Senior Director, Clinical Operations

DescriptionAbout 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 anindividual 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.Supervisory Responsibilities:Matrix supervisory responsibility over a variety of clinical operations personnel as well as consultants.Interaction:The incumbent works closely with internal and external partners to provide Clinical Operations expertise.Education and Experience:•    Bachelor’s degree in Health Science, Pharmacy or Life Sciences from accredited college or university, or equivalent experience; advanced degree preferred.•    Minimum 15 years of experience in pharmaceutical / medical device industry with at least 12 years of hands-on managerial experience running clinical trials and managing teams.•    Experience in conduct of hospital or clinic-based clinical research trials; pediatric experience preferred.Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Knowledge, Skills, and Abilities:•    Demonstrated experience leading Clinical Operations to deliver on-time, on-budget high quality outcomes supporting the Clinical Development portfolio.•    Demonstrated knowledge of medical/surgical procedures, and acute and chronic pain practices (pain management standards and guidelines preferable but not essential).•    Demonstrated, solid working knowledge of cGCP, ICH and other relevant clinical development regulations and processes to include appropriate FDA regulations including NDA, 505(b)(1), 505(b)(2), 510 (k) regulatory pathways, European and global Regulatory         Authority Submissions etc. Knowledge of pediatric research guidelines is preferred.•    Demonstrated commitment to working within Regulatory and Compliance constructs.•    Excellent written and oral English communication and presentation skills with excellent professional demeanor and presence.•    Strong MS Office Skills.•    Excellent analytical and organization skills; able to set priorities and meet deadlines.•    Ability to work effectively on a team in an entrepreneurial environment with proven ability to forge cross-functional working relationships with internal teams. •    Strong project planning, leadership and negotiation skills as well as an ability to contribute creative yet practical solutions/resolutions to problems.•    Demonstrated ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of clinical trials and resolve the issues in a timely fashion.•    Ability to travel up to 20% with short notice when necessary.Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop.  Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.  Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.The ability to function independently utilizing remote office tools and work in a team environment; requires occasional travel to company locations and may require occasional on-site presence at clinical trial sites.Benefits:     Medical, Prescription, Dental, Vision CoverageFlexible Spending Account & Health Savings Account with Company matchEmployee Assistance ProgramMental Health ResourcesDisability CoverageLife insuranceCritical Illness and Accident InsuranceLegal and Identity Theft ProtectionPet InsuranceFertility and Maternity Assistance401(k) with company matchFlexible Time Off (FTO) and 11 paid holidaysPaid Parental LeaveEEO Statement:

Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.

At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.

Agency Disclaimer:
Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.