Summary:
The purpose of this position is to provide medical support 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 Medical Monitoring and site 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 ensure the appropriate dispersal of information within the company and, as necessary, with external advisors. The position will also be responsible for assisting 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 site staff.
Responsibilities
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.
* Participate in the preparation and upkeep of appropriate documents, including protocols, amendments, investigator's brochures, SOPs, case report forms, clinical aspects of IND and NDA/MAA submissions, literature reviews, scientific papers, and presentations.
* Assist in all medical aspects of study design, with appropriate support as needed.
* Act as Medical Monitor of clinical studies and support site initiation, on-site presentations, site close-out and adverse event evaluation and reporting.
* Assist in the execution of clinical studies to meet objectives of the study and Clinical Development Program
* 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.
* Assist in coordinating early development and preclinical IND enabling activities both within the company and through external vendors and CROs.
* Assist company representatives at steering committee, academic, medical industry and regulatory meetings.
* Embrace a teaching role in investigator meetings and in-house education.
* Participate in the formulation of overall clinical strategy.
* Assist in providing scientific input to in-licensing product opportunities and provide rationale, timing, and budgeting information to formulate eventual decision to license.
* Assist in the safety review of all products including those in the experimental phase of development and in the post marketing phase.
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.
Qualifications
Education and Experience:
* MD or DO or equivalent from an accredited college or university.
* PhD and/or medical subspecialty certification a plus.
* At least 2 years of clinical practice experience is preferred.
* At least 1-2 years clinical research experience in the U.S. biotech/pharmaceutical industry and/or in academic environment. CRO experience will be considered.
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.
* Experience in designing and conducting clinical trials, including medical monitoring
* 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.
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. This position requires considerable hospital presence and requires the ability to walk and stand for periods of time.
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.
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
EEO Statement
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.
