REGISTRIEREN

Jobbörse

Finde Jobs in deiner Nähe – ob vor Ort, hybrid oder remote.
  • Ähnliche Jobs zu: Director OSP Construction (Hiring Immediately)
XX
Director, Clinical Development, Neuroscience (Hiring Immediately)Jazz Pharmaceuticals • Philadelphia, Pennsylvania, United States
Jetzt Bewerben
XX

Director, Clinical Development, Neuroscience (Hiring Immediately)

Jazz Pharmaceuticals
  • US
    Philadelphia, Pennsylvania, United States
  • US
    Philadelphia, Pennsylvania, United States
Jetzt Bewerben

Über

If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to life-changing medicines for people with serious diseases — often with limited or no We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. 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. 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). 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., Review publication-related materials on Jazz Pharmaceuticals sponsored studies. 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. 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 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, e
xperience in epilepsy is highly advantageous. Board Certification in Neurology, or equivalent CNS training is required US licensure and/or clinical practice experience preferred LI-remote Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. Internal equity considerations will also influence individual base pay decisions. The successful candidate may also be eligible for a 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, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.
  • Philadelphia, Pennsylvania, United States

Sprachkenntnisse

  • English
Hinweis für Nutzer

Dieses Stellenangebot stammt von einer Partnerplattform von TieTalent. Klick auf „Jetzt Bewerben”, um deine Bewerbung direkt auf deren Website einzureichen.