Sr. Director of Clinical Development - Cambridge, MA
Working with the VP, Clinical Development, the Sr. Director of Clinical Development is responsible for contribution to the development of, and implementation of the global clinical strategy and tactical plans in defined program(s).
- Develop expertise to become an emerging leader and content expert in relevant indication(s). In particular Fibrotic diseases.
- Contribute to IND submissions including protocol for FTIH studies
- Learn from the medical and patient communities to inform and execute development plans
- 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 VP, Clinical Development to represent the pharmaceutical company at global medical and advisory meetings, conferences and advisory boards
- An MD or MD PhD with 3-5 years of experience in Clinical Development
- Ideally has early development experience
- Ideally has experience in fibrotic diseases
- 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
- 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
If you or a Director of Clinical Development you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.
Sthree US is acting as an Employment Agency in relation to this vacancy.