Senior Director, Clinical Development, Oncology (Remote)

Brief Description:

The Senior Director, Clinical Development, Oncology will play a key role in the development of Jazz’s Oncology pipeline with a particular focus on solid tumor Oncology assets and programs.  The Senior Director, Clinical Development, Oncology will be involved in protocol development, protocol review, trial and study design and will also need to provide strategic input into new and ongoing Oncology programs.  Working in a cross functional environment, it will be essential for the Senior Director, Clinical Development, Oncology to lead and partner with diverse cross functional teams to drive towards outcomes that will deliver life changing medications for the patients we serve.

Essential Functions/Responsibilities:

• Support execution and implementation of the Global Development Plan by providing strategic for assigned studies and programs
• Provide clinical/scientific input during the development, execution and completion of clinical trials; assist in reviewing and authoring study concept documents and clinical study protocols
• 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.
• Help to identify clinical investigators and coordinate activities for the conduct of clinical trials and advisory board meetings
• Review clinical study data; identify and evaluate study data trends, outliers, and protocol deviations; work with data management to issue and resolve queries to ensure data quality; work with the study medical monitor to ensure safety of study participants.
• Interpret clinical trial data and prepare reports, regulatory submissions and publications based on the results.
• Provide input on clinical presentation slides for internal/external meetings and communications (e.g., investigator meetings, pre-study site selection visits, site training, study newsletters, communication to sites, etc.)
• Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, MAA, etc) and review sections from other functional areas; serve as a medical representative with regulatory agencies.
• Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjunction with project team members, regulatory affairs and senior management.
• 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 medical resource for clinical issues raised by internal and external collaborators, investigators, consultants, business development and investor contacts. 
• Participate in the cross-functional team meetings and address study or other program-specific questions
• Read and interpret scientific and medical literature for the use in clinical documents and to assist clinical team decision-making

Required Knowledge, Skills, and Abilities:

• 5 years of pharmaceutical development experience in oncology.
• Demonstrated scientific and therapeutic expertise in oncology.
• Proven ability to work independently and as part of a multidisciplinary team
• Experience in leading the design, conduct, analysis and reporting of clinical studies, including interactions with regulatory agencies.
• Excellent written and verbal communication skills and proven ability to work in an international collaborative environment.
• 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.
• Ability to work proactively and effectively, with creative problem-solving skills.
• Travel up to 10%-20% of the time 

Required Education and Licenses:

• Medical degree (MD)
• Experience in solid tumor oncology preferred