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Associate Medical Director Oncology Clinical Development Lead
2 months ago
We are seeking a highly skilled and experienced Medical Director to lead our Oncology Clinical Development program at AbbVie. As a key member of our team, you will be responsible for overseeing the direction, planning, execution, and interpretation of clinical trials and research activities.
Key Responsibilities- Manage the design and implementation of study protocols for a clinical development program, ensuring compliance with regulatory requirements and AbbVie's business operations.
- Oversee project-related education of investigators, study site personnel, and AbbVie study staff, extending from early translational development activities to mature product lifecycle management strategies.
- Monitor overall study integrity, review, interpret, and communicate accumulating data pertaining to safety and efficacy of the molecule.
- Assess and report serious adverse events per corporate policy and regulations for assigned protocols.
- Contribute to the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and responses.
- Participate in opinion leader interactions related to the disease area(s) and partner with Medical Affairs, Commercial, and other functions as required.
- Stay abreast of professional information and technology through conferences, medical literature, and other available training to augment expertise in the therapeutic area.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and all other quality standards in conducting research.
- Strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues.
- Ability to lead cross-functional teams and contribute to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan.
- Excellent communication and project management skills, with the ability to interpret and communicate complex scientific data.
- Strong understanding of regulatory requirements related to clinical studies and global drug development.
