Sr Director, Clinical Development, Neuroscience
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: June 18, 2022
Job Description:
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.
Clinical development physician or scientist who will served as the
Clinical Lead on 1 or more Neuroscience clinical studies. This
individual will lead the protocol development and is responsible
for the interpretation of clinical trials data including
interactions with multidisciplinary groups across the R and D
organization, and with external stakeholders including regulatory
agencies and thought leaders. In addition, the lead will contribute
to due diligence activities that will lead to additional assets to
expand the pipeline.Essential Functions
- Lead Neuroscience Clinical Development Product Team and Lead
cross-functional strategy for development of Neuroscience
products
- Develop and implement strategic clinical plans in alignment
with goals for the Neuroscience TA.
- Work within a matrix Research and Development organization to
drive the clinical and scientific strategy for new therapies in
Neuroscience
- Devise executive strategy to develop and implement clinical
studies for investigational medicines and new indications for
approved medicines
- Work closely with other functional areas within R&D
(clinical operations, data management, biostatistics, clinical
pharmacology, preclinical) to facilitate the execution of clinical
trials and programs
- Develop regulatory strategy in response to regulatory
guidelines and competitive intelligence in conjunction with project
team members, regulatory affairs and senior management
- Provide clinical/scientific input during the development,
execution and completion of clinical trials
- Lead preparation of clinical portions of all relevant
regulatory filings (IND, NDA, etc.) and review sections from other
functional areas
- Serve as lead medical representative with regulatory agencies
(if an M.D.)
- Serve as medical monitor (if an M.D.)
- Identify and interact with key opinion leaders and academic
organizations to assure incorporation of latest clinical thinking
and guidelines into clinical development plans
- Lead the development and implementation of
communication/education programs designed to effectively
communicate the therapeutic area to key opinion leaders,
investigators and physicians
- Lead clinical advisory board meetings to obtain strategic input
into clinical program development
- Serve as clinical (and medical) resource for clinical issues
raised by internal and external collaborators, investigators,
consultants and business development and investor contacts
- Provide clinical expertise and input on new product concepts,
long-range strategic plans and licensing opportunities
- Provide leadership to the multidisciplinary team and may manage
other members of the clinical development teamRequired Knowledge,
Skills, and Abilities
- Substantial pharmaceutical development or relevant academic
experience in Neuroscience or adjacent therapeutic areas
- Demonstrated scientific and therapeutic experience in
Neuroscience
- 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 written and verbal communication skills and proven
ability to work in an international collaborative environment
- Ability to effectively lead cross functional teams and
successfully leverage internal and external partnerships
- Excellent organizational and time management skills, ability to
lead and manage multiple complex projects
- A scientific track record demonstrated by publication record in
peer reviewed journals
- Travel required (up to 10%-20% of the time)Required/Preferred
Education and Licenses
- MDJazz 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. Associated
topics: design, engineering, manufacture, product, product manager,
production, program manager, quality
Keywords: Jazz Pharmaceuticals, Palo Alto , Sr Director, Clinical Development, Neuroscience, Executive , Palo Alto, California
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