JUUL's mission is to improve the lives of the world’s one billion adult smokers by driving innovation to eliminate cigarettes. JUUL is the number one US-based vapor product. Headquartered in San Francisco and backed by leading technology investors including Tiger Global, Fidelity Investments and Tao Invest LLC, JUUL Labs is disrupting one of the world’s largest and oldest industries.
We’re an exceptional team with backgrounds in technology, healthcare, CPG and biotech, and we’re growing rapidly to deliver on our mission. We’re actively looking to hire the world’s best scientists, engineers, designers, product managers, supply chain experts, customer service and business professionals.
ROLE AND RESPONSIBILITIES:
- Serve as the medical expert for assigned clinical trials by providing safety oversight and advise on study-related questions/issues during study conduct
- Provides safety oversight and performs medical monitoring, medical review of safety events and contributes to provide medical review, analysis, and interpretation of data from clinical studies
- Provides input into the design and conduct of clinical trials and interpretation, and support clinical site and internal training
- Responsible for study-related documents e.g., study protocols, safety plans, safety data assessment, clinical study reports, and develops scientific presentations as requested
- Additional tasks may involve attendance and participation at Investigator Meetings, preparation of subject narratives and other documents, preparation and/or review of periodic and interim safety reports
- Reports to Sr. Director of Clinical Affairs and partners with clinical research project leads
- Support the development, execution, and communication of the US scientific/medical evidence study plans
- Support cross-functional collaborations to integrate broad medical, scientific, and commercial input into the development program
- Participate in and provide input into clinical trial design, safety and regulatory interactions
- Function as the medical expert for assigned clinical studies which includes being available to advise on related medical questions/issues during study conduct
- Provide clinical/scientific input during the development and execution of clinical trials
- Take lead role in on-going safety data analysis, interpretation, and reporting
- Take lead role in development and implementation of standard operating procedures for all aspects of safety event report handling, aggregate reporting, and assuring compliance with global and local governing regulatory requirements
- Participate in teleconferences and face-to-face meetings with US/global regulators.
- Participate in CSR, publications, and regulatory submission review
- Make scientific presentation at advisory boards, key meetings and external committees
- Identify new clinical research opportunities
- Support Senior Director of Clinical Affairs, Medical Affairs, and Chief Medical Officer as needed Ensure quality system compliance as it relates to area of responsibility.
- Perform other related duties as required.
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- MD/DO with a minimum of 4 years of US/Global clinical research experience as a clinical research medical monitor involved in the clinical trial development from concept to execution and analysis
- Active US license to practice medicine with no disciplinary history
- Functional understanding of local and global safety regulations and processes and clinical study oversight, including global GCPs
- Demonstrates ownership necessary for achieving or surpassing desired results; recognizes and capitalizes on opportunities with a "See It, Own It, Solve It, Do It" mentality and makes, keeps and answers for personal commitments
- Functional fluency with MeDRA and WHO coding
- Prior experience working with electronic data capture (EDC) systems,
- Excellent interpersonal and communication skills with the ability to interface at all levels including management both internally and externally (encompasses verbal, written, interpersonal, listening)
- Strong attention to detail and time management skills (timelines, schedules, task prioritization)
- Flexible; ability to adapt to changing priorities
- Strong experience presenting to a wide variety of audiences including internal teams and medical/scientific communities
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
- Location. Work in the heart of San Francisco, one of the world’s greatest cities
JUUL Labs is proud to be an equal opportunity employer and is committed to creating a diverse and inclusive work environment for all employees and job applicants, without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We will consider for employment qualified applicants with arrest and conviction records, pursuant to the San Francisco Fair Chance Ordinance. JUUL Labs also complies with the employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have the authorization to work for JUUL Labs in the US.