Senior Scientific Director, Oncology Clinical Development (Hematology)

Responsibilities

• Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues.
• Oversees project-related education of investigators, study site personnel and AbbVie study staff.
• Makes decisions regarding the design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and other program documents.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications

• Bachelor's degree in the sciences; advanced degree (e.g., MS, PhD) preferred. Hematology experience preferred.
• At least 8 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Ability to run a complex clinical research program independently.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
• Excellent oral and written English communication skills.
• Ability to exercise judgment and address complex problems and create solutions for one or more projects.