Senior Director, Medical Review
Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
The Medical Review Clinical Safety Senior Director is responsible for medical oversight of expert review, assessment and applicable communication of individual case reports (ICSRs) arising from all DSI investigational and marketed products. In addition to oversight, the Senior Director will be external-facing DS colleague for all matters related to ICSR medical review, including management of vendors and anticipating and responding to queries/requests from regulatory inspectors. He/she collaborates effectively with cross functional team members to provide in-depth knowledge of medical review strategy, process and expert assessment.
- Overall: Provides oversight of expert medical review, assessment and communication of ICSRs in both the investigational and marketed settings. Ensures that ICSR reporting meets all relevant internal timelines, Must be able to perform all key responsibilities within the medical review team when needed with very minimum supervision. Acts as the internal contact point for all matters related to medical review of ICSRs.
- Medical Assessment: Oversees or provides medical review and assessment of ICSRs, including evaluation of the case narrative for accuracy, medical logic and completeness and review of coding and expectedness (against relevant reference documents). Uses medical knowledge, product knowledge and experience to determine potential causes of reported adverse events. Determines or confirms the company causality and authors or oversees the causality statement. As requested by management, participates in safety meetings to enhance medical assessment of adverse events of special interest or complex adverse events.
- Reporting and Regulatory Compliance: Ultimately decides if an adverse event is an expeditable report. Maintains knowledge and follows regulatory guidance, protocol requirements and department processes for proper ICSR handling. From a medical perspective, ensures that ICSRs are reported within all relevant internal timelines. Anticipates problems with compliance and creates solutions in a timely manner.
- Communication: Fosters and maintains a communication channel to Safety Management Team (SMT) or Clinical Safety physicians assigned to DSI products: communicates clinically notable adverse events to SMTs/assigned physicians; appropriately reacts to new information provided by SMTs/CS physicians. Spearheads harmonization and regular and strong communication with other DS regions in Japan and Europe. Engages other relevant stakeholders such as CROs and Clinical Operations to provide robust ICSR management. Reviews ICSR-related external communications such as analyses of similar events. Escalates problems to management.
- Quality and Training: Demonstrates both a strategic and detailed, execution oriented mindset in order to identify process improvement opportunities to ensure medical review effectiveness/optimization. Participates in safety specialist training. Reviews case line listings to ensure that coding, expectedness and medical evaluation are accurate. Develops other methods and/or remedies to ensure high quality medical review of DSI products.
- External: Manages CRO(s) from a medical safety perspective and ensures quality medical review. Anticipates and effectively responds to regulatory authority inspection requests. Develops, proposes and implements enhancements for capturing high quality ICSRs, including optimizing use of targeted questionnaires and other mechanisms.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
- Requires MD/DO degree
- Board certified or eligible
- 7 or more years of relevant experience
- Must have some relevant pharmaceutical industry experience in areas such as PV, drug safety, management of Serious Adverse Events (SAE).
- Demonstrated knowledge of pharmacology/toxicology.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.