Director (MD) Clinical Development Neuroscience - Ben Lomond - job 853491

Jazz Pharmaceuticals

Date: 06/11/2021

City: Ben Lomond, California

Employment type: Full-time

Overview:


Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.



We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.


Position Profile:


In collaboration with the Jazz clinical teams and clinical scientist(s), the primary role is to lead and execute early/late stage clinical trials for development products in the neuroscience space. Participates in the design/planning of clinical studies and helps with the interpretation of study results. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Responsibilities also include adverse event monitoring/safety signal assessments and clinical trial safety responsibilities. Coordinates and develops reporting information for reports submitted to the FDA. Participates in investigator training, site training, advisory board preparation, protocol generation, clinical study report generation, etc. Monitors adherence to protocols and oversees study completion.


Essential Functions


  • Participates in the cross-functional team meetings and addresses study or other program-specific questions.

  • Develops the Global Development Plan (GDP) with other clinical team members for assigned molecule(s)/indication(s) and/or other programs.

  • Design, prepare and initiate Study Concept Documents, study protocols, and other required documentation in compliance with the GDP, federal regulations, GCP, and good medical practice.

  • Act as medical monitor for company sponsored trials.

  • Support project teams with therapeutic area specific information.

  • Collaborate with internal safety group in analyzing and reporting of safety data from clinical trials.

  • Analyze and interpret other clinical trial data and prepare reports for regulatory agencies and publication.

  • Help identify clinical investigators and coordinate their activities for the conduct of clinical trials and advisory board meetings.

  • Work closely with other functional areas within R&D (clinical operations, data management, biostatistics, clinical pharmacology, nonclinical) to facilitate the execution of clinical trials.

  • Review clinical study data; identify and evaluate study data trends, outliers, and protocol deviations.

  • Review, interpret, and approve safety and efficacy data in clinical study reports.

  • Write protocol summaries, process documents, investigator brochures, etc. in collaboration with cross-functional groups.

  • Provide input on clinical presentation slides for internal/external meetings and communication (e.g., investigator meetings, pre-study site selection visits, site training, study newsletters, communication to sites, etc.).

  • Participate and develop communication strategies for existing and concluded studies through KOL interactions, advisory boards, scientific and industry conferences and meetings, and publications.

  • Maintain the highest level of scientific and clinical /clinical trial outcomes knowledge in relevant disease specific area.

  • 5+ years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic experience including clinical trial work but without experience in the pharmaceutical industry may be considered.

  • Hands-on experience in the design, execution, and reporting of early/late stage clinical trials in neuroscience.


Required Skills and Abilities

  • Proven ability to effectively work in a cross-functional/matrix environment.

  • Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.

  • Develops technical and/or business solutions to complex problems.

  • Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.

  • Leads or manages the work of others by providing guidance to team members based on organizational goals and company policy, with responsibility for results.

  • Ability to develop and maintain relationships with significant KOLs.

  • Strong interpersonal, influencing, presentation, and written and verbal communication skills.

  • Strong organizational and time management skills.

  • Collaborative and flexible in personal interactions with high emotional intelligence.

  • Travel opportunities (up to 5-20% of time).


Required/Preferred Education and Licenses


  • MD with board certification in Neurology, Psychiatry, or equivalent CNS training is required.

  • US licensure and/or clinical practice experience preferred.


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.





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