Clinical & Regulatory Specialist

Pattern Bioscience; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

Join a leading company in tackling antibiotic resistance as a Clinical and Regulatory Affairs Specialist. This role involves collaboration across R&D, Clinical Affairs, and Regulatory teams, focusing on FDA interactions and clinical trials. You will leverage your microbiology expertise to support research and regulatory submissions, contributing to impactful health solutions.

Benefits

Medical, Dental and Vision Insurance

Personalized PTO

Career development

Library of educational materials

Qualifications

• Possess microbiology domain expertise.
• Experience guiding operational aspects of clinical studies.
• Strong attention to detail and communication skills.

Responsibilities

• Serve as a liaison between R&D, clinical affairs, quality, regulatory, and microbiology.
• Write protocols and study reports for internal and external studies.
• Prepare responses to inquiries from regulatory agencies.

Skills

Microbiology

Data Analysis

Communication

Job description

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Job Title: Clinical and Regulatory Affairs Specialist

At Pattern Bioscience, we’re tackling antibiotic resistance, named by the CDC as one of the biggest public health challenges of our time. We use AI and single-cell analysis to quickly recognize the bacteria causing an infection and to predict which drugs will cure the infection.

Our team is brought together by shared passion for our mission to improve the world’s most important health decisions. However, we’re not only invested in combating antibiotic resistance; we’re also invested in our people.

We are seeking an entrepreneurial Clinical and Regulatory Affairs Specialist. In this role, you will serve at the interface of the R&D, Clinical Affairs, Regulatory, Quality, and Microbiology teams. You will participate in research collaborations internally and with external partners, FDA interactions, and clinical trials.

How You Will Contribute

• Serve as a liaison between R&D, clinical affairs, quality, regulatory, and microbiology
• Write protocols and study reports for internal and external studies
• Conduct literature reviews and summaries to inform and support regulatory strategy, FDA communications, and FDA submissions
• Review and summarize regulatory requirements related to execution of clinical studies
• Support external collaborations with clinical trial partners, study sites, and pharmaceutical partners including contributing to scientific publications and posters
• Prepare responses to inquiries from regulatory agencies
• Contribute to drafting protocol-specific manuals, plans, and documents
• Assist in grant writing and fundraising efforts as needed
• Write progress report summaries required for external grants
• Contribute to the development and implementation of strategies for the earliest possible approval of regulatory submissions

We'd Love to Hear from You If You

• Possess microbiology domain expertise—knowledge of microbes, culture conditions, microbiology instrumentation, antimicrobials, antimicrobial susceptibility testing
• Are skilled at and enjoy analyzing data and summarizing results in a way that translates to people outside of your domain
• Follow as well as lead and give clear written and verbal directions with a high level of accuracy
• Enjoy being self-directed and independent
• Comfortably manage conflict and ambiguity, leading others to understand and accept values, strategies, goals, and plans in response to changing business conditions
• Excel in planning and organizing yourself and groups of people, with strong attention to detail and communication skills
• Have experience guiding the design operational aspects of clinical studies

Goals

30-Day

• Review all FDA communications/interactions to date.
• Work with the VP, R&D, to perform an assessment of outstanding topics requiring FDA feedback, prioritize, and design a schedule for follow-up
• Review existing Clinical Affairs SOPs and protocols, assess gaps, and work with the VP, R&D, to prioritize and design a schedule for follow-up
• Inform product and strategy decision-making as a Clinical and Regulatory Affairs subject matter expert

60-Day

• Participate in an FDA sprint interaction and/or pre-submission interaction
• In collaboration with R&D, write protocols for analytical studies
• Create validation plan for the clinical trial electronic data capture system
• Participate in data monitoring for biobanking protocols
• Design clinical trial data monitoring plan

90-Day

• In collaboration with R&D, finalize study reports for analytical studies
• Work with clinical affairs team to develop worksheets, templates, and build electronic data capture system for Pneumonia clinical trial
• Contribute to contracting and IRB process for clinical trial sites
• Perform site qualification visits for the Pneumonia clinical trial

Details

Location: Remote, 25% Travel

Type of Position: Salaried, Exempt

Department: Clinical Affairs

Benefits

• Medical, Dental and Vision Insurance
• Personalized PTO
• Career development
• The opportunity to make a global impact and pioneer solutions
• Library of educational materials

Check out our Careers page to see all our benefits and what it’s like working with us: https://pattern.bio/join-us/

We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Industries: Food and Beverage Services, Manufacturing, and Food and Beverage Manufacturing

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