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| Senior Clinical Scientist CNS |
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The Senior Clinical Scientist (SCS) assists the Clinical Science Leader (CSL) in all areas of project and study planning, evaluation, documentation including IND and annual report, clinical NDA preparation and protocol preparation. Responsible for a significant part of a clinical program, such as an indication (in all aspects). Typically accountable for more than one protocol.
Primary Responsibilities and Accountabilities:
Contribute in the timely medically and scientifically sound development of the clinical portions of an integrated development plan (IDP).
Liaise with appropriate departments inside and outside PDC to define the timing of discussion with the FDA and other regulatory bodies on format of clinical NDA and submission issues, contribute to the preparation of the appropriate documents and may participate in meetings with regulators on behalf of the CSL.
Contribute with the quality and timely preparation of all PDC documents submitted for approval.
Ensures GCP, Clinical Operating Guidelines and Standard Operating Procedures are followed within PDC.
Assures the consistency of labeling and package insert (clinical section) with database.
Ensures correct data interpretation including interim and Final Study Reports before they are approved.
Assumes protocol authorship, selects the efficacy parameters, defines the range of laboratory marked abnormality values and acceptable laboratory reference values.
Assumes the development and writing of protocols.
Assists with task priorities and schedules within a project as well as time schedule in view of the next assessment point for PDC relevant sections.
Selects, in liaison with other departments, suitable clinical consultants when required.
Represents PDC at monitoring workshops when required.
Contributes to Project Specific Manual for clinical sections.
Assures that the SOPs for evaluation, documentation and reporting of SAEs are strictly followed within PDC and assesses the etiology/causality of SAEs and laboratory abnormalities.
Liaises and communicates with Marketing and co-ordinates clinical efforts on the project related issues.
Contributes in the preparation of abstracts, posters, oral communication for scientific meetings.
Contributes to the career development plans of his/her collaborators and actively ensures that they receive appropriate management and technical support and training. Contributes to orientation and training for employees and signals further educational or training requirements.
Selects, interviews and makes hiring recommendations in reporting area.
Coaches, mentors, develops and conducts performance appraisals of subordinates. |
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Medical degree
Doctorate
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7 years + |
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German : Speak Well
English : Speak / Write Fluently
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open-ended |
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unspecified |
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International |
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Basel |
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MD, PhD, PharmD, Pharm.MS or equivalent qualification with clinical experience in Neurology or Psychatry.
Ability to broaden one's knowledge base and to get 'up to speed' on a new indication within six months
Ability to evaluate, interpret & synthesize scientific data
Ability to verbally present and critically discuss clinical trial data in internal and external meetings
Excellent verbal & written communication skills in English
Experience in working on a clinical team (or equivalent) and a strong team player
Experienced in working in a diverse environment
International perspective
Proven managerial skills - can accurately assess strengths & develop needs of employees, provides challenging assignments & opportunities for development
Must be able to interact within PDC to accomplish goals while providing needed coaching, support or disciplinary action at appropriate times
Familiar with competitive activity in field
Understanding of Roche Business Practices (strategic and product marketing, and sales).
Ability to understand the relationship between high business potential, medical need and development cost and timelines
Understanding of FDA and ICH guidelines, global regulatory agency requirements
Experience in publishing results of a clinical drug trial in a refereed journal
Experience in writing a global clinical development plan or clinical study protocol
Ability to motivate peers and bring out the best in people
Ability to educate and mentor, and serve as a resource for other functions.
Apply online at http://careers.roche.com
Who to contact: Contact HR: M. Steininger, Phone: +41 61 68 74894 |
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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. |
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