Job DescriptionPurpose:
This position supports the Clinical Trial Patient Safety (CTPS) organization to achieve its mission of
evaluating and ensuring the quality of clinical trial patient safety data by consistent and accurate delivery
of high-quality, relevant and timely data review. To create a culture of process improvement, employee
development, performance measures, project prioritization, and to develop/implement successful
solutions leading the CTPS team, translating the business vision into broad and actionable strategies.
Responsibilities:
This position is responsible for world-wide surveillance of clinical trial patient safety data, including
organization, resourcing and continuous improvement efforts. Supports Director of CTPS.
Core Job Responsibilities include:• Manages assigned operational area(s)compound associated clinical studies and related systems to
ensure clinical safety adverse event surveillance is managed in a compliant and timely manner
meeting quality outputs within an inspection-ready environment.
• Establish, monitor, evaluate, and communicate workload projections and metrics for operational
area(s).
• Supports department and divisional training programs, ongoing knowledge attainment, and
development of staff by effectively identifying department and division needs and successfully
presenting them to management.
• Creates and sustains an environment that attracts, develops, and retains talented scientific
professionals. Plans and conducts active talent management.
• Assist management with strategic planning and department development. Develop and participate in
special projects for respective teams or CTPS initiatives.
• Applies advanced knowledge of ICH, FDA, EMA regulations and guidelines affecting drug safety issues
to assigned responsibilities as they impact on CTPS processes, procedures, and global reporting
requirements.
• Partner with therapeutic area MDs/medical monitors to provide oversight of medical safety review at
the compound study level, including ad-hoc safety reports, IRB/IEC safety issues, narratives, etc.
• Provide oversight of narrative deliverables, issue management, document management systems, and
centralized data review for assigned compound associated clinical studies. Effectively
communicates/escalates relevant study and/or team-related information to appropriate clinical team
members and/or management.
• Understands, implements and improves department SOPs as part of continuous improvement,
including implementation of new regulatory requirements.
• Aligns and maintains effective communication channels with key clinical, medical, study team, including regulatory, compliance, and pharmacovigilance counterparts.
Provides perspective, insight and benchmark information and approaches for business-related initiatives.
• Manages 5 to 10 people.
Qualifications- Bachelor's degree in a healthcare discipline (i.e. Life Science, Pharmacy, Nursing or healthcare profession, or biomedical disciplines). Graduate degree preferred. 10 years of experience in clinical research in the pharmaceutical industry.
- Project management experience with cross-functional projects. Knowledge of the drug development process which includes clinical trial conduct, scientific strategy and operations management for the planning, execution and reporting of clinical development programs, regulatory requirements for submission, product launch and post marketing support.
- Experience in one or more of the following areas: clinical operations management, clinical study management, drug development, risk management, and/or drug safety operations. Understanding tools, standards and approaches to efficiently evaluate drug safety.
- Demonstrated effectiveness in working in a multidisciplinary, matrix team environment with the ability to manage change.
- Leadership and communication skills that minimally include: effective and timely communication of project objectives, issues/risks and other project information required to keep the team and management informed.
- Demonstrated sound judgment to manage conflict and negotiations constructively and develop effective working relationships to enable high performing teams.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
