Associate Medical Director/Scientific Director, Clinical Development - Immunology

Role Summary

Associate Medical Director/Scientific Director, Clinical Development - Immunology. Oversees direction, planning, execution and interpretation of clinical trials or research activities within a clinical development program. Collaborates across functions to generate, deliver, and interpret high-quality clinical data supporting product scientific and business strategy.

Responsibilities

• With supervision, design and implement study protocols for a clinical development program in support of the Product Development Plan; oversee education of investigators, study site personnel, and AbbVie study staff.
• Oversee clinical studies, monitor study integrity, and interpret and communicate accumulating data on safety and efficacy; manage study enrollment and timelines for key deliverables; assess and report serious adverse events per corporate policy and regulations.
• Contribute to design, analysis, interpretation, and reporting of scientific content (protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other program documents).
• May serve on an Integrated Evidence Strategy Team; contribute to development of a rigorous, cross-functionally-aligned Clinical Development Plan.
• Engage in opinion leader interactions related to the disease area; partner with Medical Affairs, Commercial and other functions as required, in accordance with corporate policies.
• Stay abreast of professional information and technology through conferences and literature to augment therapeutic-area expertise.
• Ensure understanding of regulatory requirements related to clinical studies and global drug development; contribute to regulatory responses and discussions as needed.
• Adhere to Good Clinical Practices, pharmacovigilance standards, SOPs and other quality standards in research.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent with relevant specialty; rheumatology experience or lupus research preferred.
• Ability to run a clinical research study with supervision; strong collaboration skills in a cross-functional setting.
• Clinical trial experience in pharma, academia, or equivalent preferred; knowledge of trial methodology and regulatory/compliance requirements.
• Ability to interact externally and internally to support global scientific and business strategy.
• Excellent oral and written English communication skills.

Skills

• Clinical development program design and oversight
• Data interpretation and regulatory submission experience
• Cross-functional collaboration and stakeholder management
• Regulatory knowledge related to clinical trials and global drug development
• Good Clinical Practices and pharmacovigilance standards

Education

• Medical degree required (M.D. or D.O.); advanced research experience in rheumatology or lupus is a plus.