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Senior Director / Vice President of Clinical Development

Cambridge, MA

Posted: 03/13/2019 Job Category: Clinical: Clinical Operations and Development Job Number: 2243

Working with the CMO and SVP, Clinical Development, the Senior Director / VP of Clinical Development will:
  • contribute to the development of, and implementation of the global clinical strategy and tactical plans in defined program(s)
  • provide support and leadership as appropriate for the safety group

RESPONSIBILITIES:
  • Clinical Development (60%):
  • Develop expertise to become an emerging leader and content expert in relevant indication(s).  In particular Fibrotic diseases
  • Represent clinical at cross functional team filing IND
  • Lead cross functional team to put in place clinical development plan
  • Initial focus on protocol and execution of FTIH study
  • This position involves rigorous scientific interactions with investigators, KOLs, and global regulators.
  • Lead the program ensuring strategic alignment and execution of internal and external priorities and activities.
  • Proactively identify program risks, and create and implement mitigation strategies
  • Accountable for the day-to-day clinical, medical and scientific questions from various internal and external sources
  • Participate in the ongoing interpretation and analysis of clinical trial results including human pharmacokinetics, pharmacodynamics, laboratory and biomarker data, review and approve clinical trial coding, and safety monitoring
  • Collaborate cross-functionally in the preparation briefing books for health authority interactions, clinical protocols, investigator brochures, target product profiles, annual IND reports, severe adverse advent reports, periodic safety update reports, clinical study reports
  • Timely reviews and analysis of the pertinent medical (disease-specific) literature
  • Work with team to prepare and/or deliver abstracts, posters, and slide presentations at external Conference Symposia, and manuscripts for peer-reviewed journals
  • Collaborate with SVP, Clinical Development to represent Company at global medical and advisory meetings, conferences and advisory boards

 
  • Safety (40%):
  • Work with safety group and CRO to ensure that all pharmacovigilance obligations are fulfilled
  • Perform medical review of individual case reports.  Overall responsibility for assessing expectedness and company causality in a timely manner
  • Medical follow-up of clinical trial cases with investigators for missing/clarification of safety information
  • Review Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans in conjunction with clinical development teams and CROs
  • Maintain up-to-date knowledge of global HA/ethics expedited and periodic submission requirements and train clinical safety team members as necessary

 

REQUIREMENTS / QUALIFICATIONS:
  • An MD or MD PhD with 3-5 years of experience in Safety / Clinical Development
  • Ideally has early development experience
  • Ideally Board Certified (or the equivalent)
  • A leader who is a passionate drug developer driven to help patients
  • Can inspire both internally (cross functional teams) /externally
  • Creative mindset
  • Comfortable with ambiguity
  • Excellent interpersonal and negotiation skills
  • Strong verbal and written communications and presentation skills
  • Ability and willingness to travel up to 20% of the time

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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