Director of Clinical Development, Oncology
Sacramento, CA, United States
Brief Description:
Jazz Pharmaceuticals is seeking a clinical development physician to join a team in hematology oncology drug development. You will be responsible for development of clinical studies, the oversight and interpretation of clinical trials data, clinical interactions with multidisciplinary groups across the company including R&D, commercial, regulatory, and business development, and with external stakeholders, including regulatory agencies and thought leaders.
Essential Functions
Devise strategy for, develop, and implement clinical studies for investigational medicines and new indications for approved medicines
Work closely with other functional areas within R&D (including clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to facilitate the execution of clinical trials and programs
Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjunction with project team members, regulatory affairs, and senior management
Provide clinical/scientific input during the development, execution, and completion of clinical trials
Interpret clinical trial data and prepare reports, regulatory submissions, and publications based on the results
Monitor clinical trials for safety
Work in conjunction with Product Safety to insure timely reporting of safety signals to regulatory authorities
Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, MAA, etc) and review sections from other functional areas
Serve as lead medical representative with regulatory agencies
Identify and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
Lead clinical and/or patient advisory board meetings to obtain strategic input into clinical program development
Serve as clinical and medical resource for clinical issues raised by internal and external collaborators, investigators, consultants, and business development and investor contacts
Provide clinical input on licensing opportunities
Required Knowledge, Skills, and Abilities
Demonstrated scientific and therapeutic experience
Excellent written and verbal communication skills and proven ability to work in an international collaborative environment
Experience in leading the design, conduct, analysis, and reporting of clinical studies, including interactions with regulatory agencies
Ability to work effectively in cross functional teams and successfully leverage internal and external partnerships
Excellent organizational and time management skills, ability to lead and manage multiple complex projects
Demonstration of Jazz values in previous employment
Leadership potential
Ability to work proactively and effectively using creative problem solving skills
Track record of relevant scientific publications
Travel required (up to 20%-30% of the time)
Required/Preferred Education and Licenses
MD or MD, PhD or equivalent with 3 to 5 years of relevant experience
Board certification in Oncology
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