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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.

Clinical Pharmacology Medical Senior Director (Illinois based)

Grayslake, Illinois Req ID 2204727 Category Medical Division AbbVie

Proposed Job Title: Senior Director, Clinical Pharmacology Medical

Purpose:

Describe the primary goals, objectives or functions or outputs of this position.

Leads the direction, planning, execution, and interpretation of clinical trials or research activities of multiple clinical pharmacology programs on site at the AbbVie Clinical Pharmacology Research Unit (ACPRU) in Grayslake IL. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical pharmacology data supporting overall product scientific and business strategy.

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

•Leads and demonstrates ownership of the design and implementation of multiple clinical pharmacology trials 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, subinvestigators and study site personnel.

•Has overall responsibility for leading clinical trial 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, execution, analysis, interpretation, and reporting of scientific content of protocols and Clinical Study reports.

•Oversses the work of Medical and/or Scientific Directors and of Clinical Scientists at ACPRU.

•Serves as an in-house clinical expert/principal investigator for one or more molecules and diseases, 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 clinical pharmacology studies and healthy volunteers, partners with 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 studies. 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.

•Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications:

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

•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 required.  Completion of a subspecialty fellowship is desirable.  Illinois medical license or in process of obtaining Illinois medical license. 

•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 pharmacology 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
ABBVIE

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