Senior Clinical Science Manager

Clinical Document Specialist

In collaboration with clinical and project teams of the company, this role provides support for the design, planning and development of clinical narratives or other associated documents in the clinical evaluation research studies in oncology with a focus on solid tumors. This position also provides support in the preparation and authoring of clinical development related documents in particular clinical narratives and contribute in other documents including SOPs, Work Process Documents, study synopses and protocols. Responsibilities also include summarizing study results for the preparation of documents such as narratives, and publications, supporting project teams with process flow documents providing progress updates related to the assigned clinical studies.

Essential Duties And Responsibilities:

Collaborate with the clinical teams for a specific product candidate including the design, preparation and initiation of clinical narrative sand other trail related documents and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.

Conduct appropriate literature research for the assigned clinical product candidate.

Work with the medical monitor to enable interaction with clinical sites and thought leaders in oncology to assist sites in efficient completion of clinical narratives among other documents to support clinical trials.

Maintain clinical and technical writing expertise in the therapeutic area of Oncology; review scientific journals, attend scientific and key technical meetings as warranted.

Collaborate with team members in clinical review and interpretation of study data in support for preparation of reports for health authorities including regulatory filing documentation and study close-out reports.

Prepare clinical patient based narratives as necessary to support Clinical Study Reports

Assist in the writing and/or review of product specific abstracts, publications, and supports the development of presentations for scientific meetings.

Proactively provide feedback on emerging clinical and competitive trends.

Deliver high quality scientific presentations on Exelixis investigational agents to physicians and other key external customers.

Supervisory Responsibilities:

N/A

Education/Experience:

BS/BA in related field and a minimum of 9 years of related experience; or,

MS/MA in related field and a minimum of 7 years of related experience; or,

PharmD/PhDand a minimum of 2 years of related experience; or,

Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

Two to five years of clinical development experience in the biotechnology or pharmaceutical industry or a combination of academia and industry.

Experience in public presentation required and education program development preferred.

Knowledge/Skills:

General knowledge of clinical trial implementation and drug development process.

Identifies and implements methods and procedures to achieve results with high quality.

Performs a variety of complicated tasks with a wide degree of creativity and latitude.

Has understanding and wide application of technical principles, theories, concepts and techniques.

Applies strong analytical and business communication skills.

Past experience in preparation of clinical or safety based Clinical Narratives

Highly organized and able to work under tight timelines

Good public speaking and presentation skills

Good Technical Writing skills

Job Complexity:

Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.

Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.

Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.

Networks with key contacts outside own area of expertise.

Working Conditions:

10-25% travel requirement.