Vice-President of Translational Research

???? Vice-President of Translational Research – California ????

CM Life Science has partnered with an exciting clinical stage start-up who are advancing the development of new biologics for cancer treatment. The company raised over $150 million in their Series B funding round this year, led by some renowned VCs. The company are looking for a Head of Translational Research to report directly to their CDO.

Role Responsibilities:

• Responsible for leadership and management of Translational Research
• Identifies required translational research activities and partners with UCLA, USC, and other labs to ensure research is completed to support research and development.
• Coordinates with research labs to ensure reports and summaries are delivered to support INDs, BLA, and other regulatory filings (regulatory consultants are available)
• Partners with clinical science, medical, and operations to design, conduct, and report clinical studies
• Support appropriate interpretation and external communication of translational research data to investigators, regulators, IRBs, investors, analysts, etc
• Provide input on prioritization and validation of new pipeline assets and in partnership with other functions, designs and develops rationale development plans
• Supports preparation of regulatory filings and respond to regulatory agencies from translational research perspective.
• Supports financing and business development activities from translational research perspective

Role Requirements:

• PhD, MD, PharmD with 10+ years experience in translational research in oncology
• Extensive experience with translational research in oncology drug and diagnostic discovery and development
• Proficient knowledge of biology, oncology, INDs, drug development, regulatory, study design, statistics, biomarkers, pharmacokinetics, and operations in order to lead translational research
• Experience managing translational research aspects in outsourced nonclinical and clinical studies
• Ability to work independently, be self-motivated, set priorities, handle multiple tasks and projects with a high degree of efficiency and professionalism in a fast-moving start-up environment
• Extensive knowledge of US FDA/EMA drug/diagnostic device development process, regulations, and guidelines. Previous experience working with CDER, CBER and CDRH is strongly preferred. (External regulatory experts in drug and diagnostic have been retained to assist)

Please apply via LinkedIn or via email to harry.aaronson@lifesci-cm.com