Job Description

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health.

Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kaileras mission to advance novel therapies for obesity and related conditions.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What Youll Do

The Associate Director, Global Supply Chain reports to the Senior Director, Global Supply Chain and possesses a working understanding of clinical supply management and project management practices. The Associate Director, Global Supply chain will support the Senior Director, Global Supply chain to ensure uninterrupted supply of Investigational Medicinal Product (IMP) for clinical studies as well as inventory of comparator drug products (if applicable).

Required location: Waltham, MA or San Diego, CA (hub-based, onsite 3-4 days per week)

Responsibilities

• Assist with investigational drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management
• Maintaining oversight in monitoring inventory levels throughout the life of a clinical trial
• Support with oversight of packaging and labeling/distribution vendors, including relationship management
• Coordinate the preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
• Proactively identify potential issues, notify supervisor in a timely manner, and develop mitigating actions
• Interpret clinical synopses and protocols to create clinical IMP demand forecasts
• Attend clinical study and cross functional meetings as needed
• Assist the global supply chain lead in overseeing the execution of multiple clinical trials and proactively identify potential supply chain issues and recommending solutions to global supply chain lead
• Lead clinical study close-out activities, including returned goods reconciliation and inventory destruction
• Assist with drug supply delivery through coordination of CMC efforts (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)
• Coordinate temperature excursion processes are executed as required
• Support the IRT System Leads as necessary with regards to user requirement specifications and management module(s) as applicable
• Lead organization and filing of documents on SharePoint sites

Required Qualifications

• Bachelors degree and 10+ years of relevant biopharmaceutical industry experience or advanced degree with 5+ years of experience
• 6+ years of experience in clinical supply management
• Knowledgeable in the implementation and workings of IRT systems
• Ability to create a collaborative environment and manage multiple project activities
• Hands-on, roll-up-your-sleeves, collaborative approach with high sense of urgency and drive for results
• Ability to think outside of the box and challenge the status quo
• Desire to work in a fast-paced, innovative environment
• Ability to travel up to 20%

Preferred Qualifications

• Experience with pharmaceutical development and manufacturing operations for development-stage clinical products
• Experience with combination product device(s)

Education

• Bachelors degree in pharmaceutical science, engineering, life sciences, supply chain or another relevant field or equivalent experience. Advanced degree preferred.

Salary Range

$160,000 - $200,000 USD

This range represents the companys good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grantsbecause your well-being and future matter to us.

Equal Employment Opportunity Information

Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

E-Verify

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