Senior Director, Operations & Clinical Strategy

San Francisco, California | Full-Time

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The Senior Director is accountable for the resourcing, development, training and management of a successful Clinical Operations, Biostatistics, Programming and Data Management team. The candidate will have demonstrable track record of leading and overseeing clinical research programs. The candidate will be a strong relationship manager, a strategic thinker, and have an entrepreneurial mindset and ability to work with agility.

 

ROLE‌ ‌AND‌ ‌RESPONSIBILITIES: ‌ 

  • Provide leadership, strategic oversight, and guidance of Clinical Operations to ensure quality, timeline, resources and budget goals are met
  • Establish performance indicators and apply to ensure the successful execution of clinical trials to agreed timelines  
  • Ensure the effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans and study protocols at Juul; interact and collaborate with other department heads as appropriate
  • Lead & mentor Clinical research staff to support successful internal training and its implementation and serve as an advocate for professional development of Clinical Operations staff
  • Oversee, plan and implement Quality Checks for clinical projects and provide leadership and direction to ensure the highest standards for compliance with Company SOPs, ICH-GCP guidelines, Regulatory authority regulations and patient safety standards 
  • Mentor clinical operations staff on the Regulatory Inspections process and develop a pro-active approach for Inspection readiness 
  • Assist the QA department in the development, review and updating of Juul clinical SOPs 
  • Accountable for the authorship of operational sections of protocols and investigator brochures, and leading the identification of and interaction with investigative sites and investigators, including study execution.  
  • Develop and manage CROs, external experts and Investigators to ensure effective execution of internal and external clinical projects.  
  • Coordinate with the VP of Scientific Affairs and broader Regulatory Science organization and to deliver high quality data deliverables on time and on budget (e.g. collaboration with statisticians, collaboration with data managers, data overview, clinical study reports, etc.) 
  • Provide support for regulatory submissions, supporting dossier development and participating in interactions with FDA, EMA and other regulatory agencies
  • Keep abreast of competitive regulatory and clinical practices and utilize this knowledge during the ongoing development and adjustment of plans.

 

PERSONAL‌ ‌AND‌ ‌PROFESSIONAL‌ ‌QUALIFICATIONS: ‌ ‌

  • 10+ years experience in clinical research and operations
  • Nicotine research experience preferred
  • Education/Experience: regulatory, and safety documents preferred
  • Experience with clinical data management and pharmacovigilance is a plus
  • In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection
  • Experience in developing protocols, SOPs, Clinical Study Reports as well as other clinical processes, and change to management and staff 
  • Experience leading a rapidly changing environment and integrating new personnel is essential, as well as ability to evaluate and resolve complex problems 
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods. Self-motivated to maintain expertise in regulatory requirements and guidance to ensure that the Clinical Operations remains compliant with GCP and other global regulatory guidelines or laws 
  • For the best fit, you should be a results-oriented team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues

 

EDUCATION: 

The ideal candidate will have: 

  • Bachelors in Life Sciences, Nursing Licensure or Pharmacy
  • An advanced degree (MS, PhD, PharmD or MD or MBA) preferred but not required 

 

TECHNICAL, MANAGEMENT & LEADERSHIP COMPETENCIES

  • Development and strategic planning of clinical research projects
  • Ability to operate with a strong business mindset and make effective decisions, or decision recommendations to senior executives
  • In-depth understanding and experience across the clinical operations value chain- study planning, execution, data cleaning, database locking, study report generation and regulatory inspection, audits, report writing, publishing of clinical trial data.
  • Experience with global drug development and NDA filing is preferred; experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred
  • Results-oriented team player with strong interpersonal and communications skills, capable of working collaboratively with cross-functional colleagues
  • Demonstrated ability to effectively manage projects and people. Proactive problem-solving and focus on outcomes 
  • Ability to influence without authority and manage cross-functional teams in matrix organizations
  • Strong communication and presentation skills-demonstrates strong written and verbal communication skills and ability to relay vision/strong sense of department organization, processes, and change to management and staff 
  • Experience adapting and leading through change with ability to evaluate and resolve complex problems

 

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, Inc.
Juul Labs, Inc.
HQ: San Francisco, California

Juul Labs is a thriving team of scientists, engineers, designers and professionals who are committed to offering adult smokers alternatives to combustible cigarettes, while combating underage use of our products. JUUL products are designed to transition adult smokers from combustible cigarettes by providing a competitive nicotine experience.

Company size: 1500

  • Salary
  • Career Level
  • Degree
  • Experience
  • Job Type
  • Attractive
  • Executive
  • Degree Preferred
  • 10+ Years
  • Full-Time
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