Director, Clinical Development, Neuroscience

Responsibilities

• 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.

Requirements

• 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)

Qualifications

• Medical degree, MD or advanced degree in biological sciences e.g. PhD or Pharm D with drug development experience in Neuroscience, experience in epilepsy is highly advantageous.
• Board Certification in Neurology, or equivalent CNS training is required US licensure and/or clinical practice experience preferred.

Skills

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

Benefits

• Full and complete base pay range: $196,000.00 - $294,000.00
• Discretionary annual cash bonus or incentive compensation (depending on the role).
• Discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
• Medical, dental and vision insurance.
• 401k retirement savings plan.
• Flexible paid vacation.

Pay

• Base pay range: $196,000.00 - $294,000.00

Schedule

• Up to 5-20% travel required