Executive Director, Clinical Development Operations
Description
- 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
- This position will supervise a Clinical Development Operations Team.
- 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
- 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
- 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
EEO 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.