817 million, that's how many lives our products touched in 2018. While we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
The Associate Clinical Development Director (Assoc. CDD) is responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. May be responsible for the clinical and scientific strategy of assigned sections of a clinical development program, depending on the size and complexity
Responsibilities (but not limited to):
Provides clinical leadership, medical and scientific strategic input, and contributes to development of trial related documents.
Provides clinical and scientific input and contributes 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:
Ensures clinical support of trials as needed
Conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
Manages patient safety reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT)
Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations
Supports Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs
Supports development of TA strategies, as needed
May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities.
Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required.
PharmD, or PhD strongly preferred
Development experience in an academic or industry environment spanning clinical activities in Phases I through IV
2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
Demonstrated ability to establish effective working relationship with key investigators
Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes