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Job Title: Senior Medical Director / Vice President

Job Number: 22704

Location: Lexington, MA

Job Description

We are seeking an experienced Senior Medical Director/VP with extensive drug development experience to join the Clinical Development group and support clinical trials in Cystic Fibrosis and other lung diseases. The successful candidate will b combine a broad knowledge of pulmonology with hands-on experience in drug development The Sr Med Director/VP will work closely and collaboratively with other senior and functional leaders to ensure fully harmonized and integrated development strategies. He/she will maintain a blend of strategic and operational accountabilities and will serve as a TranslateBio spokesperson in external interactions with health authorities, at scientific meetings and with collaborator.


  • Develop and manage Clinical Development Plans, lead the design, development and implementation of high-quality clinical trials for novel drug candidates, from First-in-Human studies through Proof-of-Concept and beyond.
  • Apply state-of-the-art expertise in pulmonology to the selection of pharmacodynamic endpoints, biomarkers, patient selection criteria in order to optimize trial design
  • Maintain the highest quality clinical programs, following GCP and ICH guidelines. Work closely with the CROs, the Clinical Science and Clinical Operations group to maintain a high standard of oversight and familiarity with the data of ongoing trials.
  • Manage timely reporting to regulatory authorities, the production of Clinical Study Reports, publications and presentations
  • Maintain accountability for timelines and deliverables
  • Collaborate closely with other stakeholders inside the company, such as Regulatory Affairs, CMC, Business Development
  • Provide strategic consultation and guidance to Research for decisions with clinical implications or components
  • Provide thorough reviews of documents such as protocol, Investigator’s Brochure, Informed Consent
  • Must be comfortable with outward-facing tasks such as interaction with key opinion leaders, initiating and conducting Scientific Advisory Boards

Required Skills

  • MD with 5+ years of industry experience
  • Experience in lung diseases required, experience with nebulized investigational drugs is a plus
  • Proven track record of successful drug development
  • Broad experience of supporting regulatory interactions (IND, CTA, end-of-phase 2 meeting, NDA, BLA…)
  • Stellar interpersonal, communication and presentation skills, must be able to communicate effectively both in person and in writing
  • Ability and willingness to “roll up their sleeves” and move from detailed work to strategic thinking and back
  • Ability to perform to a high level of quality under rigorous timelines
  • Ability to be both a significant individual contributor and a leader in a multidisciplinary environment

Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.


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