Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
May oversee the work of Medical Directors and/or Scientific Directors, and of Clinical Scientists working on the same or related programs.
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. Serves as a clinical representative for key regulatory discussions.
Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
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.
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.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
We offer a comprehensive package of benefits including paid time off (vacat
Benefits
Vision insurance
Additional Information
Purpose:
Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.
Abbvie · San Francisco, CA