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Jazz Pharmaceuticals is a global biopharmaceutical leader committed to innovating and transforming the lives of patients and their families. Our mission is anchored in developing groundbreaking medicines for those facing serious diseases, often without adequate treatment options. We offer a rich portfolio of marketed medications, including leading therapies for sleep disorders and epilepsy, and we are expanding our range of cancer treatments. Our patient-centric and science-driven ethos fuels significant advancements in research and development across our extensive pipeline of innovative oncology and neuroscience therapeutics. With our headquarters located in Dublin, Ireland, and multiple global research and development labs, manufacturing plants, and workforce, we are devoted to serving patients worldwide. For further details about us, please visit our website.

Brief Overview:

The Senior Director of Clinical Development within our Oncology division is pivotal in advancing Jazz’s Oncology pipeline, particularly concentrating on solid tumor assets and programs. This role encompasses protocol development, thorough reviews, trial design, and providing strategic insights into both new and ongoing Oncology initiatives. Operating in a collaborative, cross-functional environment, the Senior Director will lead and collaborate with diverse teams to achieve our goal of delivering transformative medications to the patients we support.

Key Responsibilities:

• Drive the implementation and execution of the Global Development Plan by delivering strategic insights for assigned studies and programs.
• Offer clinical and scientific expertise throughout the development, conduct, and completion of clinical trials; assist in drafting and reviewing study concept documents and clinical protocols.
• Collaborate closely with various functional departments within R&D (including clinical operations, data management, and pharmacology) to ensure effective execution of clinical trials.
• Identify and engage clinical investigators while coordinating activities for clinical trials and advisory board meetings.
• Analyze clinical study data to detect trends, outliers, and protocol deviations; work with data management to resolve queries and guarantee data integrity; partner with study medical monitors to ensure participant safety.
• Assess clinical trial data and prepare comprehensive reports, regulatory submissions, and publications based on findings.
• Contribute to the creation of clinical presentation materials for both internal and external engagements (e.g., investigator meetings, site training, newsletters).
• Oversee the clinical sections of all relevant regulatory documentation (IND, NDA, MAA, etc.) and review contributions from other departments; act as a medical representative for regulatory bodies.
• Establish regulatory strategies aligned with regulatory guidelines and market intelligence, in partnership with project team members and senior management.
• Engage with key opinion leaders and academic institutions to integrate the latest clinical perspectives into development plans.
• Facilitate clinical advisory board meetings to gather strategic guidance on clinical program development.
• Act as a medical resource for clinical inquiries posed by internal and external stakeholders, including investigators and investors.
• Participate in cross-functional team discussions and address queries relating to specific studies or programs.
• Analyze and interpret scientific and medical literature to inform clinical decisions and document preparation.

Required Qualifications and Abilities:

• Minimum of 5 years of experience in pharmaceutical development within oncology.
• Proven scientific and therapeutic knowledge in the field of oncology.
• Demonstrated ability to perform both independently and collaboratively within multidisciplinary teams.
• Extensive experience overseeing the design, execution, analysis, and reporting of clinical trials, including engagements with regulatory agencies.
• Exceptional written and verbal communication skills, with a track record of thriving in an international collaborative setting.
• Strong organizational and time management capabilities; adept at leading multiple complex projects.
• Proactive and effective problem-solving skills, with a creative approach.
• Willingness to travel 10%-20% as needed.

Educational Background and Licenses:

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

Jazz Pharmaceuticals is proud to be an equal opportunity/affirmative action employer, and we welcome all qualified applicants. We value diversity and recognize the importance of inclusion in our workplace, ensuring consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

For Candidates Located in the US Only

At Jazz Pharmaceuticals, we strive for transparency in compensation and are committed to offering competitive total compensation packages. For this position, the overall base salary range is from $288,000.00 to $432,000.00. The final compensation will depend on various factors such as qualifications, skills, relevant experience, and job knowledge.

In addition to base salary, the successful candidate may be eligible for a discretionary annual cash bonus or incentive compensation in accordance with our Global Cash Bonus Plan or similar programs, and possible equity grants as per Jazz’s Long-Term Equity Incentive Plan.

The successful candidate will also have access to a comprehensive benefits package including, but not limited to, medical, dental, and vision insurance, a 401k retirement savings plan, and flexible paid vacation. For further details about our benefits offerings, please click here.