300 million people worldwide are affected by rare genetic diseases. Since 2013, Novartis Gene Therapies (formerly AveXis) has one focus: bringing change to those devastated by a rare genetic disease which frequently affect the nervous system with chronic, progressive, and degenerative pathology that disproportionately (~ 83%) affects children.
Seeking candidates at the Clinical Development Director and Senior Director levels. Position will be located at East Hanover, New Jersey; Cambridge, Massachusetts; or Libertyville, Illinois
As Clinical Development Director, you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. You may also be responsible for the clinical and scientific strategy of assigned sections of a clinical development program, depending on the size and complexity.
WHAT YOU'LL BE DOING; - Provide clinical leadership and scientific strategic input, and contribute to development of trial related documents, develop materials for trial-related advisory boards, data monitoring committees, investigator meetings, and protocol training meetings for Novartis local medical organizations
- Provide input and contribute to clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities)
- In collaboration with appropriate Clinical Trial Team (CTT) members:
1. Ensure clinical support of trials as needed
2. Conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
3. Manage patient safety reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT) with appropriate oversight from Medical Lead
4. Provide input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations
5. Support Therapeutic Area Head (TAH) with peer-review of IDPs, CTPs, and other clinical documents across various indications and programs
6. Support development of TA strategies, as needed
7. May work on medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities
8. Support talent and career development of CD associates through on-boarding, coaching, and/or mentoring; develop and champion CD culture; and may take part in performance evaluation of CTT members