Director, Clinical Development, Neuroscience jobs in United States
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Jazz Pharmaceuticals · 10 hours ago

Director, Clinical Development, Neuroscience

Jazz Pharmaceuticals is a global biopharma company dedicated to transforming the lives of patients through innovative medicines. The Director, Clinical Development, will provide leadership and medical oversight for clinical programs in neuroscience, collaborating with multidisciplinary teams to support regulatory submissions and ensure patient safety during trials.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

Clinical/scientific researchNeuroscience expertiseRegulatory submissionsPharma/biotech experienceGCP knowledgeTraining abilityLeadershipCommunication skillsCollaborationProblem solving

Required

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)
Medical degree, MD or advanced degree in biological sciences e.g. PhD or Pharm D with drug development experience in Neuroscience
Board Certification in Neurology, Psychiatry, or equivalent CNS training is required

Preferred

US licensure and/or clinical practice experience preferred

Benefits

Medical, dental and vision insurance
401k retirement savings plan
Flexible paid vacation

Company

Jazz Pharmaceuticals

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Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments.

H1B Sponsorship

Jazz Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (26)
2024 (24)
2023 (25)
2022 (31)
2021 (21)
2020 (39)

Funding

Current Stage
Public Company
Total Funding
$2.81B
Key Investors
Longitude CapitalKohlberg Kravis Roberts
2024-09-03Post Ipo Debt· $850M
2021-04-22Post Ipo Debt· $1.5B
2009-12-07Post Ipo Debt· $120M

Leadership Team

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Renée Galá
President and Chief Executive Officer
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Dennis Engelke
Executive Director, Country Manager Switzerland & Austria
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Company data provided by crunchbase