Description
We are recruiting for a Clinical Development Director within Oncology Clinical Trials who will lead program level activities. The role is primarily concerned with Data Analytics.Responsibilities:
- Be responsible for leadership and strategic input for clinical deliverables which will include protocols, Development Plans, clinical data review, program specific standards, clinical components of regulatory documents and registration dossiers as well as publications
- Lead development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
- Oversee and conduct medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
- Support overall safety of the molecule for the assigned section, and be a core member of the Safety Management Team (SMT), and support overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
- Provide medical input into IDP and CTP reviews and contribute development of disease clinical standards for new disease areas.
- As a clinical expert, support internal as well as external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
- May work with Translational Medical Sciences to drive transition of pre-PoC projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed
Requirements:
* Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD strongly preferred
* ? 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ? 3-5 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
* Advanced knowledge of Oncology therapeutic area
* Demonstrated ability to establish strong scientific partnership with key stakeholders
* Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process
* People management experience preferred, this may include management in a matrix environment. Global people management experience desirable
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.