Roche

Senior Clinical Director

Company
Roche
Location
Welwyn
Salary
Competitive
Posted
04 Jun 2021
Closes
04 Jul 2021
Ref
202102-103850
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
At Roche, we are passionate about transforming patients' lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

Collaborative innovation is at the very heart of the organisation and we invest more than most other companies in R&D to drive this. We have a truly differentiated portfolio across oncology, inflammation, immunology, infectious diseases, ophthalmology and neurology which covers a uniquely broad spectrum of innovative solutions for healthcare needs of the future. Projects address all stages of prevention, diagnosis and treatment of disease as well as enhancing the quality of life.  

We are proud of our history bringing patients first-in-class and best-in-class products, and we continue to develop products that have breakthrough designations for high unmet needs. Roche has a long track record in bringing novel treatments for infectious disease to patients and has been at the forefront of developing therapeutics and diagnostics for SARS-CoV-2 and as a result we are recruiting for an experienced physician. 

We are looking for a like-minded individual to take on the role of Clinical Science Leader for AT-527 working closely with the Global Development Leader to ensure the design and delivery of the Clinical Development Plan. The AT-527 program is about to enter phase 3. Therefore this is a great opportunity to take a leading role in the program as it approaches key milestones, as well as the opportunity to influence and guide development of additional indications.

You will be a mentor and leader for the clinical science team, which is 3-4 physicians and scientists. Bringing a wealth of experience, you will inspire and motivate your teams and peers whilst ensuring they have the opportunity to develop and strengthen their own skills and experience.

With strong ideas, and the ability to move these forward into tangible actions, you will be an innovative leader who can influence across functions and geographies. To be successful in this role you will need to quickly build credibility and work well with key senior stakeholders at our development partner company.   

To find out more about what it's like to work in our Immunology, Inflammation and Ophthalmology Clinical Science team in Welwyn, watch this video .

Who you are:

  • M.D. with relevant medical and/or development experience ideally in an aspect of infectious disease, however experience in critical care or pulmonology would also be considered 
  • Experience with clinical trials across Phase II - III drug development within the pharma / biotech industry

    Experience leading a filing team and/or making a significant contribution to key filing documents such as integrated summary document, clinical overviews etc. Experience of label language and post-marketing commitment negotiations a distinct advantage
  • Experience in assessment of unmet need and using this to inform the design and justification for clinical development plans
  • Some experience in the evaluation of external opportunities, due diligence activities etc would be an advantage
  • Some experience of working in a co-development situation with a partner company also advantageous
  • Has working knowledge of the multi-disciplinary functions involved in a company's drug development process, e.g. clinical operations, biostatistics, regulatory, commercial operations, etc.  
  • Experience working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.) 
  • Experience developing product and safety profiles 
  • Versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations
  • Academic/teaching background is a plus
  • Has impeccable ethics.  Demonstrates, or proven abilities to demonstrate, Roche Values  
  • Good interpersonal, verbal communication and influencing skills; can influence without authority 
  • Strong written communication skills 
  • Good business presentation skills; is comfortable and effective when presenting to others, internally or externally 
  • Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally 
  • Good judgment and decision-making skills; knows how to make trade-off decisions while balancing ethics and efficacy 
  • Works well within teams and is effective in collaborating with others internally and externally 
  • Ability to travel globally (


Good luck with your application.

Similar jobs

Similar jobs