- Conducts research to develop methodologies, instrumentation methods, and procedures for new drug and medical device products for skin antisepsis, nasal decolonization, and device disinfection.
- Prepares and growth promotes media, performs serial dilutions, incubates, reads and interprets plate count results
- Executes various microbiological methodologies using aseptic techniques to maintain a sterile laboratory environment
- Uses selective media, gram staining, and microscopic examination for microbial identification
- Preparations, inoculations and maintains bacterial, fungal, and mold cultures
- Prepares and authors protocols and amendments, investigator brochures, and other relevant deliverables related to scientific perspectives of clinical studies
- Assists in the design and conduct of complex pre-clinical and clinical research studies requiring the determination and evaluation of microbiological and patient-application methods
- Supports the development of the clinical strategy for regulatory approvals and expanded indications and claims of drugs and medical devices
- Follows strict safety procedures when handling materials to avoid microbiological contamination.
- Manages CRO during clinical studies and serves as a resource to address any questions or clarify issues arising during the conduct of the study
- Monitors investigative sites and activities to verify the protocol is being followed and study activities are being performed correctly by sites
- Evaluates innovative trial designs in collaboration with the study physician
- Prepares scientific publications and conference abstracts/presentations for effective clinical evidence dissemination within the microbiological field
- Conducts systematic literature reviews to support stand-alone projects, protocols, clinical evaluation reports, or other evidence-based summary of clinical literature
- Builds and maintains optimal relationships and effective collaborations with various internal (e.g., cross-functional team) and external parties (e.g., key opinion leaders, academia)
- Maintains a pulse on Industry direction with respect to new claims
- Works with marketing to understand the current clinical landscape and future implications for relevant indications/ patient populations to help drive strategy
- Represents PDI in industry groups and technical committee meetings
- Demonstrate year on year increase in productivity and improvement in competencies.
- Demonstrate research skills to create new test methods/territories in support of PDI's growth targets.
- Ability to work in partnership with the product development and regulatory functions without supervision.
- Establishment of Clinical expertise among the R&D community and business as a whole.
- Ensure implementation of robust processes and procedures that maintain compliance to all applicable GxP regulations, Company and Department procedures/policies.
- Scientific Degree in Microbiology or related field, Masters or higher preferred.
- Regulated background in either FDA (preferred) or EPA environment.
- Working knowledge of the FDA and key international regulations (e.g. ICH) for clinical studies
- Antimicrobial susceptibility testing
- Microbiology technical knowledge
- 3-5+ years of R&D or clinical research experience
- Experience in interactions with outside vendors, e.g., CROs and other third-party laboratories
- Direct experience with IND clinical study design and regulatory submission
- Demonstrated microbiological lab skills
- Excellent communication skills (verbal / written / presentation)
- Highly motivated to work as a member of a nimble team. Embraces change and risk and exhibits flexibility
- Exhibits excellent organization, planning and multi-tasking skills; able to handle multiple projects/tasks at the same time
- Able to influence cross-functional partners to gain support and alignment to ideas
- Steadfast under pressure
- Computer literate (MS 365, Electronic Notebook, LIMS, CTMS, eTMF)
- About 50% Microbiology Lab and 50% office environment
- Domestic and international travel may be required (approximately 10-20%)
- Medical, behavioral & prescription drug coverage
- Health Savings Account (HSA)
- Dental
- Vision
- 401(k) savings plan with company match and profit sharing
- Basic and supplemental Life and AD&D insurance
- Flexible Spending Accounts (FSAs)
- Short & long-term disability
- Employee Assistance Program (EAP)
- Health Advocacy Program
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Clinical Scientist II - Woodcliff Lake, United States - PDI
Description
POSITION PURPOSE
PDI is seeking a Clinical Scientist II - Microbiology to conduct antimicrobial testing, method development, and develop the strategy, design, execution, and interpretation of clinical trials in support of early drug development.
Primarily, the role supports new market launches with input across all facets of project progression including scientific insights, prototype assessment, and registration testing to meet regulatory requirements.
In addition, this role will be developing studies that enhance PDI's current portfolio to provide a competitive edge in the healthcare and food service marketplace to help in the fight against healthcare acquired infections (HAIs) and community acquired infections (CAIs).
The Clinical Scientist II - Microbiology is an experienced laboratory research individual who has demonstrated skill conducting research involving the understanding of microorganisms (bacteria, viruses, and/or fungi) and the impact upon human health.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
PERFORMANCE MEASUREMENTS
REQUIRED KNOWLEDGE
EXPERIENCE REQUIRED
WORKING CONDITIONS
SALARY RANGE
* $70,000 - $100,000
BENEFITS
PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:
PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.
At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.
