Job Title: Senior Medical Director / Vice President
Job Number: 22704
Location: Lexington, MA
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
- 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.