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.
The Senior Director, Clinical Operations is responsible for execution of clinical development plans, for defining the clinical trial strategy, implementing the overall clinical trial strategy, and management of all Phase 1-3 clinical studies being conducted by Pacira Pharmaceuticals. He/she will manage operational and logistical tasks of clinical development to ensure efficient execution of Phase 1-3 clinical trials within established budgets and timelines, ensuring all activities occur in compliance with the appropriate FDA regulations including GCP, NDA, 505(b)(1), 505(b)(2), 501 (k) regulatory pathways etc. He/she will coordinate the efforts of internal and external resources to include development and maintenance of budgets, negotiation of contracts with vendors, CROs, and clinical trials sites/ principal investigators.
The Senior Director of Clinical Research is responsible for providing clinical insight, advocate for the team members, and must possess knowledge of acute surgical procedures and hospital related practices to ensure prompt patient recruitment, clinical trial site selection, clinical trial execution and optimization with a focus on both speed and quality. He/she will provide leadership skills, proactively identify potential program challenges, come up with solution(s), and be a strong advocate for the trial manager(s)/ trial associates.
Executes clinical studies to establish the safety, efficacy and commercial viability of new products.
Participates in the formulation of overall clinical development strategy.
Experience in conduction pediatric and adult hospital based clinical research trials.
Manage Phase 1-4 clinical research and operations including strategic direction, clinical trial protocol design and initiation of clinical trials to optimize tactical and clinical value through US and Global Clinical Trial Site Selection and data portability.
Actively participates as the lead research team member interacting with and providing oversight to assure investigator compliance with the study protocols, regulatory guidelines and company standard operating procedures. Performs the function of Pacira s face, thought and conscience to the investigative community.
Manages study timelines, deadlines and budgets to include negotiating contracts with study vendors, CROs and clinical trial sites/PI s.
Works with clinical research/operations team and Regulatory Affairs in the preparation of project-related documents and regulatory submissions, including Investigator s Brochures, Annual Reports, INDs and NDAs.
Is responsible for site initiation, site oversight and monitoring, on-site presentations, site close-out, understanding adverse events, leads and coordinates a multidisciplinary team.
Communicates and interacts frequently and effectively with in-house personnel, clinical sites and outside contractors/CROs.
Participates in investigator meetings.
Develop, revise, review and implement Pacira SOPs for Phase 1-3 Clinical trials and trial related activities.
Ensure 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.
Develop and maintain professional relationships with academic and community-based physicians, clinicians and principal investigators to assure good clinical input to Pacira product development process, marketing and sales teams
Interface with departments within and outside of Pacira including Clinical Operations, Regulatory Affairs, Compliance, Pharmacovigilance, Commercial, Marketing, Medical Affairs and Sales Teams.
Provide updates and status reports to Executive/Senior Management on a regular basis to include performance against the plan.
The qualified candidate will possess the following:
Masters degree in a health, biological sciences or research related field from accredited college or university, Doctoral degree in field of study preferred
Minimum 15 years of experience in pharmaceutical / medical device industry with at least 5 years of hands-on managerial experience running clinical trials and managing teams.
Minimum 10 years experience managing clinical trials.
Minimum 10 years experience working in the CRO matrix environment managing global development program as a Lead Clinical Research Associate (CRA)/ Clinical Trial Lead (CTL) or Clinical Program Lead (CPL) preferred.
Demonstrated detailed knowledge of medical/surgical procedures, and hospital/acute care medical 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, pediatric research guidelines, European, APAC, LATAM and global Regulatory Authority Submissions etc..
Excellent written and oral English communication and presentation skills with excellent professional demeanor and presence,
Demonstrated commitment to working within Regulatory and Compliance constructs.
Strong MS Office Skills including production of GANTT charts/timelines etc.
Proven knowledge of and experience in Phase 1-4 clinical trial design and protocol development.
Demonstrated understanding of statistics and statistical methods
Excellent analytical and organization skills; able to set priorities and meet deadlines.
Ability to work effectively on a team in an entrepreneurial environment.
Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions/resolutions to problems.
Extraordinary research skills, vast experience conducting hospital based research trials and expertise in searching medical literature and databases for clinical, medical and technical information.
Proven ability to forge cross-functional working relationships with internal teams. Clinical Trial Sites/PI s, external contractors, vendors, and customers.
Demonstrated ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the clinical trial and resolve the issues in a timely fashion.
Ability to travel up to 50% with short notice when necessary.
Ability to comply with all medically required hospital/clinical site immunization requirements.
Valid driver s license in the state in which you reside.
Loading some great jobs for you...