What are the responsibilities and job description for the Head of Clinical Development position at Meet Life Sciences?
Meet are currently engaged with an emerging biotechnology company advancing a new generation of antibody-drug conjugate (ADC) therapies to address some of the toughest challenges in oncology. Backed by significant funding from leading life sciences investors, our client are positioned to move rapidly from discovery through clinical development and as such are looking to bring in a Development leader, to work closely with the CMO in advancing FIH studies.
Responsibilities:
- Leading clinical studies, medical monitoring oversight, and communication of accumulating data pertaining to safety and efficacy of the molecule,
- Leads and demonstrates ownership of the design and implementation of clinical development programs.
- Partner with cross functional leadership team to define key clinical milestones.
- Accoutable for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses.
- Serve as clinical expert for one or more molecules
- Responsible for understanding regulatory requirements related to the clinical studies and global drug development. Serves as a clinical representative for key regulatory discussions.
Qualifications:
- MD with a minimum of 10 years experience in oncology clinical development. Experience with ADC desirable.
- Early development experience; FIH and Ph I-II preferred
- Experience in preparing IND applications
Salary : $350,000 - $395,000
