Medical Director/Senior Medical Director, Immunology Clinical Development

Responsibilities 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. Supports early clinical development in immunology B cell program. Manages the design and implementation of study protocols for a clinical development program, ensuring compliance with regulatory requirements and alignment with the overall Product Development Plan. Provides education to investigators, study site personnel, and AbbVie study staff regarding project-related procedures. Oversees clinical studies, monitors overall study integrity, reviews, interprets, and communicates accumulating data regarding safety and efficacy of the molecule. Works with Clinical Operations to oversee study enrollment and overall timelines for key deliverables. Assesses and reports serious adverse events per corporate policy and regulations for assigned protocols. Contributes to the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other program documents. May serve on a Clinical Strategy Team as the clinical representative for the protocols for which the incumbent has responsibility. Develops a rigorous, cross-functionally aligned, vetted Clinical Development Plan in collaboration with matrix team members. Participates in opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial, and other functions as required, consistent with corporate policies. Stays abreast of professional information and technology through conferences, medical literature, and other available training to augment expertise in the therapeutic area. Understands regulatory requirements related to clinical studies and global drug development, and ensures compliance; may contribute to regulatory responses and discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and all other quality standards in conducting research. Medical Director Qualifications Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of an M.D. degree with a relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred; completion of a subspecialty fellowship desirable. Experience in B cell clinical research highly welcome. Ability to run a clinical research study with appropriate supervision. Strong desire to collaborate in a cross-functional setting. Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred. Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in the design of study protocols desirable. Ability to interact externally and internally to support global scientific and business strategy. Must possess excellent oral and written English communication skills. Senior Medical Director Qualifications Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of an M.D. degree with a relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred; completion of a subspecialty fellowship desirable. At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent. Experience in B cell clinical research highly welcome. Ability to run a clinical research program of moderate complexity with minimal supervision. Ability to perform and bring out the best in others on a cross-functional global team. Ability to interact externally and internally to support a global scientific and business strategy. Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols. Must possess excellent oral and written English communication skills. Benefits Competitive base pay range based on job grade; may vary with additional factors and can be modified in the future. Comprehensive benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees. Eligible to participate in long-term incentive programs. Equal Opportunity Statement AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled. US & Puerto Rico only – to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, visit #J-18808-Ljbffr Allergan