Senior Director, Clinical Development Job Description Template
Our company is looking for a Senior Director, Clinical Development to join our team.
Responsibilities:
- Works closely with CSO, Research, Clinical and other project team members to achieve scientific goals;
- Integrates relevant scientific findings from projects and literature, to facilitate research and overcome scientific challenges;
- Interprets data, assess integrity of data and provides scientific summaries;
- Identify CROs or other collaborations that enable models or apply expertise that is not available in-house;
- Design and implement clinical trials, including writing medical protocols, creatively working to assess appropriate endpoints;
- Provide Life Cycle Management, clinical submission activities, and indication development;
- Collaborate with, monitor and report CRO-based study results to the project team;
- Works closely with biostatistics team to complete statistical analysis plan.
Requirements:
- Demonstrated expertise in the design, authoring and successful implementation of clinical protocols and clinical study reports is required;
- A deep understanding of therapies in the osteoporosis setting is highly desirable;
- Strong experience reviewing & interpreting study data/reports and presenting findings to project team members is required;
- Experience in overseeing design, execution and analysis of Phase I-IV studies is a requirement;
- Demonstrated experience in scientific writing is required;
- Project management skills including process improvement methodology such as Lean Sigma/Change Management is preferred;
- Incumbent will have excellent organizational, written and oral communications skills.