Clinical Science Leader - Oncology

Who we are

At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.

The headquarters in Basel is one of Roche’s largest sites. It is home to the Corporate Executive Committee, the Pharmaceuticals and Diagnostics Divisions and the global business functions. Roche Basel also covers the entire business chain from research, development and production through to marketing. Over 8,000 people from more than 60 countries work at the site.

The Position

We are looking for a Clinical Science Leader for Avastin hematology who will assume the medical science leadership in all areas of project including the clinical component of the Clinical Development Plan (CDP), Study Protocols, data evaluation, and clinical NDA preparation. The successful candidate will ensure that all documents are developed with sound, valid clinical judgment.They will also represent the department in the Life Cycle Team (LCT) as core member.  Principal functional responsibilities: 

• Ensure the timely development of the clinical component of the Clinical Development Plan (CDP) 
• Responsible for the timely preparation and quality of relevant PDM documents 
• Contributes, through the LCT, to appropriate budget and manpower planning 
• Assure GCP, Clinical Operating Guidelines and Standard Operating Procedures are carefully followed 
• Represent the department in the International Project Team 
• Represent the clinical interface for scientific/medical related issues with Regulatory Authorities 
• Represent the main interface in this department with Clinical Operations for project related activities
• Assume the development and writing of protocols 
• Assign task priorities and schedules within a project
• Select suitable clinical consultants
• Plan and perform on an ongoing basis an evaluation of project related clinical data 
• Ensure correct data interpretation including interim and Final Study Reports (FSR) 
• For Final Study Reports (FSR) not written by a Clinical Documentation Specialist, decides on FSR authorship 
• Decide on task delegations to, and is accountable for, his/her collaborators according to their individual capabilities 
• Liaise and communicate with strategic

  Marketing and Key Countries on project related issues 

• Co-ordinate preparation of abstracts, posters, and papers for scientific meetings/publication plans 
• Contribute to the career development plans of his/her collaborators and actively ensure that they receive appropriate management, technical support and training 
• Select, interview and make hiring recommendations in reporting area 
• Manage investigator IND studies and/or studies conducted by government collaborative study groups 
• Assist the Group Leader in TAST related activities including licensing, and may assume TAST membership 
• Provide clinical expertise, and interact frequently with research project teams 

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

To be successful in this role you will have/be:

• MD and/or Ph.D. or equivalent qualification and good scientific/development competence within the Oncology area
• Several years experience in clinical research, some portion of which having been spent in the pharmaceutical industry 
• Proven managerial skills, an international perspective and proven ability to interact well in a team setting 
• Excellent communication skills and be fluent in the English language
• The ability to travel frequently

The next step is yours. To apply today, click on the "Apply online" button below.