Director of Clinical Development, Oncology

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

At Jazz, we believe that effective people leadership is essential to our success. Our people managers play a vital role in creating an environment where teams thrive, and individuals reach their full potential. Jazz invests in people managers to ensure they are equipped to drive performance, grow individuals and create belonging. As a result, Jazz people managers champion a culture of collaboration, inclusion, and belonging; ensuring that everyone feels heard and valued. They connect with their teams on a personal level, understanding their unique needs and motivations and providing personalized support to empower every team member to thrive.