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Senior Clinical Research Scientist

Who we are:
EMD Serono is the North American biopharma brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the brand has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas.

 

Your role:

The Senior Clinical Research Scientist represents and may lead Neurology clinical activities on the assigned clinical study within global clinical development. Interacts with multi-disciplinary, matrix work group ensuring that scientific and as appropriate issues are appropriately considered with respect to highly complex data findings and escalated to Medical Directors as needed. This individual has significant impact on the creation, maintenance, and execution of a clinical development plan for drugs in neurology and multiple sclerosis, including Evobrutinib.

 

Who you are:

  • Manage assigned activities within clinical study independently, including monitoring activities
  • Develops clinical development plans providing clinical/scientific input and gathering necessary information from other areas
  • Participates in the design and scientific rationale for clinical trial protocols, including most recent literature citations
  • Liaises with discovery, external experts, external partners to accumulate scientific and medical knowledge necessary to support clinical development plan
  • Drives creation and annual update of IB liaising with Toxicology, Pharmacology, Safety, Regulatory and Medical & Communication Experts
  • Communicates and trains clinical development team members, as well as other teams (i.e clinical operations, etc) in new scientific directions within the multiple sclerosis program
  • Works with the multiple sclerosis Clinical Operation Team (COT) and Medical Communications Group to ensure the publication plans for the MS drugs program are in line with the strategic messages
  • Assists Medical Directors in creation of proposed concept sheets for clinical studies
  • 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
  • Assists medical directors with scientific sections (modules) of marketing authorization applications, writing complete study reports, safety evaluations
  • Attends scientific meetings to remain abreast of new developments within the multiple sclerosis program
  • Bachelor’s degree in Life Sciences, required
  • Fluency in English
  • Excellent medical knowledge and experience in clinical development/ operations in neuroimmunology, neuroscience or neurobiology
  • Performance in multiple functions and multiple business sectors/group functions
  • Lead role in functional or operational strategies
  • Ability to interact with international colleagues
  • Experience in product & clinical development (at least 5 years in an industrial or comparable setting)

Preferred:

  • Graduate degree (Masters in Science or PhD)
Job Requisition ID:  202585
Location:  Billerica
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

US Disclosure
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, transgender status, marital status, 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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Nearest Major Market: Boston

Job Segment: Research Scientist, Toxicology, Clinic, Neurology, Immunology, Science, Healthcare

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