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.
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
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
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.