Clinical Trial Lead
JUUL Labs’ mission is to impact the lives of the world’s one billion adult smokers by eliminating combustible cigarettes. We have the opportunity to address one of the world’s most intractable challenges through a commitment to exceptional quality, research, design, and innovation. Backed by leading technology investors, we are committed to the same excellence when it comes to hiring great talent.
We are a diverse team that is united by this common purpose and we are hiring the world’s best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career at one of the fastest growing companies is compelling, read on for more details.
ROLE AND RESPONSIBILITIES:
The Clinical Trial Lead (CTL) is responsible for the execution of clinical studies from protocol development through final reporting in collaboration with the Medical and Clinical Affairs team. The CTL will be responsible for developing timelines, budgets, vendor selection for clinical studies and leading the execution of these studies according to time, cost and quality targets. The CTL is responsible for proactive operational risk management for clinical studies. In this role, the CTL will regularly interface with key business stakeholders and team members across several functions, including Marketing, Engineering, Product Management, Quality, Regulatory, R&D, Clinical Operations, Clinical, Data Management and Statistics as
well as external physicians, clinicians, research staff, CROs, and other vendors. This role is responsible for coordinating study efforts both within the Company and through a variety of vendors.
- Contribute to the planning, monitoring, and implementation of clinical programs which may be in the early, late, or post-marketing
authorization/vigilance stage of development.
- Responsible for building and maintaining study budgets and timelines
- Works collaboratively with clinical affairs team and key stakeholders.
- Ensures supporting documentation (i.e. case report forms, monitoring plans, data management plans, safety plans, clinical study reports, etc.) support protocol objectives and operational efficiencies.
- Provides study updates to senior clinical management, project stakeholders and to business unit/corporate management.
- Actively tracks study data analysis and publication activities.
- Ensures completion of timely clinical study reports for use by internal and external customers (e.g. core teams, discovery teams, and regulatory submissions).
- Maintains strong relationships with study sites and clinicians. May review reports and support resolution of issues related to external sites as needed in support of clinical study activities.
- Act as mentor to clinical operations team members and has expertise in the
operational delivery of a clinical study.
- Effectively selects and manages Contract Research Organizations (CROs) and other vendors as needed, including drafting request for proposals (RFP), to complete clinical studies.
- Ensures regular review, summary and reporting of accurate clinical study progress to Clinical Affairs team, stakeholders, project teams, regulatory, throughout the course of a study.
- Communicates direction and updates to clinical study team members, assign tasks as appropriate, and ensure that commitments are met.
- Proactively identifies study risks and works to mitigate them or create contingency plans.
- Monitor clinical study teams and provide appropriate operational support for ongoing clinical studies as liaison from JUUL Labs. Confirm that key third party milestones are met, including IRB review, clinical supply preparation, recruitment, and analysis related milestones.
- Collect and assist with evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies.
- Serve as part of a team which liaisons with FDA and other regulatory bodies for clinical review of JUUL related programs.
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- Bachelor of Science Degree in life science or related field
- 6+ years of clinical trial work experience
- In-depth knowledge of project management tools and best practices (e.g., Microsoft Project, SmartSheet, Tableau, EDC and eTMF systems)
- Financial tracking & study budget forecasting
- Excellent written & verbal communication skills
- Ability to collaborate and interact effectively on a cross-functional team
- Experienced in the operational execution of clinical studies, including the management of study files
- Organizational, leadership, risk identification and problem-solving skills
- Experience with combination drug-device products a plus
- Experience with class II/III product approvals, adaptive trial designs, a plus
- CCRA, CCRP, CCPM Certification a plus
KEY ATTRIBUTES NECESSARY FOR SUCCESS:
- Demonstrates a passion for helping improve the quality of life and reduce morbidity and mortality for adult tobacco consumers
- Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals
- Team player, works well in a team environment both as a leader and a key contributor
- Flexibility and ability to work in an unstructured environment
- Experience working at biotech startups
JUUL LABS PERKS & BENEFITS:
- A place to grow your career. We’ll help you set big goals - and exceed them
- People. Work with talented, committed and supportive teammates
- Equity and performance bonuses. Every employee is a stakeholder in our success
- Catered lunch, boundless snacks and drinks
- Cell phone subsidy, commuter benefits and discounts on JUUL products
- Excellent medical, dental and vision benefits
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