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.
Jazz Pharmaceuticals is seeking a clinical development associate director to join a team in hematology oncology drug development. You will be responsible for development of international clinical studies, the oversight and interpretation of clinical trials data, clinical interactions with multidisciplinary groups across the company including R&D, commercial, regulatory and business development, and with external stake-holders including regulatory agencies and thought leaders.
This opportunity is available in both Palo Alto, CA and Philadelphia, PA
- Provide clinical/scientific input during the development, execution and completion of clinical trials
- Interpret clinical trial data and prepare reports, regulatory submissions and publications based on the results
- Monitor clinical trials for safety
- Work in conjunction with Product Safety to insure timely reporting of satefy signals to regulatory authorities
- Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, MAA, etc) and review sections from other functional areas
- Devise strategy for, 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 conjuction with project team members, regulatory affairs and senior management
- Serve as medical representative with regulatory agencies
- Identify and interact with key opinion leaders and academic organizations toassure incorporation of latest clinical thinking and guidelines into clinical development plans
- Participate in 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
Required Knowledge, Skills, and Abilities
- Demonstrated scientific and therapeutic expertise
- Experience in leading the design, conduct, analysis and reporting of clinical studies, including interactions with regulatory agencies
- Experience of interactions with regulatory agencies
- Excellent written and verbal communication skills and proven ability to work in an international collaborative environment
- Ability to work effectively in cross functional teams and successfully leverage internal and external partnerships
- Excellent organizational and time management skills, ability to lead and manage multiple complex projects
- Five plus years experience in clinical development
- Demonstration of Jazz values in previous employment
- Ability to work proactively and effectively, with creative problem solving skills
- Travel up 10%-20% of the time
Required/Preferred Education and Licenses
- Medical degree, MD or equivalent (DO, PharmD, PhD), and or experience in hematology/oncology preferred
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.