Medical Director, Clinical Development and Strategy
2 days ago
We are seeking a highly skilled and experienced Medical Director to lead our Clinical Development and Strategy team at AbbVie. As a key member of our organization, you will be responsible for overseeing the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs.
Key Responsibilities- Program Development: Manage the design and implementation of one or more clinical development programs in support of an 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.
- Project Oversight: Oversee project-related education of investigators, study site personnel, and AbbVie study staff.
- Study Integrity: Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
- Regulatory Compliance: Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
- Scientific Content: Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
- Team Leadership: May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs.
- Strategic Partnerships: Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity.
- Clinical Strategy: May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
- Regulatory Representation: Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
- Professional Development:
- Regulatory Expertise: Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.
- Regulatory Compliance: Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
- Quality Assurance: Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
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