This position will be responsible for executing studies in translational sciences, including the identification of predictive disease models, establishing PK/PD/efficacy relationships, progressing the use of predictive and pharmacodynamic biomarkers, and further the understanding of drug mechanism of action in preclinical and clinical settings to drive the discovery and development of Jazz products and candidates. The position focuses on exploratory prognostic and PD biomarker identification and assessment in preclinical and clinical samples in rare diseases.
- Represents Pharmacology function on Global Project Teams and develops overall nonclinical strategy to support activities for Jazz Products in development. May serve as team member and/or team leader for major pharmacology activities.
- Independently design and execute experiments to elucidate efficacy, biomarkers of efficacy, mechanism of action of small molecule drugs and biologic products to guide life cycle management activities, with focus on synthesis, analyses of experimental outcomes, and presentation of data in various forums to guide drug development activities.
- Participates in evaluation of new internal portfolio expansion opportunities, external due diligence activities, review of external grant and funding requests/reports.
- Responsible for and contributes to development and review of the pharmacology sections of relevant regulatory documents and filings.
- Develops strong working relationships with CROs for outsourcing of pharmacological model development, evaluation of mechanism of action and therapeutic potential of Jazz candidates
- In collaboration with Medical Affairs, develops partnerships with academic labs for investigator initiated research with Jazz-Marketed products
Required Knowledge, Skills, and Abilities
- 8-10 years of industry experience in directing preclinical research model development, and investigation of therapeutic potential of drug candidates.
- Expertise in hematology, oncology, CNS disorders/behavior is a plus.
- Experience with the pharmacology and translational sciences such as development of disease models, evaluation of mechanism of action, PK/PD/efficacy relationships, exploratory prognostic /predictive and pharmacodynamic biomarker identification development and assessment and drug mechanism of action of small molecule drugs and biologic products in preclinical and clinical settings.
- Ability to work effectively both independently and collaboratively in a dynamic, team-oriented and matrix-managed environment.
- Strong leadership skills, high ability to self-start, and desire and competence to network widely within Jazz, with the scientific community, and with regulatory agencies.
- Experience in outsourcing non-GLP pharmacology studies and managing in the spirit of GLP compliance at a contract laboratory.
- An ability to integrate preclinical and clinical data is essential, as is an ability to innovate and explore new science
- Excellent analytical skills with experience in biomarker data analysis.
- Strong working knowledge of MS Office, MS Project and GraphPad Prism.
- Must be detail oriented with strong documentation and organizational skills.
- Excellent written and oral communication skills
- Excellent contingency planning and time management skills and demonstrated ability to manage a number of projects simultaneously
- Strong problem solving and analytical skills, and be capable of independent and creative thinking
- Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
- Embody and model Jazz core values
Required/Preferred Education and Licenses
- Education Doctoral degree (PhD) in biology, biochemistry or relevant discipline
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly 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.