Description
A rapidly growing oncology company based out of Los Angeles and San Francisco is seeking a Vice President of Clinical Development. Reporting to the Chief Medical Officer the position is responsible for helping to establish the oncology development, working collaboratively with members of the development team in establishing the clinical development for a oncology compound anywhere from the pre-IND setting to pivotal trials and registration, partnering with research colleagues in assessing nonclinical candidates, and working with business development colleagues in assessing potential drug candidates for in-licensing. The position is also accountable for providing medical guidance during the design, execution, and reporting of clinical studies. The candidate will work within the project team structure, sitting on core project teams to guide strategy, and working within relevant sub-teams to ensure tactical alignment and execution.The optimal candidate will demonstrate leadership qualities with significant knowledge and experience in successfully designing and running Global Phase III oncology trials, analyzing pharmacokinetics, safety and efficacy data and advancing drug candidates through preclinical, clinical stages, BLA/NDA submissions, and Advisory/Scientific Committee Meetings. The candidate will have managed teams in the past.
Qualifications
- MD with a minimum of 10- 15 years of demonstrated knowledge and experience in Oncology Clinical Development in an industry setting. Breast, Lung oncology experience strongly preferred.
- Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
- Proven scientific writing skills and good communication skills
- Demonstrated ability to effectively manage a cross functional team
Responsibilities
- Apply subject matter expertise towards formulation of clinical development plans, including selection of the proof of concept indication.
- In collaboration with appropriate team members (e.g., clinical pharmacology, statistics, translational medicine), is responsible for the design and authorship of study protocols and interpretation of clinical study data.
- Conduct medical monitoring and data listing reviews
- Author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
- Participate in preparation for and conduct of meetings with Healthcare Authorities
- Participate in the development and delivery of protocol training for investigator site and staff.
- Contribute to the clinical development plan for compound, including review of the pre-clinical package after soliciting appropriate input, review and endorsement from key stakeholders for go/no-go development decision criteria
- Organize and prepare for Advisory Board meetings
To find out more about Real please visit www.realstaffing.com