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.
Manages the design and implementation of one or more clinical development programs in support of an
overall Product Development Plan, based on strong medical and scientific principles, knowledge of
compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging
issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff.
Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review,
interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.
Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for
key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy
and regulations for those protocols on which assigned.
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 Associate Medical and/or Scientific Directors, and of Clinical Scientists working
on the same or related programs.
Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and
medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in
due diligence or other business development activity. As required by program needs, contributes in
partnership with Discovery colleagues to design and implementation of translational strategies.
May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous,
cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and
alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team
members and serving as Clinical Research representative to lend clinical development and medical expertise
to an Asset Development Team (ADT), ADT Leadership Board (ALB).
Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and
disease area; partners with Medical Affairs, Commercial and other functions in these activities as required,
consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into
Clinical Development Plans and protocols as appropriate.
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.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 20 % of the Time
Job Type: Experienced