Senior/Principle Clinical Scientist

Job description

·  Job facts

Primary Responsibilities and Accountabilities

·  Key-person in RICS to connect to clinical and development project teams in pRED Neuroscience and Rare Diseases (NRD)
·  Develops plans to implement clinical trials in NRD at sites in China in line with the global project strategy
·  Connects external hospitals and physicians with global and local clinical teams
·  In collaboration with the global clinical team supports development and writing of protocol and related documents, e.g. case report form (CRF), informed consent form(ICF), source document verification plan (SDV)
·  Key-contributor to response to questions from regulatory agency/institutional review boards (IRB) in China
·  Participates in development of the China clinical development (CD) plan for assigned molecule(s)/indication(s) and/or other programs:
·  Gathers and analyzes data and information necessary to create the CD plan (particularly in China)
·  Works with other global project team members and relevant sub-teams to develop China CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
·  Works with global project teams and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the China CD plan
·  Assists in the management of China studies and supports the training and science input to clinical operation colleagues and study site staff
·  Serves as trouble-shooter and internal key contact on clinical and medical issues and aspects of assigned studies in China; May support clinical operations, clinical research organizations (CROs), etc. by acting as a point-of-contact for questions, other communications, and interactions in China
·  Provides clinical scientific input for final study reports and annual report documentation
·  Supports safety representatives in the serious adverse events reporting process
·  Represents China clinical science in study management and clinical teams
·  Gives input to and reviews clinical regulatory documents (clinical study reports, investigator's brochure, safety reports, submission to health authorities)
·  Assists in preparing materials for use in internal and external presentations (e.g. advisory board meetings)
·  Supports global project team in preparing for HA meetings. As appropriate, participates in local HA meetings.
·  Able to ethically, effectively and professionally represent the interests of Roche and patients
·  Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs) and other guidelines; Ensure GCP compliance in assigned pharma research and early development studies
·  Possible extension of contribution to other therapeutic areas beyond NRD

Qualifications and experience

·  PhD-/MD-/PharmD-level (or equivalent relevant experience)
·  Clinical research experience in neurological, neuropsychiatric, or rare diseases is strongly preferred
·  >2 years of experience in clinical research
·  Ability to acquire knowledge in different diseases and therapeutic areas
·  Ability to work independently
·  Leadership skills, including motivating, delegating, coaching, and mentoring
·  Personnel managerial skills
·  Demonstrates and applies independent thought in projects
·  Effective scientific communicator
·  Recognized externally in own field
·  A great team player with good communication skills
·  Fluent in English
·  Ability to travel nationally, regionally, and/or internationally (<30%)

Roche is an equal opportunity employer.
Research & Development, Research & Development > Clinical Operations

·  Who we are

At Roche, 98,000 people across 100 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.

Roche is an equal opportunity employer.