Director, Clinical Development, Neuroscience
Jazz Pharmaceuticals
5 hours ago
Remote friendly (Philadelphia, PA)
United States
Clinical Research and Development
Director, Clinical Development (Neuroscience)
Responsibilities / Essential Functions
- Provide leadership and medical/scientific input for clinical programs, protocols, ongoing trials, clinical study reports, and regulatory documents.
- Serve as medical monitor on CNS/neurology trials (if MD or appropriate per role).
- Provide clinical oversight during clinical programs and make recommendations based on findings.
- Provide strategic input on new product concepts, long-range strategic plans, and licensing opportunities in CNS.
- Collaborate with clinical operations, regulatory affairs, drug safety/pharmacovigilance, and quality to execute clinical trials and programs.
- Collaborate with study investigators on clinical trial eligibility and subject/patient safety.
- Engage external experts for 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 and regulatory submissions (e.g., IND and NDA).
- Review publication-related materials for sponsored studies.
Required Knowledge, Skills, and Abilities
- Clinical/scientific research experience with neuroscience expertise.
- Pharma/biotech, CRO, or clinical research vendor experience preferred.
- Ability to lead cross-functional teams and leverage internal/external partnerships.
- Experience preparing regulatory submissions (INDs/NDAs) to US and European agencies; lead clinical portions of relevant documents.
- Excellent oral and written communication.
- Knowledge of GCP, drug safety, MedDRA safety coding, and pharmacovigilance (as appropriate).
- Collaborative, flexible, proactive, and effective problem solving skills.
- Ability to train other physicians/scientists (plus).
- Travel required (up to 5–20%).
Education / Licenses
- Medical degree (MD) or advanced degree (e.g., PhD or PharmD) with drug development experience in Neuroscience.
- Board Certification in Neurology, Psychiatry, or equivalent CNS training required.
- US licensure and/or clinical practice experience preferred.
Benefits (as stated)
- Eligible for medical, dental, and vision insurance; 401(k) retirement savings plan; flexible paid vacation.
Application instructions
- Current Jazz employees: apply via the Internal Career site.
Responsibilities / Essential Functions
- Provide leadership and medical/scientific input for clinical programs, protocols, ongoing trials, clinical study reports, and regulatory documents.
- Serve as medical monitor on CNS/neurology trials (if MD or appropriate per role).
- Provide clinical oversight during clinical programs and make recommendations based on findings.
- Provide strategic input on new product concepts, long-range strategic plans, and licensing opportunities in CNS.
- Collaborate with clinical operations, regulatory affairs, drug safety/pharmacovigilance, and quality to execute clinical trials and programs.
- Collaborate with study investigators on clinical trial eligibility and subject/patient safety.
- Engage external experts for 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 and regulatory submissions (e.g., IND and NDA).
- Review publication-related materials for sponsored studies.
Required Knowledge, Skills, and Abilities
- Clinical/scientific research experience with neuroscience expertise.
- Pharma/biotech, CRO, or clinical research vendor experience preferred.
- Ability to lead cross-functional teams and leverage internal/external partnerships.
- Experience preparing regulatory submissions (INDs/NDAs) to US and European agencies; lead clinical portions of relevant documents.
- Excellent oral and written communication.
- Knowledge of GCP, drug safety, MedDRA safety coding, and pharmacovigilance (as appropriate).
- Collaborative, flexible, proactive, and effective problem solving skills.
- Ability to train other physicians/scientists (plus).
- Travel required (up to 5–20%).
Education / Licenses
- Medical degree (MD) or advanced degree (e.g., PhD or PharmD) with drug development experience in Neuroscience.
- Board Certification in Neurology, Psychiatry, or equivalent CNS training required.
- US licensure and/or clinical practice experience preferred.
Benefits (as stated)
- Eligible for medical, dental, and vision insurance; 401(k) retirement savings plan; flexible paid vacation.
Application instructions
- Current Jazz employees: apply via the Internal Career site.