Associate Director, Safety Science
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.
The Associate Director is responsible for safety surveillance activities for compounds in clinical development and for post-marketed products during the implementation and execution of clinical trials, and submission of global dossiers.
Clinical Trial Support:
- Serves as the compound lead for several compounds and may oversee the operational execution of all safety-related clinical trial activities
- May lead the strategy for surveillance activities, signal assessment, and regulatory safety requests for multiple compounds and/or key registrational clinical trials (in development or investigator-initiated).
- May participate in SAE reconciliation.
- May oversee and completes study-level activities (as needed): generation of Case Management Workaids, safety sections of the protocols & Clinical Study Reports, risk/benefit assessment for EU CTAs, protocol/CRF review, ICF, Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables, listings & graphs [TLGs]).
- Oversees the development of trial related documents.
- Leads the management and preparation for DMC preparation, documentation, and logistical support.
- Reviews study-specific Statistical Analysis Plan (SAP) and statistical outputs (e.g. tables, listings & graphs [TLGs]), and contribute to the safety strategy and key safety messages for the CSR.
- May lead signal detection and ad hoc regulatory safety requests by obtaining data from the clinical trial and global safety database as well as literature, and assist the Lead Product Safety Physician in determining the impact of the safety issue on the product's benefit/risk profile.
- Leads the logistics/coordination of Safety Management Team (SMT)/Product Safety Review Meeting (PSRM) meetings, maintains roster, calendar, minutes/communication and preparation of materials, in support of the LPSP.
- Drafts materials and preparation of CSC meetings.
- Authors or provides content for safety sections of documents such as Investigator's Brochures, aggregate safety reports (PSUR/DSUR), annual reports, Standard Risk Language for ICFs, Company Core Data Sheet and Risk Management Plans
- Provides support for the lead safety physician in the strategy and authoring of integrated submission documents.
- Obtains and reviews integrated safety outputs by analyzing data from the clinical trial and global safety database as well as literature, in conjunction with the lead product safety physician across multiple compounds.
- Assists the lead product safety physician with the management of the product's benefit/risk profile.
- Lead preparation for regulatory inspections with evaluation of current processes and documentation, and may serve as the SME.
- Liaise with all TA staff and maintain an effective and collaborative product safety team.
- Trains and mentors junior safety scientists and/or other safety staff.
- Leads various process improvement and cross-functional initiatives for both Safety Science and GDRSM, including SOPs and Work Practices.
- Leads various process improvement and cross-functional initiatives for both Safety Science and GDRSM, which may include authorship of SOPs and Work Practices.
- Leads interactions with key line functions in support of safety activities between Safety Science and clinical R&D, Biostatistics, Data Management, Trial Management, Medical Affairs, or Safety Information Management.
- Lead Product Safety Physicians
- Clinical Operations
- Data Management
- Clinical Research Scientists
- Medical Writing
- Case Management / LDSO
- Global Medical Affairs
- Regulatory Affairs
- Clinical Quality Assurance
Participate and/or provide input to materials and strategies at meetings including but not limited to:
- SMT - Safety Management Teams
- DMC - Data Monitoring Committees - internal or external
- Product Development Team
- Clinical Study Team
- Risk Management
- Advanced scientific (e.g., BS, MS, PhD, PharmD) or other degree with the equivalent combination of relevant education and professional experience
- At least 6-8 years of relevant pharmaceutical industry experience; of which at least 4 years in safety or clinical development/operations is required
- Good understanding of the US and EU regulatory approval process
- Direct involvement in the development of various dossiers including NDA/sNDA, BLA/sBLA, MAA and review/authorship of briefing books
- Experience in aggregate safety data presentation, analysis, interpretation and writing, including CSR preparation
- Utilization of clinical judgement and ability to interpret medical safety data to assess safety issues within the context of the product's benefit/risk profile
- Thorough knowledge in GCP & ICH Regulations, global safety environment, electronic data collection in clinical trials, and international regulations and guidance documents
- Excellent presentation and communication skills with the ability to manage multiple projects simultaneously with minimal supervision
- Experience working in a cross-functional environment
- Proficiency in ARISg, Business Objects, data review tools, MedDRA coding, SMQ
#LI-POSTCelgene 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.