Primary responsibility for and ownership of 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 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. May represent AbbVie at key external meetings.
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 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
Ability to run a complex clinical research program independently.
Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
Ability to interact externally and internally to support a global scientific and business strategy.
Extensive 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.
Ability to exercise judgment and address complex problems and create solutions for one or more projects.
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
Benefits
Vision insurance
Additional Information
Purpose:
Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs, with principal responsibility for clinical strategy including the end-to-end Clinical Development Plan(s). Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.
Abbvie · San Francisco, CA