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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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