Kailera is a late clinical-stage biotechnology company advancing a diversified pipeline of GLP-1 therapies to provide options for people living with obesity. Backed by a16z.
About the role
Vice President of CMC Regulatory will lead all aspects of CMC Regulatory. Reporting into the Senior Vice President of Regulatory, you will provide strategic and operational leadership to ensure the effectiveness of the CMC Regulatory team and the integrated CMC team. With their lead candidate planning to initiate Phase 3, the candidate must plan for and have extensive drug development expertise. The company offers innovative science, competitive compensation, and a patient-focused company culture. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 15+ years of biopharmaceutical industry experience, with 10+ years of relevant Regulatory CMC
- Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
- Ability to motivate and lead others, both with direct line and within integrated team
- Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
More about this role
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.
Vice President of CMC Regulatory will lead all aspects of CMC Regulatory. Reporting into the Senior Vice President of Regulatory, you will provide strategic and operational leadership to ensure the effectiveness of the CMC Regulatory team and the integrated CMC team. With their lead candidate planning to initiate Phase 3, the candidate must plan for and have extensive drug development expertise. The company offers innovative science, competitive compensation, and a patient-focused company culture.
Required location: Waltham, MA (hub-based, onsite 3-4 days per week) OR Remote (home-based,...
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