Associate Director, Clinical Contracts/Budget

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 position provides clinical trial contracts and budget expertise to Clinical Development Operations at Pacira BioSciences. The position will need to frequently interact with legal, as well as other constituents within Pacira and externally to ensure complete alignment with respect to contract development and execution for clinical trials and related agreements.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.

• Negotiate contracts, change orders, and renewals
• Create standards for vendors, including governance and oversight model, tools, templates
• Aid the Clin Ops team in finding the best available vendors
• Participate in vendor governance meetings
• Coordinates the development and agreement of the site MSA/CSA
• Accountable for the site negotiation and execution of site clinical trial agreements and budgets within agreed upon terms
• Assist in resolving negotiation barriers and issue resolution to ensure timely execution of CTAs
• Review site consent form template revisions to verify consistency with the site budget and CTA.
• Interface with legal to facilitate and resolve any contracts negotiation items
• Escalates budget and contract related issues to the project team and/or management, and assists in resolution
• 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.
• 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.
• Support the Executive Director in providing updates and status reports to Executive/Senior Management on a regular basis to include performance against the plan.
• Facilitate and maintain relationships between Pacira Biosciences and vendors/partners.
• Other duties as assigned.

Supervisory Responsibilities:This position may have supervisory responsibilities.Interaction:The incumbent works closely with internal and external partners to provide clinical trial contracts expertise.Education and Experience:

• Bachelor’s degree from accredited college or university, or equivalent experience; advanced degree preferred.
• Minimum 10 years of experience in pharmaceutical / medical device industry
• Experience in conduct of hospital or clinic-based clinical research trials

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:

• Manage contracts and budgets (including change orders) with sites, CROs and vendors.
• Negotiate contracts to optimize costs and timelines, in coordination with legal and finance to pre-agreed terms/parameters.
• Vendor relationship liaison for the Clinical Development Operations organization.
• Exceptional relationship management skills and strong financial acumen.
• Experience drafting and negotiating contracts such as master service agreements, statements of work, confidentiality agreements, supply agreements, consulting agreements, clinical trial and related agreements, and other corporate pharmaceutical-related agreements is required.
• Knowledge of contract law and effective communication, negotiation, and the ability to influence and work collaboratively at all levels and across functions.
• Must have experience with clinical trial agreements, confidentiality agreements and informed consent agreements.
• Proven ability to manage multiple projects, set priorities and meet deadlines.
• Excellent skill level in MS Office including Word, Excel, and Outlook.
• 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.
• Ability to work effectively on a team in an entrepreneurial environment with proven ability to forge cross-functional working relationships with internal/external teams including legal, finance, procurement, sites, and vendors
• 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.

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 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