Kailera Therapeutics

Lead global clinical and commercial drug supply strategy in Waltham. This director role requires 8+ years of clinical supply management expertise, including IRT systems and CDMO oversight. Enjoy comprehensive benefits, bonus potential, and equity in a collaborative, fast-paced biopharma environment.

Lead Analytical Development and QC for innovative drug programs from clinical to commercial stages. Oversee GMP release, stability, and data integrity at CDMOs for injectable and oral dosage forms. Utilize advanced analytical techniques and stability software in a key CMC role. Based in Waltham w...

Lead statistical programming for late-phase clinical trials and regulatory submissions in this Associate Director role. Oversee CROs and ensure CDISC-compliant SDTM/ADaM datasets. Leverage your 7+ years of SAS expertise in a collaborative Waltham-based team with comprehensive benefits and bonus p...

Lead global clinical supply chain operations for a biopharma leader in Waltham. Utilize your 10+ years of experience in clinical supply management and IRT systems to ensure uninterrupted investigational product supply. This hands-on role offers comprehensive benefits, bonus potential, and equity ...

Lead CMC Operations for pharmaceutical development projects in Waltham. Manage CDMO alliances, tech transfers, manufacturing, and regulatory submissions with 10+ years of industry experience. Enjoy comprehensive benefits, flexible time off, and equity in a collaborative, cross-functional environm...

Seeking an Associate Director of Clinical Quality Assurance in Waltham, MA. This hands-on role requires a GCP/GVP expert with 10+ years' experience, including Veeva systems, to ensure compliance and inspection readiness. You will implement risk-based quality management and collaborate across clin...

Seeking an experienced Medical Director for Clinical Development in Waltham. Lead clinical strategy and trial execution for innovative therapeutics in a dynamic biotech environment. An MD with 3+ years of industry experience in clinical development and trial design is required. We offer comprehen...

Gain hands-on medical communications experience in Waltham, contributing to publications, slide decks, and congress planning. Collaborate cross-functionally and lead a project to develop leadership skills. Ideal for a bachelor's candidate with strong communication skills and scientific coursework...

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...

Seeking an Associate Director of Clinical QA in Waltham, MA. This hands-on GCP/GVP expert will lead risk-based quality management, audit programs, and inspection readiness for clinical studies. Requires 10+ years in FDA-regulated industry with Veeva suite proficiency. Enjoy comprehensive benefits...