Job Description About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines
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: immunology,
oncology, neuroscience, eye care, virology, women’s health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com . Follow @abbvie on Twitter ,
Facebook , Instagram , YouTube and LinkedIn .
Purpose Leads the direction, planning, execution and
interpretation of clinical trials or research activities of one or
more clinical development programs. Participates in and may lead
cross-functional teams to generate, deliver and disseminate
high-quality clinical data supporting overall product scientific
and business strategy Responsibilities include: Leads and
demonstrates ownership of the design and implementation of multiple
clinical development programs (or one large, complex program) in
support of the 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.
Responsibility may extend from early translational development
activities to mature product lifecycle management strategies for
internal and/or partnered programs.
Has overall responsibility for leading clinical study teams,
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 ensuring agreed-upon 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.
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.
May serve on or chair Clinical Strategy Team(s), 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 Asset
Development Teams (ADTs) and ADT Leadership Boards (ALBs) and/or
other cross-functional teams and internal stakeholders.
Serves as an in-house clinical expert for one or more molecules
and diseases in the therapeutic area, coordinating and leading
appropriate scientific and medical activities with internal
stakeholders as they relate to ongoing projects. May participate in
or lead clinical development contributions to 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.
Acts as clinical lead and actively solicits 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, 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. 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
At least 5 years (7 years preferred) of clinical trial
experience in the pharmaceutical industry, academia, or
Ability to run a complex clinical research program
Proven leadership skills and ability to bring out the best in
others on a cross-functional global team. Must be able to lead
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
Must possess excellent oral and written English communication
Ability to exercise judgment and address complex problems and
create solutions for one or more projects.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2
consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse
backgrounds to develop new and innovative solutions for patients.
As an equal opportunity employer we do not discriminate on the
basis of race, color, religion, national origin, age, sex
(including pregnancy), physical or mental disability, medical
condition, genetic information gender identity or expression,
sexual orientation, marital status, protected veteran status, or
any other legally protected characteristic.
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