THE COMPANY:

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.

JOB DESCRIPTION: 

This position is accountable for clinical operational activities and executing all associated  operations from start to finish, consistent with applicable regulations, guidelines, and policies.  This position should be able to independently manage clinical trials. This position reports to the  Senior Director Clinical Operations.  

Roles and Responsibilities 

  1. Responsible for managing and executing clinical studies. Develop and manage study  timelines (including recruitment) and may develop and manage program timelines. 2. Ensure all trials are conducted in compliance with the study protocol, Good Clinical  Practice (GCP), Good Laboratory Practice (GLP), the Declaration of Helsinki, and all  applicable regulatory requirements. 
  2. Responsible for ensuring clinical study data is generated, documented and reported in  compliance with regulations and study plans. 
  3. Participates in the selection of CRO/ investigational sites. Manages CRO activities,  including project timelines & quality of deliverables, and managing approved trial  budget(s) throughout the life of the assigned clinical trial(s).  
  4. Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed. Provide or facilitate training to CRO on assigned protocol specific  topics. 
  5. Responsible for clinical site activities which include site selection, regulatory submission, site start-up, enrollment and close-out. Working directly with local CRO/CRA and/or site (coordinator/PI(s)) to ensure timelines and compliance in alignment with overall clinical  objectives. 
  6. Responsible for investigational product inventory, tracking, and reconciliation including distribution to and return from approved distribution centers and investigational sites. 8. Oversee the activities of local CRAs/CROs or perform monitoring activities. 9. Contributes to development and finalization of study documentation including clinical  protocols, informed consent forms, case report forms, clinical study reports as well as  operational plans (monitoring plan, project management plan, communication plan). 10. Proactively identifies project risks and resolves with some supervision. 11. Participates in study data review and other review activities as assigned. 12. Oversees clinical trial sites’ adherence to pertinent regulations through review of  monitoring reports, CQA-GCP audit report, communications with investigators, study  site personnel, CRAs, and other CRO/designee personnel. 
  7. Oversees the submission of trial-related and essential documents to the Trial Master File,  Investigator Site Files and patient records (at site and Sponsor) per company SOPs and in compliance with GCP, FDA and ICH guidelines.
  8. Identifies and provides solutions to clinical trial issues and/or risks. 
  9. Represents Clinical Operations in cross-functional initiatives, as assigned by  management, and may act on behalf of team when designated. 
  10. Works with CRO and Regulatory in filing of applications and responding to deficiencies 17. Participate in the clinical department SOP review and development.
  11. Interact with cross-functional team to accomplish above responsibilities

Personal and Professional Qualification and Education 

  • Bachelor’s or Master’s degree in relevant scientific discipline with at least 6 years of  clinical operations experience relevant industry experience at a CRO and/or  pharmaceutical/biotech organization. 
  • Thorough understanding of FDA, ICH and GCP guidelines 
  • Experience with Phase I – III clinical trials 
  • Proven track record showing clear proficiency in clinical project management skills • Proven complex problem-solving skills 
  • Solid vendor management skills, e.g. CRO, Laboratory & Clinical supply logistics • Broad understanding of clinical operations related to clinical development functions • Ability to effectively interface with medical personnel at clinical site(s) • Ability to lead multi-disciplinary, cross-functional teams both internally & externally • Excellent interpersonal, verbal and written communication skills  
  • Proficiency with computer programs including Microsoft Office suite and Microsoft  Project 
  • Ability and willingness to travel 10% of the time 

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
  • Boundless snacks and drinks
  • Cell phone subsidy, commuter benefits and discounts on JUUL products
  • Excellent medical, dental and vision benefits
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 authorization to work for Juul Labs in the US.

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