Clinical Research Scientist, Immunology / NDD
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POST DATE 8/13/2016
END DATE 12/20/2016
JOB DESCRIPTIONEMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.
Clinical Research Scientist, Immunology (BTK inhibitor program)
The Clinical Research Scientist represents, supports, and may lead immunology clinical development activities on the assigned clinical studies within global clinical development. Works closely with medical directors, and interacts with multi-disciplinary, matrix work group ensuring that scientific planning, execution, and analysis of clinical studies and clinical development plans is completed with high quality.
* Manage assigned activities within clinical program independently
* Assists Medical Directors in creation of proposed concept sheets for clinical studies, supporting Regulatory documents, clinical trial reports, and other trial and program-related documents
* Communicates and trains clinical development team members, as well as other teams (i.e. clinical operations, etc.) in new scientific directions within the BTK inhibitor program
* Works with BTK inhibitor Clinical Operation Team (COT) and Medical Communications Group to ensure the publication plans for the BTK inhibitor program are in line with the strategic messages.
* Works closely with Medical Communications to ensure all relevant documentation is updated with new medical information, including assuming responsibility for the incorporation of new information into the Investigator Brochure
* Acts as clinical/scientific expert on the products in the therapy area
* Attends scientific meetings to remain abreast of new developments relevant to the clinical Immunology programs
* Invites experts to give seminars in the clinical Immunology program field (mechanism of disease, animal models of disease, genomics and pharmacogenomics, current therapies)
CANDIDATE S PROFILE
EDUCATION & LANGUAGES
* Graduate in Life Sciences (Master of Science or equivalent)
* PhD, preferred
* Fluency in written and spoken English is required
* Good medical knowledge and experience in clinical development in all phases with emphasis on Phase II and III clinical studies in Immunology
* At least 3 years of technical/operational experience in planning, executing, reporting and publishing clinical studies.
* Familiarity with pharma/biotech clinical operations and conduct of research collaborations, with a thorough understanding of ICH, GCP, and relevant regulatory requirements.
* Ability to perform literature searches and to utilize library services
* Strong analytical and strategic thinking skills.
* Teaching capability
* Excellent communication skills, both verbal and in writing
* Strong presentation skills
JOB-SPECIFIC COMPETENCIES & SKILLS
* Strong scientific background
* Regional/global Regulatory requirements
* Strong scientific writing skills
* Demonstrated ability to communicate effectively with senior management
* Familiar with creation of slide presentations
* Ability to work in a Matrix Organization environment
* Highly self-motivated and proactive
* Team player
* Ability to proactively predict issues and solve problems
* Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team
* Diplomacy and positive influencing abilities
ADA REQUIREMENTS (mandatory for US employees)
* Normal and routine office duties
* Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
* Requires approximately 10-20 % travel.
Equal Employment Opportunity
The Company is an Equal Employment Opportunity employer.
No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.
This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.
Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.