMC, medical writing, and technical operations teams to manage complex late-stage drug development programs and ensure NDA, BLA, and MAA submissions are completed on time, within scope, and within budget.

Leads the global clinical development organization and oversees medical and scientific evidence-generation strategy. Responsibilities include designing and executing complex clinical trials, managing budgets and resources, engaging obesity research leaders and regulators, delivering clinical data, and providing clinical guidance to regulatory, safety, medical affairs, commercial, payer, and manufacturing teams.

Reviews and approves GMP manufacturing, packaging, service provider, deviation, change control, CAPA, and quality event documentation for clinical drug programs. Prepares batch files for final disposition, supports quality system reviews, identifies and escalates quality issues, and improves GMP procedures and processes while collaborating with QA, RA, CMC, and external providers.

Leads bioanalytical strategy and execution for clinical and non-clinical drug development programs. Oversees GLP-compliant outsourced bioanalysis involving small molecules, peptides, and biomarkers; selects and manages CROs; directs assay development, validation, and implementation; reviews technical data and reports; supports regulatory submissions; and represents bioanalytical sciences on cross-functional teams.

Leads strategic scientific communications across publications, medical affairs resources, symposium content, and training materials. Oversees publication strategy, clinical publications, cross-functional reviews, agencies, writers, and vendors. Ensures communications are scientifically rigorous, accurate, balanced, compliant, and aligned with GPP, ICMJE, company policies, and industry standards. Develops scientific platforms and communication frameworks, supports governance discussions and congress preparation, and manages multiple priorities in a fast-paced environment.

Leads global product labeling and advertising promotion activities across the drug development lifecycle. Develops and maintains prescribing information, patient labeling, medication guides, IFUs, packaging labels, and promotional materials. Provides FDA and international regulatory guidance, supports FDA labeling negotiations, evaluates claims, participates in MLR review, monitors regulatory developments, and maintains compliant SOPs and governance processes. Collaborates with clinical, CMC, medical, safety, device engineering, technical operations, and commercial teams.

Leads development and commercialization of drug-device combination products, including autoinjectors, pre-filled syringes, and multidose pens. Manages requirements, design controls, risk management, verification and validation, human factors, design transfer, regulatory submissions, vendors, test laboratories, and Design History File deliverables. Coordinates cross-functionally with CMC, quality, regulatory, manufacturing, clinical, commercial, and supply chain teams while ensuring compliance with applicable FDA, ISO, IEC, and ASTM standards.

Directs cross-functional drug development programs from initiation through completion, managing integrated plans, timelines, resources, risks, dependencies, budgets, and executive reporting. Partners with clinical, regulatory, non-clinical, technical operations, and commercial teams to advance late-stage programs, including Phase 3 development, NDA filing, post-approval commitments, and commercialization planning. Ensures alignment with strategic objectives, proactively resolves issues, and drives clarity and delivery in a fast-paced biotech environment.

Supports analytical CMC program management across multiple pharmaceutical development projects. Responsibilities include coordinating vendors, tracking analytical documents, deliverables, timelines, contracts, invoices, budgets, and CMC tracking tools. The role communicates cross-functional issues, escalates risks, and manages relationships with external partners. Success requires pharmaceutical drug development experience, cross-functional collaboration, strong communication, problem-solving, and a bachelor's degree.

Leads day-to-day clinical trial management across study start-up, conduct, and completion. Oversees CROs and external vendors, reviews study plans and monitoring reports, supports clinical documentation, manages data queries and site issues, ensures study master file quality and GCP compliance, and leads internal and external clinical study team meetings.