Job Description
As a Clinical Development Director, you will be responsible for the scientific and clinical strategy of assigned clinical trials. You will provide clinical leadership, medical and scientific strategic input, and contribute to development of trial-related documents.
You will also develop materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings. Additionally, you will provide clinical and scientific input and contribute to clinical sections of trial and program-level regulatory documents.
* Ensure clinical support of trials as needed;
* Conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s);
* Manage patient safety reports on trial data to safety and clinical boards;
* Provide input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations;
Key Responsibilities
* Contribute to peer-review of Integrated Development Plans (IDPs), Clinical Trial Protocols (CTPs), and other clinical documents across various indications and programs;
* Support Therapeutic Area Head (TAH) in contributing to TA strategies as needed;
* May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities;
* Contribute to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support;
Requirements:
Advanced degree in life sciences/healthcare is required. 5+ years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 2 or more years of contribution to and accomplishment in all aspects of conducting clinical trials.
What You'll Bring To The Role:
Proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level. Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
Benefits:
Competitive salary and benefits package. Opportunity to work with a talented team of professionals. Flexible working arrangements.