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Title:  Regulatory Science Clinical Director

Job ID:  72622
Country:  Switzerland
City:  Geneve
Professional area:  Scientific Regulatory Affairs
Contract type:  Permanent
Professional level:  Experienced
Location: 

Geneve, GE, CH, 1202

 

We’re JTI, Japan Tobacco International and we believe in freedom. We think that the possibilities are limitless when you’re free to choose. In fact, we’ve spent the last 20 years innovating, creating new and better products for our consumers to choose from. It’s how we’ve grown to be present in 130 countries.

But our business isn’t just business. Our business is our people. Their talent. Their potential. We believe when they’re free to be themselves, grow, travel and develop, amazing things can happen for our business

That’s why our employees, from around the world, choose to be a part of JTI. It is why 87% of employees feel happy working at JTI. And why we’ve been awarded Global Top Employer status, eight years running

So when you’re ready to choose a career you’ll love, in a company you’ll love, feel free to #JoinTheIdea. 

Learn more: jti.com

 

 

 

Regulatory Science Clinical Director

 

 

What this position is about - Purpose:

Reporting to the VP of Regulatory Science and under their leadership, Regulatory Science Clinical Director is accountable for providing operational and strategic direction for all clinical assessments that will be conducted as part of JTI's Reduced Risk Products Regulatory Science Strategy. She / He will lead the execution of all externally-conducted clinical assessments with accountability for the overarching regulatory scope, testing approach and the development of protocol templates. The person will be accountable for monitoring and cascading best practices for the testing of JTI's Reduced Risk Products across all Regulatory Science clinical initiatives. The individual will review and sign-off the clinical sections of associated regulatory submissions.

 

What will you do - Responsibilities:

  • Working with the Regulatory Science VP to execute clinical Regulatory Science initiatives:
    • Overseeing through our external partners, all aspects of clinical trial execution. This includes but is not limited to site start-up, patient enrollment, monitoring, compliance, budget and data flow metrics from the clinical sites, contracting, study documents
    • Ensuring initial feasibility assessment and early country and site engagement to optimize clinical program delivery
    • Is accountable for evaluating and mitigating issues relevant to clinical studies
    • Is accountable for the sign-off on clinical sections of associated regulatory submission documentation
       
  • Accountable for providing strategic guidance on clinical challenges and future developments impacting Regulatory Science planning processes:
    • Providing strategic input to Regulatory Science clinical operations activities
    • Anticipating and reporting clinical and regulatory industry trends
    • Benchmarking Regulatory Science research activities, leads analysis of the competitive landscape and the regulatory environment and develops future Regulatory Science clinical proposals
  • Influencing and providing awareness to other related internal business functions on the requirements and approach of the Reduced Risk Products Strategy
  • Being a Key interface with functional managers and Program leadership for resource requests or prioritization of activities:
    • Developing and having total oversight of JTI's internal clinical processes, including the development of Standard Operating Processes and policies, study oversight, and training
    • Supporting, motivating and guiding the professional development of new Regulatory Science team members

 

Who are we looking for - Requirements: 

  • Degree (Science) preferably to PhD or professional doctorate (e.g., MD, DVM, PharmD) level
  • 6+ years experience working in a multinational organization in a highly regulated industry (e.g., Tobacco, Pharma, medical devices) is a must
  • Proven ability to develop clinical programs to meet business goals and to assess business risk versus potential value
  • Proven experience of leading delivery through collaboration within globally matrixed teams
  • Experience implementing global multi-site clinical trials and operational practices preferred
  • Experience with PMTA, MRTP and investigational tobacco products applications and evaluating multiple categories within the reduced-risk product space is highly desirable
  • Excellent English communication skills (both written and verbal) are a must
  • Excellent interpersonal and business relationships skills, multi-cultural sensitivity, good negotiation skills
  • Ability to assimilate and communicate scientific business information at different levels across the organization

 

What are the next steps – Recruitment process:

Thank you very much for your interest in the role. You are welcome to apply.

 

 


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