Job Information
Jazz Pharmaceuticals, Inc. Director/Senior Director, Bioanalytical Sciences in Palo Alto, California
Director/Senior Director, Bioanalytical Sciences
Early Development
Palo Alto,
California
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Reporting to the Head of Nonclinical Development and working closely with the Head of Clinical Pharmacology, and other senior Tech Ops, Clinical Operations, Clinical Development, and Regulatory leaders of the Jazz R&D Organization, the Senior Director, Bioanalytical Sciences will be accountable for setting up the Bioanalytical strategy along with standard operating procedures, and for the outsourcing, execution, monitoring, and reporting of the clinical and nonclinical bioanalytical assays (BA) supporting pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity assessments, for the Bioanalytical components of regulatory submissions, and responding to information requests by Global health authorities and partners for the Jazz portfolio of small molecule and biologics products in support of pre-IND, IND and NDA/BLA stage development.
Essential Functions
Supervise, manage, and strategic planning with BA CROs on objectives and priority setting to deliver robust and reliable bioanalytical assays
Lead development and technology transfer of BA methods to CROs in US and externally
Lead scientific review and provide instruction on bioanalysis from CROs for CRO to provide quality data/reports within specified timelines
Evaluate work from the internal bioanalytical staff, CROs, contractors, and consultants.
Organize project meetings and manage timelines for coordinating BA and CRO work.
Represent the bioanalytical group to present bioanalytical results to project teams
Responsible for review and approval of data/report from both BA and CRO labs in coordination with the CRO Study Monitors
Contribute to the preparation of bioanalytical sections of IND/BLA documents
Contribute to addressing questions and inspections from the regulatory agencies
Provide bioanalytical input and collaborate across all functional areas, including research, preclinical, clinical development, project management, biostatics, data management, and regulatory affairs departments.
Professionally network with bioanalytical scientists in other pharmaceutical companies to be current with standard practices and regulatory issues facing bioanalytical development
Integrate quality standards to ensure data of the highest quality (e.g. GLP and GCLP compliance, accuracy, precision).
Required Knowledge, Skills, and Abilities:
A minimum of 10-15 years of industry experience in conducting bioanalytical research and development, and sample analysis for clinical and nonclinical assays.
Persuasive written and oral communications skills.
Demonstrate success in technical proficiency, scientific creativity, and collaboration with others and independent thought.
Scientific know-how: widely recognized as an expert that maintains high level of professional expertise through familiarity with scientific literature.
This candidate should be a driver of innovative scientific research and development on bioanalytics.
The individual will be a self-starter with excellent time and people management capabilities and who is seeking to be a critical part of and to help lead cross functional teams to support the company's drug development process.
Educational Requirements:
Doctoral degree (PhD) in biology, biochemistry or relevant discipline
Proficient in the use of Microsoft Word, Excel and PowerPoint
Description physical Demands:
Routine mobility within office environment.
Routine sitting for extended periods of time.
Significant travel to oversee outsourced activities.
Operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment:
Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
Frequent computer use at workstation.
May move from one work location to another occasionally.
Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
Occasional public contact requiring appropriate business apparel
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.