Executive Director, Clinical Development, Neuroscience
Company: Jazz Pharma
Location: Palo Alto
Posted on: January 13, 2021
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Job Description:
Overview:Jazz Pharmaceuticals is an international
biopharmaceutical company focused on improving patients' lives by
identifying, developing and commercializing meaningful products
that address unmet medical needs. We are continuing to expand our
commercial product portfolio and our research and development
pipeline in therapeutic areas that can leverage our unique
expertise.Our therapeutic areas of focus include sleep and
hematology/oncology - areas in which we have a deep understanding
of the patient journey and a suite of products and product
candidates to address critical needs.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.
Responsibilities:Clinical development physician who will be
responsible for a Neuroscience drug development program. This
individual may lead a multidisciplinary team which oversees several
multinational clinical studies, the interpretation of clinical
trials data, clinical interactions with multidisciplinary groups
across the company including R&D, commercial, regulatory and
business development, and with external stakeholders including
regulatory agencies and thought leaders. In addition, the lead will
contribute to the overall Jazz strategy in Neuroscience and
contribute to due diligence activities that will lead to additional
assets being brought into the Therapeutic Area and may include
oversight of a collaboration with partner companies to oversee the
joint development of multiple products. The position will require a
deep understanding of the Neuroscience therapeutic area.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*
Serve as medical monitor* 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* Partner with corporate
development on the identification of external assets to build and
strengthen the therapeutic area* Provide clinical expertise and
strategic 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* Medical degree,
MD or equivalent with specialized training in Neurology, Psychiatry
and/or Neuroscience Medicine. ; U.S. Board
Certification/Eligibility 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.
Keywords: Jazz Pharma, Palo Alto , Executive Director, Clinical Development, Neuroscience, Executive , Palo Alto, California
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