About Kronos Bio
Kronos Bio, Inc. is dedicated to the discovery and development of first-in-class therapies that modulate historically undruggable targets. We leverage deep capabilities in high-throughput small molecule microarrays (SMM), targeted protein degradation, and cancer biology in order to identify potent and selective compounds against transcription factors and other central drivers of oncogenic signaling
Essential Duties and Responsibilities:
Note: Essential functions are basic job duties that an employee must be able to perform, with or without reasonable accommodation.
Global Regulatory Leadership:
- Provide leadership on global regulatory activities with a focus on clinical regulatory filings
- Lead regulatory planning and strategy development for programs
- Guide project teams in interpretation and communication of regulatory requirements
Regulatory Submissions:
- Lead IND submission activities and ensure compliance with relevant regulatory requirements
- Oversee the preparation, review, and submission of regulatory documents including FDA submissions
- Manage and track regulatory submissions and approvals across all clinical programs
Regulatory Support:
- Provide regulatory guidance to core teams and other governance bodies
- Monitor, assess and communicate impacts of global regulations and guidances
- Support clinical trial application activities and manage regulatory aspects of clinical trials
- Coordinate with vendors (CRO, regulatory operations consultants, and other consultants) to ensure communication and deliverables are accomplished
Agency Interactions:
- Manage interactions with regulatory agencies
- Collaborate with subject matter experts to respond to regulatory inquiries
- Provide periodic status updates regarding regulatory conditions
Document Management:
- Ensure regulatory submissions are reviewed, finalized and archived appropriately
- Collaborate with relevant CROs for US eCTD IND submissions and ex-US CTAs
Necessary Experience:
Education:
- BA/BS degree in biological or physical sciences preferred
- Relevant experience including at least 6 years of regulatory science experience
Skills and Competencies:
- Proficient in written, oral, and interpersonal communications in English
- High attention to detail; ability to organize, prioritize, and delegate assigned projects.
- Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems and document review tools desirable
- Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization
- Entrepreneurial and enjoys working in a fast-paced, creative, and resourceful small company environment
- Embodies Kronos values; exhibits high degree of integrity and professionalism when interacting with colleagues and external customers
Preferred Experience:
- Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations preferred.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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