Senior Director, Clinical Development
Waltham, MA, USA | Radius Health, Inc.
Industry:Pharmaceutical / Biotech
Job Description:65 people have viewed this job
Radius is a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases. We are currently recruiting a Senior Director, Clinical Development who would be part of a team responsible for designing, executing, interpreting and reporting of clinical studies for the investigational drug product Abaloparatide.The Senior Director will be responsible for supporting a broad scope of clinical deliverables to include: monitoring and analyzing the effects of pharmaceutical products or other medical treatments given to patient groups in clinical trials and developing medical protocols and instruments for clinical applications and analysis.
Integrates relevant scientific findings from projects and literature, to facilitate research and overcome scientific challenges.
Design and implement clinical trials, including writing medical protocols, creatively working to assess appropriate endpoints
Interprets data, assess integrity of data and provides scientific summaries.
Works closely with biostatistics team to complete statistical analysis plan.
Works closely with CSO, Research, Clinical and other project team members to achieve scientific goals.
Identify CROs or other collaborations that enable models or apply expertise that is not available in-house.
Provide Life Cycle Management, clinical submission activities, and indication development.
Collaborate with, monitor and report CRO-based study results to the project team.
PhD or MD with at least 10 years of clinical trial experience is preferred; a Bachelors or Masters in a scientific discipline with at least 10 years of directly relevant industry experience is required.
Demonstrated expertise in the design, authoring and successful implementation of clinical protocols and clinical study reports is required.
Strong experience reviewing & interpreting study data/reports and presenting findings to project team members is required.
Incumbent will have excellent organizational, written and oral communications skills.
Project management skills including process improvement methodology such as Lean Sigma/Change Management is preferred.
Demonstrated experience in scientific writing is required.
A deep understanding of therapies in the osteoporosis setting is highly desirable.
Experience in overseeing design, execution and analysis of Phase I-IV studies is a requirement.
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