AVEO is discovering and developing a pipeline of targeted therapies that address major unmet needs in oncology. Through internal drug discovery and selective partnering, AVEO is building a diversified product pipeline and moving towards its vision of becoming a fully integrated company.
In this newly created position, you will be reporting directly to the Chief Medical Officer and will be an integral member and leader of the Company’s clinical infrastructure. You will play a key role in helping advance AVEO’s novel pipeline into clinical trials.
The principal responsibility for this position is to guide the clinical development strategy and implementation of clinical trials for the Company’s novel therapeutic agent for the treatment of cachexia in cancer and potentially other disease settings. Duties will span across all aspects of clinical trial design, conduct, analysis and reporting. The Director will work closely in a team environment with staff in other functions including Research, Program Management, Clinical Operations, Clinical Pharmacology, Data Management, Biostatistics, Pharmacovigilance, Regulatory Affairs and others.
Other specific responsibilities include:
- Provide medical guidance and leadership to AVEO’s translational research group as well as regulatory affairs to ensure maximum scientific and regulatory input to study design
- Present AVEO’s clinical programs externally, at meetings with scientific, medical, regulatory (both in U.S. and Europe), and the business community.
- Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors (current and new), KOL’s, and patient advocacy groups.
- Write clinical development plans and clinical protocols for new compounds from first-in-man to regulatory approval.
- Provide clinical information required for IND’s, NDA’s, and other related documents.
- Ongoing review of clinical and safety data
- Lead a multi-disciplinary Clinical Sub-Team
Qualified candidates will have an MD or MD/PhD degrees. Board certification in Endocrinology or significant research experience in cachexia, obesity or skeletal muscle metabolism is highly desirable. Prior experience as an investigator or sub-investigator in clinical trials is essential. Candidates with prior experience in industry or academia will be considered.
Aveo Oncology - 8 months ago