Job Title: Clinical Development Scientist, Neurology

Location: Cambridge, MA

About the Job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

The Clinical Research Director (CRD) is noted as the primary clinical expert for programs. The role requires a well-organized, strategic and operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.

• Work with development physicians for the preparation of supportive documents for AdBoards and meetings with Regulatory Affairs
  
• Literature review update related to external opportunities
  
• Participates to the review of the list of countries for clinical studies and ensures alignment with Medical Affairs and Commercial teams on the business case for each country
  
• Compiles regulatory, launch and reimbursement status in collaboration with regulatory, commercial and market access teams.
  
• Collaboration and interaction with the Project Team members and the Project Leader and with the other departments of the Neurology TA (clinical pharmacology, Global Safety Officer, biostatistics, regulatory, Medical affairs and commercial teams) to facilitate the preparation of deliverables that need various contribution.
  
• Contribute to the preparation of clinical sections of protocols, key result memo, clinical study reports, regulatory agency update reports, and other clinical and regulatory documents with focus on more routine/standard document elements describing all clinical procedures/ or studies to be included in this respective documents.
  
• Participates to the review of scientific publications and communications to ensure data accuracy with source documentation such as CSR.
  
• Provides support for the preparation of presentations used for different committees (BRAC, TARC, , , GPTM, STF, DWG...)
  
• Participate at Global program level meetings, such as, , GPTM, , STF Requested Profile
  
• Educational background: Scientific medical degree (PhD) with strong experience (>10 years) in Pharma business across different entities (R&D and Medical Affairs)
  
• Experience in KOL interactions, in data review and interpretation, in manuscripts and abstracts preparation
  
• Knowledge of Pharmacovigilance and CMC landscape, of project planning tools
  
• Understanding of clinical research process from program planning to regulatory submission
  

• Ability to drive and coordinate activities including prioritizing capacity, issue identification and resolution
  
• Ability to motivate the team towards advancing the project according to milestones and delivering good quality data
  
• Ability to work, network and communicate with a global product team, in an international matrix organization and across companies in co- development projects
  
• Ability to interact productively with external investigators
  
• Strategic thinking, analytic and synthetic capacity
  
• Team spirit and teamwork ability
  
• Must have good communication (oral and written) skills Language skills
  
• Fluent in English
  
• French or a third language might be advantageous
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.