Job Description

About AbbVie
AbbVies 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 peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens 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 for Phase 1 studies at AbbVie Clinical Pharmacology Research Init (ACPRU). 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:

* Leads and demonstrates ownership of the design and implementation of multiple clinical development programs with respect to Phase 1 and clinical pharmacology studies 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.
* Principal investigator or sub-investigator for all Phase 1 and clinical pharmacology studies conducted at the ACPRU with oversight of all clinical study activities. Responsible for clinical decision-making including eligibility assessment, adverse event adjudication, medical management of enrolled subjects, completion of safety follow-up, and review of safety data (including pharmacokinetics). Case report form (CRF) review and approval. Review, edit, and act as primary signatory for clinical study reports (CSR's) for all studies at ACPRU and selected studies performed at other sites. Responsible for interacting with central IRB members, concerning protocols, informed consents, and associated documents.
* Has overall responsibility for leading Phase 1 study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with ACPRU 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 Phase 1 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 clinical pharmacology programs.
* Serves as an in-house clinical expert for one or more molecules and study volunteers, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical 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 molecule and study volunteers; partners with Development, 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 clinical pharmacology and the therapeutic areas of interest to AbbVie. 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. May serve as a clinical pharmacology representative for key regulatory discussions related to clinical pharmacology studies.
* Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications
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. Illinois medical license required.
* 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.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
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.