About the job
As a Scientific Director in Oncology Clinical Development, you will play a pivotal role in steering the direction, planning, execution, and interpretation of clinical trials or research activities within our clinical development program. Collaborating with cross-functional teams, you will contribute to the generation, delivery, and interpretation of high-quality clinical data that underpins our comprehensive product scientific and business strategy.
Key Responsibilities:
- Under appropriate supervision, manage the design and implementation of study protocols for a clinical development program, ensuring alignment with the overarching Product Development Plan. Your work will be grounded in robust medical and scientific principles while adhering to compliance and regulatory requirements, and addressing the needs of AbbVie’s customers and markets.
- Take responsibility for reviewing, interpreting, and communicating accumulating data related to the safety and efficacy of our molecules. You will work closely with Clinical Operations to oversee study enrollment and ensure adherence to critical timelines for deliverables.
- Contribute to the design, analysis, interpretation, and reporting of scientific content across various documents such as protocols, Investigator Brochures, Clinical Study Reports, and regulatory submissions.
- Collaborate in the development of a comprehensive, cross-functionally aligned Clinical Development Plan alongside matrix team members.
- Engage with opinion leaders in relevant disease areas and partner with Medical Affairs, Commercial, and other functions as needed, in line with corporate policies.
- Stay informed on professional advancements and technologies through conferences and medical literature, enhancing your expertise in the therapeutic area.
- Understand the regulatory requirements concerning clinical studies and global drug development, ensuring compliance and contributing to discussions and regulatory responses as required.
- Uphold adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and all other quality standards in the conduct of research.