Director (MD) Clinical Development Neuroscience
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: July 17, 2021
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global
biopharmaceutical company whose purpose is to innovate to transform
the lives of patients and their families. We are dedicated to
developing life-changing medicines for people with serious diseases
- often with limited or no therapeutic options. We have a diverse
portfolio of marketed medicines and novel product candidates, from
early- to late-stage development, in neuroscience and oncology. We
actively explore new options for patients including novel
compounds, small molecules and biologics, and through cannabinoid
science and innovative delivery technologies. Jazz is headquartered
in Dublin, Ireland and has employees around the globe, serving
patients in nearly 75 countries. For more information, please visit
www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
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.
- 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
- Design, prepare and initiate Study Concept Documents,
study protocols, and other required documentation in compliance
with the GDP, federal regulations, GCP, and good medical
- Act as medical monitor for company sponsored
- Support project teams with therapeutic area specific
- 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
- Help identify clinical investigators and coordinate their
activities for the conduct of clinical trials and advisory board
- Work closely with other functional areas within R&D
(clinical operations, data management, biostatistics, clinical
pharmacology, nonclinical) to facilitate the execution of clinical
- 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
- Maintain the highest level of scientific and clinical
/clinical trial outcomes knowledge in relevant disease specific
- 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
Required Skills and Abilities
- Proven ability to effectively work in a
- 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
- 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
- Strong interpersonal, influencing, presentation, and
written and verbal communication skills.
- Strong organizational and time management
- Collaborative and flexible in personal interactions with high
- 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
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.
Keywords: Jazz Pharmaceuticals, Palo Alto , Director (MD) Clinical Development Neuroscience, Other , Palo Alto, California
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