Clinical Research Scientist

Summary:

The Clinical Research Scientist provides clinical support to Clinical Development/Medical Teams for clinical/medical issues that impact the full clinical development spectrum for the assigned product. The job will include involvement in the design of clinical development materials (plans, protocols, investigator brochures, etc) as well as assisting the Medical Lead in clinical trial conduct, including data review (data queries, evaluating data integrity and assist in safety data surveillance), and site, vendor or investigator interactions for ongoing clinical trials. The position will work seamlessly with Clinical Operations, Pharmacovigilance, Data Management, Biometrics and Regulatory Affairs as well as other groups within the organization (Commercial, Business Development) to assist the Clinical Development/Clinical Affairs Team and ensure the appropriate dispersal of information within the company and, as necessary, with external advisors. It requires an understanding of the therapeutic context of the clinical program and to be able to be an integral part relevant discussions with sites, investigators, and vendors.

Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

* Manage the clinical development function to ensure that clinical research activities are conceived, planned, and implemented in a timely manner to achieve corporate goals.
* Assist with the preparation and upkeep of appropriate documents, including protocols, amendments, investigator's brochures, SOPs, case report forms, clinical aspects of regulatory submissions, literature reviews, scientific papers, and presentations.
* Assist in all relevant clinical aspects of study design, with appropriate support as needed.
* Partner with Clinical Operations in trial set up, conduct, recruitment activities, closeout, and reporting
* Will play a crucial part in ensuring the accuracy, integrity and completeness of clinical trial data. Identify and resolve discrepancies or errors in clinical trial data and assist Data Management with the review of clinical data and query resolution.
* Ensure compliance with regulatory requirements and company standards, contribute to the development and implementation of data review processes and procedures, collaborate with cross-functional teams to ensure timely and accurate data review
* Assist with medical monitoring and reporting in partnership with Study Responsible Physician, assist in evaluating clinical trial adverse events, review clinical laboratory results, draft adverse event narratives.
* Assist in the safety review of all products including those in the experimental phase of development and in the post marketing phase. Assist in providing scientific input to all relevant documents as necessary throughout the product development life cycle
* Build relationships with clinical investigators, medical/scientific experts in partnership with Study Responsible Physician
* Assist company representatives at steering committee, academic, medical industry and regulatory meetings.
* Embrace a teaching role in investigator meetings and in-house education as appropriate.
* Assists in medical literature reviews and related activities
* Assist in the execution of clinical studies to meet objectives of the study and Clinical Development Program
* Work closely with Quality Management & Assurance to ensure flawless execution of clinical trials in partnership with Study Responsible Physician
* 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.

Supervisory Responsibilities:
This position typically does not have supervisory responsibility.

Interaction:
The position works most closely with the Sr Medical Director but may also interact with clinical operations staff, pharmacovigilance staff, regulatory staff, and CROs to assure the timely and effective medical oversight of clinical studies

Education and Experience:
* Educational scientific background such as MD, PharmD, PhD, Nursing degree, MS
* Minimum of 10 years clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
* Minimum of 5 years of pharmaceutical clinical/medical data/safety review experience

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:
* Experience in designing and conducting clinical trials, including medical data review
* Knowledge of all aspects of the drug development process.
* Working 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.
* Willingness to travel up to 30%

This position 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 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. Will need to lift and move boxes of paper and binders weighing up to 20 pounds.

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 is a remote position and will require on-site presence at clinical trial sites when feasible, as well as travel to for internal/team meetings.

• 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.