Vice President/Senior Vice President, 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.

What You’ll Do:

This is a critical leadership role within the medical organization. The Head of Clinical Development leads the development and execution of the global medical and scientific evidence generation strategy for our products. They solicit and incorporate cross-functional input into this strategy, translate it into an aligned vision and actionable global development plan, and are accountable for its execution. They develop key external scientific relationships with leaders in the obesity research community and interact with global regulatory authorities.

Responsibilities:

• Build, grow, and lead the global clinical development organization
• Develop and execute global development strategy and resultant evidence generation plan with incorporation of cross-functional and regional input
• Design, execute, complete, and communicate clinical trials (eg, scientific advisory boards, protocol development, regulatory and ethic committee interactions, medical monitoring, data analyses, study reports, regulatory correspondences and filings, presentations, and data dissemination)
• Deliver robust clinical trial data on-time and on-budget to inform product benefit: risk
• Interface with global medical opinion leaders in obesity to inform clinical development program and maintain engagement
• Clear, data-based communications with global regulators
• Provide clinical input to regulatory, safety, medical affairs, commercial, payer, and manufacturing colleagues

Qualifications:

• MD or equivalent
• At least 15 years of clinical development experience with proven track record of executing clinical trials and global regulatory interactions
• Experience in obesity and/or metabolic disease strongly preferred
• Prior leadership, budgeting and resource management experience required
• Uncompromising ethics, passion for teamwork and people, attention to detail, 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.

E-Verify:

Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.