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
Thepurposeof this positionisto provide medical support for clinical/medical issues that impact the full clinical development spectrum for the assigned program. The job will include the design of clinical development plans, clinical trial synopses, protocols as well as responsibility for the medical monitoring of ongoing clinical trials including medical evaluation of adverse events and drug safety. The position will work seamlessly with Clinical Operations, Pharmacovigilance, Data Management, Biostatistics and Regulatory Affairs as well as other groups within the organization (Commercial, Business Development) to ensure the appropriate dispersal of information within the company and, as necessary, with external advisors.
The position will also be responsible for the medical evaluation/ interpretation of assigned clinical trials. It requires an understanding of the therapeutic context of the clinical program and an ability to discuss hypotheses with experts, investigators, and other hospital staff. The incumbent will play a key role in the identification of investigators and building/ maintaining relationships with opinion leaders.
Essential Duties Responsibilities
The following statementsareintendedtodescribethegeneralnatureandlevelof work beingperformedbyanindividualassignedtothisjob.Otherdutiesmaybeassigned.
- Responsible over the global clinical development strategy within the device portfolio for the assigned product development.
- Assist in providing strategic and tactical leadership to the Clinical Development Department to conduct the necessary clinical trials (Phase I-IV) needed to establish the safety and effectiveness of a product in major world markets. Activities include clinical program design, protocol design and implementation, data analysis, report writing, safety oversight, and interface with major regulatory agencies worldwide.
- Lead and manage the clinical development function to ensure that clinical research activities are conceived, planned, and implemented in a timely manner to achieve corporate goals.
- Identify and develop appropriate SOPs that further the department’s efforts to maintain an effective organization that excels in planning, implementing, summarizing, analyzing, and reporting results of clinical trials.
- Participate in the preparation and maintenance of appropriate documents, including protocols, amendments, Investigator Brochures, SOPs, case report forms, clinical aspects of regulatory submissions, literature reviews, scientific papers, and presentations.
- Prepare the Clinical Development Plan and key documents (e.g., medical sections of Regulatory documents, IB)
- Act as medical lead for Scientific Steering Committee Boards, establish and maintain a Thought Leader global network and other external stakeholders, in collaboration with the strategy identified within Clinical Development, Medical Affairs, and Business Development;
- Provide clinical input and support (e.g., communication of clinical strategy and results) in Health Authority interactions as needed.
- Responsibility for all medical aspects of study design, with appropriate support as needed.
- Responsibility for medical monitoring of clinical studies.
- In partnership with the Pharmacovigilance team, provide medical evaluation of pharmacovigilance and safety reports (pre- and post-marketing).
- Assist in the execution of clinical studies to establish the safety, efficacy, and commercial viability of new products.
- Actively participate in study management with the cross functional clinical team (Clinical Operations, Pharmacovigilance, Data Management, Biostatistics and Regulatory Affairs) to ensure the team will achieve key study milestones including timeline and ensure high data quality from the clinical studies assigned.
- Interface with project team members including: Clinical Operations, Data Management, Biostatistics, Pharmacovigilance and Regulatory Affairs.
- Assist with study vendor selection and education.
- Responsibility for medical monitoring portion of site initiation, with appropriate support as needed, for site oversight and monitoring, on-site presentations, site close-out and especially understanding of adverse events.
- Communicate and interact effectively with in-house personnel, clinical sites and outside contractors/CROs.
- Participate in the integration of clinical findings into commercial messaging, including work as part of publications group and sales training.
- Take an active role in budget planning and monitoring.
- Responsibility for coordinating early development and preclinical IND/IDE enabling activities both within the company and through external vendors and CROs.
- Represent the company at academic, medical industry and regulatory meetings.
- Serve a teaching role in investigator meetings and in-house education.
- Participate in the formulation of overall clinical strategy.
- Assist in the due diligence activities for Business Development initiatives.
- Provide scientific input to in-licensing product opportunities and provide rationale, timing, and budgeting information to formulate eventual decision to license.
- Assist with the safety review of all products including those in the experimental phase of development and in the post marketing phase.
Supervisory Responsibilities
Thisposition may have supervisory responsibility.
Interaction
Theposition works most closely with clinical development, biometrics, clinical operations , pharmacovigilance, regulatory colleagues, and CROs to assure the timely and effective medical oversight of clinical trials.
Education And Experience
- MD, DO, or equivalent from anaccredited college or university; b oard certification in a relevant therapeutic area (e.g., Neurology, Rheumatology, Anesthesiology, Physiatry, Orthopedics) a plus.
- PhD and/or medical subspecialty certification a plus.
- At least 2 years of clinical practice experience, academic experience a plus.
- At least6 years clinical researchexperiencein the U.S. biotech/pharmaceutical industry. Academic environment and CRO experience will be considered.
- In-depth knowledge and experience with the pharmaceutical and/or device clinical development and US regulatory environments, ex-US experience a plus.
- Demonstrated experience in developing clinical development documents e.g., clinical study protocols and reports, Regulatory submission modules (e.g., Clinical Overview, Summary of Clinical Efficacy, Summary of Clinical Safety), Medical Review reports, Pediatric Investigation Plan, Pediatric Study Plan, etc.
Qualifications
To perform this job successfully, an individual must beabletoperformeach essential duty satisfactorily. The requirements listed beloware representative of the knowledge, skill and/orabilityrequired. Reasonable accommodations may be made toenable individuals with disabilitiestoperform the essential functions.
Knowledge, Skills, AndAbilities
- Experience in clinical research.
- Knowledge of all aspects of the drug and/or device development process.
- Sound knowledge of GCP/ICH Guidelines and other relevant clinical development regulations and processes.
- Ability to work both independently and with multidisciplinary teams.
- Experience working in a team/matrix entrepreneurial environment with a “roll up the sleeves” approach.
- Excellent planning, organizing, and executing skills.
- Proven ability to be results driven and consistently meet deadlines.
- Excellent written and oral English communication and presentation skills.
- Must possess a sense of urgency and exhibit potential for mentoring others.
- Demonstrated managerial and leadership skills in a dynamic environment running multiple clinical trials.
- Must possess a personal desire and ability to lead in a progressive and innovative manner with an emphasis on the accomplishment of timely results and proactive planning.
- Thisposition may require on-site presence at clinical trial sites when feasible.
Physical Demands
While performing the duties of this job, the employee is regularly required to sit, talk, move betweenspaces,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. Will need to lift and move boxesofpaper and binders weighing up to20 pounds. Thisposition requires considerable hospital presence and requires the abilityto walk and stand for periodsof time.
Work Environment
The work environmentcharacteristicsdescribedherearerepresentativeofthoseanemployeeencounterswhileperformingtheessentialfunctionsofthisjob.Reasonableaccommodationmaybemadetoenableindividuals with disabilitiestoperformtheessentialfunctions.
Benefits
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave
