Executive Medical Director, Immunology

AbbVie in Mettawa, IL

position filled
Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver and interpret high-quality clinical data supporting overall product scientific and business strategy.

Key Responsibilities Include:
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. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
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) and/or other cross-functional teams and internal stakeholders.
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.



Basic:
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.
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.

You may be interested in these similar jobs!
Receptionist
Dworkin and Maciariello in Chicago, IL

Team D & M, The Illinois Hammer,  is looking for a high energy player to work in a fast paced, team oriented office, focused on co…

Read More
Associate Director Global Multi Channel Marketing Immunology (Glendale Heights)
AbbVie in Glendale Heights, IL

The Global MCM Immunology role will require active engagement with Customer Excellence (MCM team, Marketing analytics, Marketing Excellence, Launch E…

Read More
Associate Director Global Multi Channel Marketing Immunology
AbbVie in North Chicago, IL

Associate Director Global Multi Channel Marketing Immunology **USA, Illinois, Lake County** **New** Marketing Requisition #2001428 …

Read More
Standards of Care Marketing Director (Streamwood)
AbbVie in Streamwood, IL

This person will play a leading role in coordinating cross-functional Immunology Standards of Care initiatives across Rheumatology, Dermatology and G…

Read More
Director of Community Development
Village of Villa Park in Villa Park, IL

Villa Park, Illinois (pop. 22,038), a western suburb of Chicago with direct access to downtown Chicago, is seeking candidates for the position of Dir…

Read More
Executive Director
Sunrise Senior Living in Wilmette, IL

Overview"Sunrise is the best place that I've ever worked, simply because of the people. We provide quality care in an environment that feels like hom…

Read More
Senior Corporate Development Analyst- Paylocity
Paylocity in Schaumburg, IL

Reporting to the Director of Corporate Development, the Senior Corporate Development Analyst will develop and execute strategic efforts around M&A;, …

Read More
Account Executive
Advantage Solutions in Chicago, IL

Account Executive IN Connected Marketing, a division of Advantage Solutions, is a full-service marketing agency that specializes in Shopper Marketing…

Read More
Director of Study and ISR Operations
mix talent in Chicago, IL

Purpose & Scope:Operational leadership in the execution of MA-sponsored studies and Investigator Sponsored Research (ISR). Leads and implements the a…

Read More
CEO _ Commission Free Discount Broker
Discount Brokerage in Chicago, IL

We are a Chicago-based investment research company. We are creating a brokerage firm to offer its affiliated users commission free trading and lookin…

Read More
Director, R&D Communications (Carol Stream)
AbbVie in Carol Stream, IL

The Director of R&D; Communications is responsible for the oversight and management of strategic planning and execution of external communications an…

Read More