Sr Director of Benefit-Risk Management Physician & Epidemiology
Category: Research & Development | Country: United States | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 4108
Same Job Available In Two Locations
Palo Alto, California, United States
Philadelphia, Pennsylvania, United States
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.
This position will oversee post-marketing requirements related to Medical Safety and lead the discussion and implementation of modern and innovative epidemiology approaches to evaluate the safety and ultimately the benefit-risk profile of a drug based on data from different data sources. The role will provide medical support to US Risk Evaluation and Mitigation Strategies (REMS) and global Risk Management Plans (RMPs).
Medical support for post-marketing commitments, including registries and safety observational and interventional studies.
Leads the study design of epidemiologic studies including development of study proposals. Directs design of data collection; drafts data summaries/reports of epidemiologic studies for regulatory submissions.
Independently evaluates external databases and/or other data sources including registries for study feasibility.
Actively participate in the SMT to provide lead epidemiology support and determine appropriate epidemiologic strategies to provide insight into assessment of post-marketing safety.
Provides vendor management of partner CROs contracted for safety studies.
Provides medical support for multiple REMS programs and mandatory risk management plans in Europe and ROW. Medical contribution and review of Risk Management Reports (RMRs)
Maintains knowledge/expertise of FDA’s Sentinel System and Benefit/Risk Assessment frameworks
Support daily department functions required to meet business and regulatory requirements within the team and cross-functional activities.
Maintains knowledge/expertise of existing epidemiological data sources which may be suitable to address issues involving safety of products, identification of characteristics of study populations and development of the knowledge of therapeutic areas.
Support development and submission of annual REMS Assessment Report
Required Knowledge, Skills, and Abilities
- Experience in the design, implementation and analysis of prospective, field-based epidemiologic studies as well as retrospective analyses of large administrative databases.
- Experience working successfully in cross-functional teams or in a matrix organizational structure
- Knowledge of health care delivery systems and health care databases
- Ability to strategically plan for the optimal application of epidemiological research in product development and post-marketing support
Required/Preferred Education and Licenses
- Medical degree required. Specialty Board Certification desirable.
- Doctoral degree in Epidemiology, or related discipline with at least four years of relevant experience or Master’s degree in Epidemiology with at least six years of pharmaceutical or health/life sciences experience
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.