Kailera Therapeutics - Research and Development

Join our biometrics team in Waltham, USA, as a Biostatistics Summer Intern. Apply your statistical expertise using SAS, R, or Python to support innovative clinical study designs and data analysis. Gain hands-on pharmaceutical industry experience while collaborating with expert biostatisticians. T...

Lead global CMC regulatory strategy for drug development and commercialization in this director-level role. Based in Waltham, you will manage submissions, ensure compliance, and provide strategic guidance. The position requires 10+ years of CMC experience and offers comprehensive benefits, bonus ...

Lead the scientific execution of Phase I-III trials as a hands-on Director, Clinical Scientist. Partner with Clinical Operations to ensure high-quality trial conduct, rigorous data review, and clear communication. This senior role in Waltham requires 8+ years of experience and offers comprehensiv...

Lead non-clinical safety strategy as a Senior Director of Toxicology in Waltham. Utilize your 10+ years of expertise and regulatory success with INDs/NDAs to guide complex programs. This strategic role offers comprehensive benefits, bonus potential, and equity while ensuring scientific and operat...

Lead pharmacovigilance quality and compliance for a global biotech in Waltham. This senior role requires 8+ years of PV experience, expertise in global regulations (FDA, EMA, ICH), and a strong background in audits and quality systems. Enjoy comprehensive benefits, flexible time off, and equity i...

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 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 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 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...