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Senior Director, Clinical Operations
Pacira BioSciences, Inc.Parsippany, United Statesfull_timeVerifiedPosted 23 Jul 2024
About the role
About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Why work with us? Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together. Summary:
Reporting to the Executive Director, Clinical Operations, this individual is responsible for execution of clinical development plans, defining and implementing clinical trial strategy, and oversees the operations of all Phase 1-4 clinical studies conducted by Pacira Biosciences. He/she will manage operational and logistical tasks of clinical operations to ensure efficient execution of Phase 1-4 clinical trials within established budgets and timelines, ensuring all activities occur in compliance with appropriate regulations. The Senior Director, Clinical Operations participates in clinical trial execution and optimization with a focus on both speed and quality and will proactively identify potential program challenges and develop solutions while providing leadership and acting as a strong advocate for the Clinical Operations team members. Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an
individual assigned to this job. Other duties may be assigned.
Matrix supervisory responsibility over a variety of clinical operations personnel as well as consultants.
Interaction:
The incumbent works closely with inter
Reporting to the Executive Director, Clinical Operations, this individual is responsible for execution of clinical development plans, defining and implementing clinical trial strategy, and oversees the operations of all Phase 1-4 clinical studies conducted by Pacira Biosciences. He/she will manage operational and logistical tasks of clinical operations to ensure efficient execution of Phase 1-4 clinical trials within established budgets and timelines, ensuring all activities occur in compliance with appropriate regulations. The Senior Director, Clinical Operations participates in clinical trial execution and optimization with a focus on both speed and quality and will proactively identify potential program challenges and develop solutions while providing leadership and acting as a strong advocate for the Clinical Operations team members. Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an
individual assigned to this job. Other duties may be assigned.
- Participates in the execution of Phase 1-4 clinical trials within established budgets and timelines, ensuring all activities occur in compliance with appropriate regulations.
- Participates in the formulation of overall Clinical Operations strategy.
- Participates in and/or oversees the evaluation, acquisition, development and maintenance of processes and systems to support Clinical Operations, including development, revision and review of departmental SOPs, as well as inspection readiness initiatives.
- Contributes to departmental and responsible for trial-level budgets including forecasting, accruals, etc.
- Responsible for Pacira Pharmaceuticals compliance with all applicable regulatory standards related to US and global clinical trials and interactions with physicians including but not limited to Sunshine Act.
- Support the Executive Director with assignment of appropriate departmental representation on Project Teams, Study Teams and cross-functional initiatives. Responsible for identification of innovative solutions that enable efficiency, effectiveness, and quality that help drive the clinical development process.
- Interface with departments within Pacira including Clinical Development, Regulatory Affairs, Compliance, Pharmacovigilance, Data Management, Biostatistics and Quality Assurance, and develop relationships with external parties including investigative sites, CRO/vendors and KOLs.
- Contribute to the development of scalable capabilities that will allow for future growth with a view toward identifying core/non-core activities and a plan to retain those of strategic importance in-house.
- Support the Executive Director in development of CRO sourcing strategy (including core/non-core definition) specific to Clinical Operations; actively work towards improvements over time that drive improvements in time, cost and quality.
- Responsible for/contribute to the Clinical Operations team’s preparation of project-related documents and regulatory submissions, including Investigator’s Brochures, Annual Reports, INDs and NDAs.
- Support the Executive Director in providing updates and status reports to Executive/Senior Management on a regular basis to include performance against the plan.
- Leader, motivator and developer of talent for Pacira Biosciences.
- Other duties as assigned.
Matrix supervisory responsibility over a variety of clinical operations personnel as well as consultants.
Interaction:
The incumbent works closely with inter
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