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If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visitwww.jazzpharmaceuticals.comfor more information.
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.Â
- 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 timeÂ
Required Education and Licenses:
- Medical degree (MD)
- Experience in solid tumor oncology preferred
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.
FOR US BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $288,000.00 - $432,000.00
Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.
