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Kailera Therapeutics

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Senior Director, Toxicology

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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...
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Location
United States , Waltham
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Salary
210000.00 - 270000.00 USD / Year
Expiration Date
Until further notice

Senior Manager, Patient Safety and Pharmacovigilance Quality

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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...
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Location
United States , Waltham
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Salary
136000.00 - 170000.00 USD / Year
Expiration Date
Until further notice

Manager, Patient Safety and Pharmacovigilance Operations

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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...
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Location
United States , Waltham
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Salary
110000.00 - 140000.00 USD / Year
Expiration Date
Until further notice

Director, Senior Medical Science Liaison

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Join Kailera as a Director, Senior Medical Science Liaison to build Field Medical Affairs from the ground up. Leverage your 6+ years of MSL experience and deep obesity/metabolism expertise to shape strategy and engage KOLs. This field-based role offers up to 80% travel, comprehensive benefits, an...
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Location
United States
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Salary
175000.00 - 230000.00 USD / Year
Expiration Date
Until further notice

Director, Immunogenicity Assessment

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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.
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Location
United States , Waltham
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Salary
175000.00 - 230000.00 USD / Year
Expiration Date
Until further notice

Director, Global Supply Chain

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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...
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Location
United States , Waltham, MA or San Diego, CA
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Salary
175000.00 - 230000.00 USD / Year
Expiration Date
Until further notice

Director, Global Regulatory Affairs (Submission Project Management)

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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...
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Location
United States , Waltham
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Salary
175000.00 - 230000.00 USD / Year
Expiration Date
Until further notice

Director, Biostatistics

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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...
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Location
United States , Waltham
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Salary
175000.00 - 230000.00 USD / Year
Expiration Date
Until further notice

Associate Director, Statistical Programming

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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.
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Location
United States , Waltham
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Salary
160000.00 - 200000.00 USD / Year
Expiration Date
Until further notice

Associate Director, Pharmacovigilance Planning and Innovations

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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...
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Location
United States , Waltham
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Salary
160000.00 - 200000.00 USD / Year
Expiration Date
Until further notice

Associate Director, Integrated Pharmacovigilance Operations

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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+ ...
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Location
United States , Waltham, Massachusetts; San Diego, California
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Salary
160000.00 - 200000.00 USD / Year
Expiration Date
Until further notice

Associate Director, Global Supply Chain

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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...
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Location
United States , Waltham, MA or San Diego, CA
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Salary
160000.00 - 200000.00 USD / Year
Expiration Date
Until further notice
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