Director of Clinical Development
Location
Rockville, MD | United States
Job description
Title: Director of Clinical Development
Location: Must be local Rockville, MD
Type: Perm
Start Date: ASAP
Leading Oncology Pharmaceutical Company located in MD is hiring a Director of Clinical Development with 5+ years industry experience. If you want to be a part of this groundbreaking work, please apply!
The Director of Clinical Development drives clinical development strategy, design, execution, and interpretation of clinical trials.
Clinical Development Expertise & Strategy • Provides oversight and medical accountability for a group of studies. Participates in review of clinical study reports (CSRs)
• Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists
• Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
• Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
• Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Keeps up-to-date in the disease area by attending scientific conferences and ongoing review of the literature
• Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
• Provides ongoing medical education in partnership with CS to allow for protocol-specific training, supporting the study team, investigators, and others
Medical Monitoring • Conducts medical data review of trial data, including eligibility review
• Holds responsibility for site interactions in partnership with the Clinical Scientist (CS) for medical questions and education (including safety management guidelines)
• Holds responsibility for assessment of key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees safety narratives
• Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
Must haves: - MD from accredited institution of Medical Education (board certified preferred; board eligible or OUS equivalent), with oncology and autoimmune diseases background.
- Minimum of 5-8 years of oncology experience for a biologic product
- Strong technical writing skills, ability to write protocols, amend protocols
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