Kailera Therapeutics - Hybrid work

Join our team in Waltham as a Manager of Patient Safety and Pharmacovigilance Operations. You will oversee safety vendor activities, ensuring compliance with global PV regulations and quality standards. This role requires 6+ years of PV Ops experience, Argus database proficiency, and vendor manag...

Lead immunogenicity assessment strategy for obesity-related drug development at Kailera Therapeutics. Oversee GLP-compliant ADA bioanalysis, manage CROs, and ensure regulatory compliance. Requires a PhD and 10+ years in regulated bioanalysis. Based in Waltham with comprehensive benefits and equity.

Lead global clinical and commercial drug supply strategy in this Director role based in Waltham, MA or San Diego, CA. Utilize your 8+ years of clinical supply management expertise to ensure uninterrupted product flow, managing CDMOs and IRT systems. Enjoy comprehensive benefits including health c...

Lead global regulatory submissions as a Director, ensuring timely and compliant filings for product approvals. This strategic role requires 10+ years of experience managing complex NDAs/BLAs and leading cross-functional teams. Based in Waltham, it offers comprehensive benefits, bonus potential, a...

Lead statistical strategy for clinical development from early to late phase at our Waltham site. This director role requires 8+ years experience (PhD) guiding regulatory submissions and innovative trial design. You'll provide cross-functional leadership with a comprehensive benefits package inclu...

Lead statistical programming for late-phase clinical trials and regulatory submissions in Waltham. This role requires 7+ years of SAS/CDISC expertise and experience overseeing CROs. We offer comprehensive benefits, bonus opportunities, and equity in a supportive environment.

Lead strategic pharmacovigilance planning and drive innovation in this key Associate Director role. You will manage global PV projects, optimize processes, and integrate new technologies from concept to adoption. The position requires 10+ years in pharmacovigilance and strong project management s...

Join Kailera's growing Pharmacovigilance team as an Associate Director. You will oversee global PV operations, ensuring compliance with FDA, EMA, and ICH guidelines. This role, based in Waltham, MA or San Diego, CA, offers comprehensive benefits, bonus opportunities, and equity. Utilize your 10+ ...

Lead global clinical supply chain operations to ensure uninterrupted investigational product delivery for trials. This role requires 6+ years of clinical supply management experience, IRT system expertise, and a collaborative, results-driven approach. Based in Waltham, MA or San Diego, CA, it off...

Lead Alliance Management Operations at a dynamic biotech firm in Waltham. Utilize your 8+ years of life sciences experience to implement systems, create dashboards, and optimize strategic partnerships. This role offers comprehensive benefits, equity, and the chance to drive insight-driven decisio...

Lead clinical pharmacology strategy for obesity-related drug development at Kailera. This senior director role requires 10+ years' industry experience, deep PK/PD expertise, and regulatory submission knowledge. Based in Waltham, it offers comprehensive benefits, equity, and a chance to impact met...

Join our Non-Clinical Development team in Waltham as an Operations Manager. You will provide crucial operational support, managing study timelines, vendor contracts, and cross-functional collaboration. The role requires 6+ years in pharma/biotech ops with strong organizational and communication s...