Other Locations:US- NJ- Summit East
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Reporting to the Senior Director – Trial Safety Science, Hematology / Oncology, the Senior Manager is responsible for safety surveillance activities for compounds in clinical development and for post-marketed products during the implementation and execution of clinical trials, through review of data from multiple sources, including clinical trial and safety databases, and the literature to support the following: clinical protocols, informed consent forms, Investigator’s Brochures, Safety Management Teams, and other safety evaluations.
Responsibilities will include, but are not limited to, the following:
- Supports the strategy for surveillance activities and recommends revisions to the study monitoring plan, as needed.
- Supports / contributes to signal assessment and ad hoc regulatory safety requests by analyzing data from the clinical trial and global safety database as well as literature, and utilizing clinical judgement to determine the impact of the safety issue on the product’s benefit/risk profile in close collaboration with the Lead Product Safety Physician.
- Drives the communication of findings of surveillance activities and safety assessments to a variety of audiences, including the Study Team, Safety Management Team (SMT), and management, to inform on necessary risk minimization activities, including label changes.
- Contributes to the strategy, authoring and review of aggregate safety reports (PSUR/DSUR) in accordance with regulatory requirements and standard operating procedures.
- Contributes to annual or ad hoc Investigator’s Brochure updates.
- Coordinates the management and preparation for safety meetings including SMT / DMC preparation, documentation, and logistical support.
- Reviews study-related documents such as Informed Consent Forms (ICFs), protocols, and Case Report Forms, and applicable safety management plans.
- Authors Case Management Workaids, safety sections of the protocols & Clinical Study Reports, Standard Risk Language for ICFs, risk/benefit assessment for EU CTAs, and as appropriate the Company Core Data Sheet and Risk Management Plan.
- Generates SAE report form, pregnancy report form, completion guidelines.
- Provides safety training to site and study personnel, and responds to ad hoc Investigator / IRB / EC Queries.
- Reviews study-specific Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables, listings & graphs [TLGs]), and contribute to the safety strategy for the CSR.
- Supports various process improvement and cross-functional initiatives for both Trial Safety Science and GDRSM, which may include contributing to the development and periodic update of SOPs and Work Practices.
- Contributes to safety activities between Trial Safety Science and internal / external partners; represents GDSRM in internal and external cross-functional settings.
- Pharmacy/Nursing (e.g., BS, MS, PharmD) or other degree with the equivalent combination of relevant education and professional experience
- At least four years of relevant clinical experience, including training
- Five years of biotech/pharma experience of which three should be in safety or clinical development/operations
- Working knowledge of the following: GCP & ICH Regulations, global safety environment, electronic data collection in clinical trials, and international regulations and guidance documents
- Good understanding of the drug development lifecycle, from clinical development through post-approval
- Ability to utilize clinical judgement and interpret medical safety data to assess safety issues within the context of the product’s benefit/risk profile
- Well-developed oral and written communication skills with the ability to manage multiple studies across compounds/projects simultaneously
- Experience working in a cross-functional environment
- Experience manipulating, understanding, and integrating large and complex data sets from multiple sources to answer specific questions
- Basic Project Management skills and MS Office Suite skills
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.