-Support early clinical development in immunology B cell program.
-Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
-May serve on a Clinical Strategy Team as the clinical representative for the protocols for which the incumbent has responsibility. Contributes to the development of 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 in these activities 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.
-Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions.
-Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
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Medical Director Qualifications:
-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 is 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 M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is 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 development of clinical strategy and the design of study protocols.
-Must possess excellent oral and written English communication skills.
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Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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 thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many fa
Benefits
Vision insurance
Additional Information
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.
Abbvie · North Chicago, IL