Vice President/Senior Vice President Non Clinical Development

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.

This is a key leadership role in the medical organization. The Head of Nonclinical Development works cross-functionally to develop and drive nonclinical strategy and study execution to support the development and commercialization of our peptide-based programs for obesity and related conditions. They are responsible for the regulatory activities supporting the nonclinical development of our programs.

Responsibilities:

· Develop and execute nonclinical strategy

· Lead study design, execution, completion, and reporting

· Generate and deliver high quality, timely data packages in compliance with global regulatory requirements

· Build, manage, mentor, and refine the nonclinical organization

· Prepare and submit successful briefing packages and investigational and marketing applications

· Engage with global regulatory agencies to address scientific and regulatory nonclinical issues

· Ensure global regulatory approval of products with optimized cost-effectiveness, compliance, and risk mitigation/ continency planning

· Establish and maintain productive relationships with CROs and consultants for design, execution, interpretation, and reporting of nonclinical studies

· Provide nonclinical development guidance to management on key issues related to nonclinical discovery and development

· Budget and timelines for nonclinical studies

Qualifications:

· Master’s Degree in life science or PhD (preferred) in biology, pharmacology, pharmacokinetic or related discipline

· A least 15 years of pharmaceutical/biotech industry experience in nonclinical pharmacology, drug discovery and development

· Extensive experience in nonclinical study design and execution, global regulatory requirements (eg, FDA, EMA, MHRA, PMDA)

· Experience in authoring and reviewing regulatory documents (IND and NDA/BLA)

· Working knowledge and experience with CRO vendors and strong relationships within the nonclinical scientific community

· Leadership, organizational, budgeting and resource management, and project management skills

· Uncompromising ethics and integrity, passion for teamwork and people, solution focus, and strong communication skills

· Ability and willingness to fly at necessary altitude to get job done

· A drive for problem solving, continual learning, and attracting, mentoring, and retaining best people

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.

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