Director, Clinical Science

  • Location:Cambridge, MA
  • Department:Clinical
  • Type:Full Time
  • Min. Experience:Senior Manager/Supervisor

 

Covid- 19 Mandatory Vaccination Requirement

Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe.  Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.

 

RESPONSIBILITIES:

  • Contributes to the clinical development strategy and operational plans working as part of an integrated drug development team
  • Contributes to the development of the clinical study design and writing of the study synopsis and protocol
  • Contributes to clinical development plans, clinical sections and review of other study related documentation (Investigator’s Brochure, Scientific Rationales/Justification, Regulatory agency briefing documents and responses to questions, Clinical Study Reports)
  • Works with clinical sites to answer protocol related questions, resolve study conduct and design issues
  • Contributes to the development of and participates in Investigator Meetings, Study Initiation Visits, and Advisory Boards as appropriate
  • Reviews data listings, laboratory data, and vital signs data to establish the presence or absence of abnormal trends, and follows up as appropriate
  • Involved in analysis of data for regulatory submissions, presentations, publications, and study designs
  • Assists in review of all adverse experience reports for accuracy and clinical importance, characterization of severity, seriousness, and relationship to the study drug
  • Works closely with other functions such as safety, biostatistics, data management, and regulatory affairs to provide accurate reports to FDA or other regulatory agencies
  • Presents findings internally and externally (such as investigator meetings), acting as a spokesperson for the company relating to the trial/indication
  • Attends scientific meetings to stay current on new developments within relevant areas
  • Other duties as assigned

 

EDUCATION AND EXPERIENCE: 

  • At least 2 years of oncology drug development experience
  • Advanced degree in biological sciences or health-related field is required (e.g. Ph.D., Pharm. D, M.S.N, M.P.H., PA, NP)
  • Experience operating independently implementing clinical trials
  • Collaborative team player with excellent interpersonal and communication skills
  • Ability to strategically and proactively think and lead in interdisciplinary teams
  • Experience in data analysis and interpretation
  • Experience in immuno-oncology preferred