Senior Director/Vp Clinical And Translational Development

Our client is a dynamic, growing biotech with a antibody discovery platform, which it is using to develop therapies for cancer.

We seek an experienced drug developer to lead a small team (4-6 people) in clinical development and operations, translation and regulatory activities.

• Provide leadership to both internal team members and external partners such as CROs.
• Manage the regulatory team and ensure successful interactions with the US, and other international bodies.
• Provide practical leadership to the team, giving guidance through proactive discussions with research and development team members and appraising performance whilst seeking continuous improvements.
• Orchestrate preclinical development activities from IND-enabling study CRO selection, management of non-GLP and GLP studies to IND submission in collaboration with RA.
• Spearhead clinical development activities up to human PoC stage, including the design and operation of global clinical trials, writing of clinical protocols, selection of CRO’s etc.

You should have

• Experience leading multifunctional teams in drug development.
• Able to work onsite in Boston
• History of successful interactions with FDA
• Proven experience designating and executing Phase 1 clinical trials- ideally for Oncology.
• Willingness to manage a pre clinical team.