Jazz Pharmaceuticals is seeking a clinical development physician to join a team in hematology oncology drug development. You will be responsible for development of international 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 stake-holders including regulatory agencies and thought leaders.
- 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 (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 conjuction 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 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
- Five plus years of pharmaceutical development experience in hematology/oncology
- Demonstrated scientific and therapeutic experience
- Experience in preparation of NDAs/BLAs to US and European regulatory agencies
- 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 10%-20% of the time)
Required/Preferred Education and Licenses
- Medical degree, MD or equivalent, with extensive experience in hematology/oncology
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.