We seek a highly motivated and experienced leader as the Chief Medical Officer to advance Allorion's programs. The successful candidate will be a key member of the Allorion leadership team and responsible for ensuring the strategic planning and execution of clinical development within timelines and budgets and with high qualities.
Responsibilities
- Oversee multiple functions, including clinical research, clinical operations, data management, project management, and regulatory
- Lead Allorion drug development project teams to define the approaches from IND, first-in-human to registration
- Build clinic development/project management team(s) and be accountable for the successful execution of the clinical development strategies and plans, from global FIH to registrational studies
- Work across a matrixed organization with Discovery Biology, Translational Medicine, DMPK/clinic pharm, Tox, and CMC to formulate the clinical development strategies
- Be responsible for the final review and sign-off of all controlled clinical documents, including protocols, IBs, informed consent forms, as well as all major written deliverables
- Lead the external forums, including regulatory interactions, scientific meetings, and partnership discussions
- Provide strategic perspective and guidance to Allorion's R&D and commercialization for discussions and decisions from clinical development standpoints
Required Skills
- MD with strong clinical research background or MD/PhD with experience in oncology
- 15+ years of industry experience with 5+ years in leading clinical development of oncology assets, with demonstrated track records in clinical development
- Experience in oncology early-stage clinical development and regulatory interactions with health authorities
- Ability to thrive in the highly entrepreneurial biotech environment, with experience in a small/medium size company
- Excellent interpersonal skills and mindset of collaboration and teamwork, and the ability to function in a highly matrixed organization
- Excellent communication skills, including presentation and writing skills, and the ability to convey information through written and verbal approaches effectively and efficiently
- Organizing and planning skills in using time effectively, meeting project deadlines, and handling multiple assignments simultaneously