Director, Clinical Development –Hematology/Oncology

Director, Clinical Development – Hematology and Oncology Clinical Development

The Director, Clinical Development, will join a growing team in the therapeutic areas of Hematology and Oncology Clinical Development. The candidate 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/Responsibilities

• Work with the Global Clinical Lead to 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
• Evaluate pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications.
• Monitor and manage the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs.
• Analyze and summarize the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication;
• Provide clinical/scientific input during the development, execution, and completion of clinical trials
• Work in conjunction with Product Safety to ensure timely evaluation and reporting of safety signals to regulatory authorities
• Assist and contribute to clinical portions of all relevant regulatory filings (IND, NDA, MAA, etc) and review sections from other functional areas
• Help identifying and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
• 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 Oncology 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
• Experience and expertise in oncology clinical development, especially previous similar experience in pharmaceutical industry is required; Board certification in Oncology is preferred, but not mandatory.