Note: The job is a remote job and is open to candidates in USA. Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for serious diseases. The Director, Clinical Development will provide leadership and medical oversight for clinical programs in neuroscience, ensuring effective execution of clinical trials and regulatory submissions.
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
Skills
- 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)
- 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
- Experience working in a pharma/biotech company, CRO, or other clinical research related vendor preferred
- Experience in epilepsy is highly advantageous
- US licensure and/or clinical practice experience preferred
Benefits
- Discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan
- 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
Company Overview