Vice President, Global Drug Safety

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 Kailera’s 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 You’ll Do:

The Head of Drug Safety/Pharmacovigilance will be responsible for establishing and leading the company’s drug safety and pharmacovigilance strategy. This individual will play a pivotal role in ensuring the safety of Kailera’s therapies from pre-clinical development through commercialization. The successful candidate will have extensive experience in drug safety, preferably with a background in the metabolic or cardiovascular therapeutic areas and will be responsible for building and leading a high-performing drug safety team.

Responsibilities:

· Strategy Development: Lead the development and execution of the company’s drug safety and pharmacovigilance strategy, ensuring alignment with regulatory requirements and corporate objectives.

· Safety Monitoring: Oversee all aspects of safety signal detection, evaluation, and risk mitigation strategies for all products in the clinical and commercial pipeline.

· Team Leadership: Build and lead a growing pharmacovigilance and drug safety team to meet the expanding needs of the organization, fostering a collaborative and high-performance culture.

· Regulatory Compliance: Ensure that the company is in compliance with all applicable global safety regulations, including FDA, EMA, and other relevant regulatory agencies.

· Collaboration: Work closely with cross-functional teams, including Clinical Development, Regulatory Affairs, and Medical Affairs, to ensure patient safety is embedded throughout the product lifecycle.

· Risk Management Plans: Develop, implement, and maintain risk management plans, safety monitoring plans, and safety data exchange agreements for clinical programs and marketed products.

· Clinical Trial Support: Provide pharmacovigilance expertise to clinical development teams, contributing to the design, conduct, and oversight of clinical trials with a focus on patient safety.

· Post-marketing Surveillance: Lead post-marketing surveillance activities, ensuring the collection and assessment of adverse event data for marketed products.

· External Engagement: Serve as the primary point of contact for pharmacovigilance interactions with regulatory authorities, external partners, and safety advisory boards. Coordinate efforts with clinical development, commercial, and payer organizations to ensure successful launch and commercialization

Qualifications:

· MD required, with specialty training in metabolic or cardiovascular diseases highly preferred.

· Minimum of 15 years of experience in pharmacovigilance and drug safety roles in the biotech or pharmaceutical industry.

· Proven leadership experience, with a track record of building and leading high-performing teams.

· Strong understanding of global safety regulations, including FDA, EMA, and ICH guidelines.

· Experience managing drug safety across both clinical development and post-marketing stages.

· Experience in metabolic and/or cardiovascular therapeutic areas is a strong plus.

· Excellent leadership, communication, and problem-solving skills.

· Ability to work collaboratively with cross-functional teams and senior leaders.

· Strong analytical skills with the ability to interpret complex data and make data-driven safety decisions.

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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