Director, CNS Clinical Development
Category: Research & Development | Country: United States | State: Pennsylvania | City: Philadelphia | Type: Regular, Full Time | Job ID: 4423
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Director, Clinical Development, will join a growing team in the therapeutic areas of Sleep Medicine and CNS. Responsibilities include clinical leadership of development programs, medical monitoring of clinical trials, contributing to CNS clinical development strategy, supporting regulatory submissions, and representing clinical development in multidisciplinary teams within R&D.
- Provide leadership and medical input for clinical programs, clinical protocols in development, ongoing clinical trials, clinical study reports and regulatory documents.
- Serve as medical monitor on trials for products under development in Sleep Medicine and CNS.
- Provide safety oversight during clinical programs and make recommendations based on safety findings to team, as needed.
- Provide strategic input on new product concepts, long-range strategic plans and licensing opportunities in CNS
- Collaborate closely with other internal team members in clinical development, clinical operations, regulatory affairs, drug safety and pharmacovigilance, and quality to facilitate the execution of 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.
- 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
- 3-5 years pharmaceutical industry experience as industry physician
- Excellent oral and written communication skills
- Knowledge of GCP, Drug Safety, MedDRA safety coding and Pharmacovigilance processes
- Collaborative and flexible in personal interactions at all levels of the company
- Ability to train other physicians a plus
- Ability to work proactively and effectively, with demonstrated creative problem solving skills
Required/Preferred Education and Licenses
- MD or DO is required
- Board Certification in Neurology, Psychiatry, or equivalent CNS training is required
- US licensure and/or clinical practice experience 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.