Working alongside an exciting clinical-stage biopharmaceutical company who focuses on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. Currently, the team is searching for a Vice President, Clinical Development to be responsible for creating and executing clinical development plans.
Recently, the hiring company announced positive topline results from its Phase 1b/2a trial and also recently iniated it's Phase 2 proof of concept study which is associated with patients who are at risk for NASH, NAFLD, and cardiovascular diseases.
As a leader in the company, this role will be reporting to the Chief Medical Officer and will play a key role in leading the clinical development for their trials, collaborating with internal and external stakeholders, as well as managing Clinical Pharmacology and Drug Safety. Line management of clinical development, clinical pharmacology, and drug safety will be given.
This is one of my most exciting positions! Having a relationship with the team already, I have received impressive feedback regarding the team's culture and emphasis on empowering members to truly own their work.
- Prepare clinical development plans; preclinical and early clinical findings
- Delivery of development projects
- Design cost effective protocols that are aligned with the clinical development plan
- Oversight of medical directors and management of clinical development process from protocol development to study execution and reporting documentations
- Provide medical input and contribute to the clinical development sections of regulatory documents such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues
- Reporting SAEs on a global basis
- MD; board certification preferred
- 5+ years of Phase 2 and 3 clinical development experience including 2+ years leading other clinical development Director+ level professionals
- Experience working in Dyslipidemias, Cardiovascular Diseases or Diabetes disease areas preferred
- Must have worked in a Vice President role previously
- Experience developing/reviewing clinical development plans and regulatory documents