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:
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 multiple clinical trials. This position reports to the Senior Director Clinical Operations.
- Responsible for managing and executing clinical studies. Develop and manage study timelines (including recruitment) and may develop and manage program timelines.
- 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.
- Responsible for ensuring clinical study data is generated, documented and reported in compliance with regulations and study plans.
- 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).
- 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.
- Responsible for staff management including training, teambuilding, and mentoring.
- 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.
- Responsible for investigational product inventory, tracking, and reconciliation including distribution to and return from approved distribution centers and investigational sites.
- Oversee the activities of local CRAs/CROs or perform monitoring activities.
- 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).
- Proactively identifies project risks and resolves with some supervision.
- Participates in study data review and other review activities as assigned.
- 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.
- 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.
- Identifies and provides solutions to clinical trial issues and/or risks.
- Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team when designated.
- Works with CRO and Regulatory in filing of applications and responding to deficiencies
- Participate in the clinical department SOP review and development.
- 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 8-10 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
- Prior experience managing direct reports is desirable
- 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 15% 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