Translate Bio

Job Title: Senior Medical Director / Vice President

Job Number: 22704

Location: Lexington, Massachusetts

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.

Responsibilities

  • 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.

 

Apply for job

To apply for this job please visit k7y.pl.