Executive Director, Clinical Development Operations - Parsippany, United States - Pacira Pharmaceuticals

Description

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:

The Executive Director, Clinical Development Operations, will lead a best-in-class clinical operations group with accountability for the operational delivery of all sponsored clinical trials within the Pacira portfolio.

They will function as the key strategic partner to leadership ensuring that the portfolio is appropriately prioritized, resourced, and delivered according to agreed strategy, timelines, and budget.

They will lead the Clinical Development Operations teams and be held directly accountable by the head of Clinical Development for the operational delivery of the portfolio of studies.

They will inform, influence, and drive decisions through the application of quantitative data-driven operational planning and execution and by active participation at and leadership of major governance meetings.

In partnership and in close collaboration with other leads and functional lines within the clinical team and Development Leadership Team, they will be responsible for leading the identification, development, and implementation of Clinical Development Operations standards processes and industry-leading best practices.

They will set the highest expectations for quality and operational excellence fostering a culture of continuous improvement and inspiring clinical study team leads to execute studies with purpose and deliver against Pacira strategic imperatives.

They will actively engage in talent development and provide the structural and cultural framework for the development of team leaders, realizing the potential and maximizing the impact of the role.

They will safeguard the safety and well-being of trial participants through the provision of high-quality operational oversight and be a point of escalation for operational quality issues arising from sites and the development of associated CAPA's.

Essential Duties & Responsibilities:

• Serves as single point of accountability for the operational delivery of the Pacira portfolio of clinical studies and regulatory submissions consistent with the requirements of the Clinical Development Plans either through external partners (e.g., CRO) or internal delivery models
• Identifies, leads, and implements industry leading best practices for the conduct of clinical trials
• Drives a culture of continuous improvement and a workforce that excels in clinical project management execution
• Sets expectation, secures resources, and holds clinical study team leads accountable for the delivery of clinical studies to the highest quality standard, against agreed timelines, and within assigned budget
• Accountable to ensure that clinical study teams are effectively leading teams through various stages of the clinical studies from start up through submission, as well as overseeing the quality and accuracy of data input for management reporting on study performance
• Ensured risk management and risk mitigation strategies are in place are in place and implemented for all studies in the clinical portfolio
• Ensures that deliverables align with industry leading standards on quality, speed, and cost for clinical plan operationalization
• Holds clinical study teams accountable for ensuring that studies are inspection ready at all times
• Influences and informs clinical development strategy, portfolio, prioritization, and budget allocation through clinical operations input to therapeutic categories
• Inspires, motivates, and engages operations colleagues, providing clarity of purpose and sets expectations of operational excellence, and continuous improvement
• Develops talent management plan and provides infrastructure and support for continued professional development
• Collaborates within the Clinical and Development Leadership teams to develop, prioritize, and support leadership team activities
• Ensures compliance with all applicable regulatory, operational, and technical requirements and adherence to relevant SOPs assigned to roles

Supervisory Responsibilities:

• This position will supervise a Clinical Development Operations Team.

Interaction:
This position collaborates closely with internal colleagues across the clinical organization as well as Biostatistics, Pharmacovigilance, and Regulatory Affairs.


Qualifications:

• Bachelor's degree required, advanced degree or professional certification in a health care related, scientific, or technical discipline preferred
• 15 years of industry experience with oversight of clinical trial operations on the sponsor side in the US biotech/pharmaceutical industry, experience in pain studies preferred
• Proven ability to develop successful collaborations with internal and external partners required
• Minimum of 5 years' experience in a management/leadership role
• Extensive knowledge of clinical development, research regulations, ICH/GCP, and adverse event management
• Demonstrated clinical/medical administrative and project management capabilities, as well as effective verbal and written communication skills in relating to internal and external stakeholders
• Demonstrated experience managing, developing, and training teams in clinical development

Knowledge, Skills, and Abilities:

• Demonstrated working knowledge of cGCP, ICH, and other relevant clinical development regulations and processes
• Demonstrated problem-solving skills with strong business acumen
• Proven ability to manage multiple projects, set priorities and meet deadlines
• Excellent written and verbal English communication skills, including ability to present to groups varying in sizes
• Demonstrated ability to quickly and comprehensively learn about new subject areas and environments and effectively communicate that information

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.

While performing the duties of this job, the employee is regularly required to sit, talk, and travel to congresses and the main office as needed.

When travelling, the employee will be required to 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.

This position is based in our Parsippany NJ office, a typical office environment with offices and cubicles. Occasional travel may be required for leadership meetings.

Equal Opportunity Employer/Veterans/Disabled


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