Company:  Confidential

Job Title: Manager/Senior Manager, Clinical Scientist

Job Number: 23990

Location: Waltham, MA 02451

Job Description


  • Works closely with Medical Directors, Pharmacology, Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols
  • Assists Medical Directors in creation of proposed concept sheets for clinical studies and may write protocols or work with medical writing to write protocols through incorporation of input from both internal and external experts 
  • Drives the clinical contribution to annual update of IB liaising with Toxicology, Pharmacology, Safety, Regulatory and Medical & Communication Experts
  • Drives and integrates clinical contribution to answering regulatory queries and other submissions related to studies
  • Monitors real time study data to ensure the integrity of the study and the study data and interacts with investigators and internal and external experts to resolve any study issues as they arise
  • Involved in high level data cleaning activities requiring clinical judgment
  • Involved in analysis of complex data for regulatory submissions, publications and design of studies and programs 
  • Acts as clinical/scientific expert on the products and studies in the therapy area
  • Attends scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators, and advisors
  • Works with investigative sites to answer protocol related questions, resolve study conduct and design issues
  • May present data, protocol designs and other information at advisory boards, investigator meetings, site initiations and other internal and external settings 

Required Skills

  • MS in Life Sciences (or BS plus equivalent experience); Pharm D, or BSN or other equivalent clinical qualifications 
  • 3-7 years’ experience in product & clinical development (Clinical Scientist role) in Biotech or Pharmaceutical company.
  • Understanding of GCP, ICH and regional/local regulations
  • Experience in both early and late phase development
  • Medical knowledge and experience in clinical development/ operations (Oncology preferred)
  • Experience reviewing clinical data outputs
  • Ability to perform literature searches and to utilize library services
  • Ability to conduct basic data analyses using Excel and other tools
  • Basic understanding of biostatistics to allow effective interaction with biostatistics expert
  • Requires approximately 15-30% travel 

Preferred Qualifications:

  • Teaching capability
  • Excellent communication skills, both verbal and in writing
  • Strong presentation skills
  • 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
  • Experience building data presentation plans


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