Director, Clinical Development, Neuroscience

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceutical sis 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.jazz pharmaceuticals.comfor more information.

Brief Description

The Director, Clinical Development, will join a growing team in the therapeutic areas of Neuroscience. Responsibilities include clinical leadership of development programs, medical monitoring of clinical trials (if MD), contributing to CNS clinical development strategy, supporting regulatory submissions, and representing clinical development in multidisciplinary teams within R&D.

Essential Functions

• Provide leadership and medical/scientific input for clinical programs, clinical protocols in development, ongoing clinical trials (Phase 2, Phase
  3) , clinical study reports and regulatory documents.

• Serve as medical monitor on trials for products under development in CNS/neurology (if MD or appropriate per role).

• Provide clinical oversight during clinical programs and make recommendations based on findings to team, as needed.

• Provide strategic input on new product concepts, long-range strategic plans and licensing opportunities in CNS.

• Collaborate closely within clinical development and with cross-functional team members including in clinical operations, regulatory affairs, drug safety and pharmacovigilance, and quality to facilitate the execution of phase 2 and phase 3 clinical trials and programs.

• Collaborate closely with study investigators on clinical trial eligibility and subject and patient safety issues.

• Engage external experts to obtain scientific input into clinical program development.

• Prepare clinical data and clinical program presentations

• Review, interpret, and approve safety and efficacy data in clinical study reports, regulatory documents and submissions related to clinical trials (e.g., IND and NDA).

• Review publication-related materials on Jazz Pharmaceuticals sponsored studies.

Required Knowledge, Skills, and Abilities

• Clinical/scientific research experience required, with neuroscience expertise, epilepsy expertise preferred.

• Experience working in a pharma/biotech company, CRO, or other clinical research related vendor preferred.

• Ability to effectively lead cross functional teams and successfully leverage internal and external partnerships

• Experience in preparation of regulatory submissions (INDs and NDAs) to US and European regulatory agencies. Lead preparation of clinical portions of relevant regulatory documents.

• Excellent oral and written communication skills.

• Knowledge of GCP, drug safety, MedDRA safety coding, and pharmacovigilance processes (as appropriate per role).

• Collaborative and flexible in personal interactions at all levels of the company.

• Ability to train other physicians/scientists a plus.

• Ability to work proactively and effectively, with demonstrated creative problem solving skills.

• Travel required (up to 5-20% of time)

Required/Preferred Education and Licenses

• Medical degree, MD or advanced degree in biological sciences…