Senior Immunology Clinical Development Director
BioSpace
About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience, and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow AbbVie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description 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. With appropriate supervision, manage the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on strong medical and scientific principles and knowledge of compliance and regulatory requirements. Oversee project‑related education of investigators, study site personnel and AbbVie study staff. Have responsibility for oversight of clinical studies, monitoring overall study integrity and reviewing, interpreting and communicating accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, oversee study enrollment and overall timelines for key deliverables. Report serious adverse events per corporate policy and regulations for assigned protocols. Contribute to 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 under responsibility. Contribute to the development of a rigorous, cross‑functionally‑aligned, vetted Clinical Development Plan in collaboration with matrix team members. Participate in opinion‑leader interactions related to the disease area(s); partner with Medical Affairs, Commercial and other functions as required. Stay abreast of professional information and technology through conferences, medical literature and other training to augment expertise in the therapeutic area. Understand regulatory requirements related to the clinical studies and global drug development and ensure compliance; may contribute to regulatory responses and discussions. Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs and all other quality standards in conducting research. Qualifications Medical Director Qualifications M.D., D.O. or non‑US equivalent with 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 very 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. Ability to interact externally and internally to support global scientific and business strategy. Excellent oral and written English communication skills. Senior Medical Director Qualifications M.D., D.O. or non‑US equivalent with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred; subspecialty fellowship desirable. At least 2 years of clinical trial experience in the pharmaceutical industry, academia or equivalent. Experience in B‑cell clinical research very 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 the development of clinical strategy and design of study protocols. Excellent oral and written English communication skills. Additional Information The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long‑term incentive programs. 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, click here to learn more: #J-18808-Ljbffr BioSpace
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