Director, Clinical Development, Neuroscience
Jazz Pharmaceuticals, California, Missouri, United States, 65018
Director, Clinical Development – Neuroscience
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, 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 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 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.
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 e.g. PhD or Pharm D with drug development experience in Neuroscience.
Board Certification
#J-18808-Ljbffr
Essential Functions
Provide leadership and medical/scientific 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 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 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 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.
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 e.g. PhD or Pharm D with drug development experience in Neuroscience.
Board Certification
#J-18808-Ljbffr