Medical Director/Senior Medical Director, Immunology Clinical Development

With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.

Responsibilities:
- Support early clinical development in immunology B cell program.
- Manage design and implementation of study protocols (with appropriate supervision) aligned to the Product Development Plan; oversee education of investigators, study site personnel, and AbbVie study staff.
- Oversee clinical studies: monitor study integrity; review/interpret/communicate accumulating safety and efficacy data; oversee enrollment and key deliverable timelines (with Clinical Operations); assess/report serious adverse events per policy and regulations.
- Contribute to design, analysis, interpretation, and reporting of scientific content (protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other documents).
- Serve as clinical representative on a Clinical Strategy Team; contribute to development of a vetted, cross-functionally-aligned Clinical Development Plan.
- Participate in opinion leader interactions and partner with Medical Affairs/Commercial and other functions as required.
- Stay abreast of professional information and technology.
- Understand and comply with regulatory requirements for global drug development; may contribute to regulatory responses.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards.

Medical Director Qualifications:
- MD/DO or non-US equivalent; relevant specialty; residency strongly preferred; fellowship desirable; B cell clinical research experience very welcome.
- Ability to run a clinical research study with appropriate supervision.
- Cross-functional collaboration desire; clinical trial experience preferred.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; protocol design desirable.
- Ability to interact externally/internally to support global scientific/business strategy.
- Excellent oral and written English communication.

Senior Medical Director Qualifications:
- MD/DO or non-US equivalent; relevant specialty; residency strongly preferred; fellowship desirable.
- 2+ years clinical trial experience; B cell clinical research experience very welcome.
- Ability to run a moderate-complexity clinical research program with minimal supervision.
- Ability to lead on cross-functional global teams.
- Knowledge of clinical trial methodology; regulatory/compliance requirements; clinical strategy and protocol design experience.
- Excellent oral and written English communication.