Executive Medical/Scientific Director, AbbVie Clinical Pharmacology Research Unit

Purpose:

Manages Clinical Pharmacology Medical Department and Clinical Pharmacology Unit Operations staff on site and leads the direction, planning, execution and interpretation of clinical trials or research activities across several clinical pharmacology programs.  Acts as the overall leader of the Clinical Pharmacology Research Unit in Grayslake IL interfacing across multiple departments.  As a teacher and mentor, trains and guides both individuals and teams to help them execute effectively and achieve excellence in their assigned tasks.

Responsibilities:

•Accountable for reports who lead and have ownership of the design and implementation of multiple clinical pharmacology programs in support of the overall product development plans, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues.  Ensures that staff provides project-related education of investigators, study site personnel and AbbVie study staff.

•Trains and lends expertise to staff who serve as Principal and Sub Investigators and other study staff to ensure high-quality, cross-functionally-aligned clinical pharmacology studies and study deliverables with full consideration of contingencies and alternative approaches.  Ensures that staff have capabilities to monitor overall study integrity, study enrollment and timelines.

•Provides or ensures clarity regarding the appropriate level for review and approval of design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses and other program documents.

•Manages Medical Directors (typically 2 to 4 direct) and Operations Director.  This responsibility involves direct oversight of clinical pharmacology activities and/or management of personnel who may be working on other projects.  Responsible for hiring, onboarding, mentoring, training and supporting career development of these individuals.

•Serves as the in-house clinical pharmacology expert broadly across several molecules and disease areas, directing appropriate scientific activities with internal stakeholders as they relate to ongoing clinical trials.  May lead clinical development contributions to due diligence or other business development activity.  Contributes in partnership with Discovery and Development colleagues to design and implement translational strategies at a disease area and platform level.

•Acts as a senior-level liaison for opinion leader interactions related to clinical pharmacology; partners with Pharmacovigilance, 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 disease area strategies and Clinical Pharmacology Development Plans as appropriate.

•Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area.  Actively seeks opportunities to represent AbbVie at key external meetings and enhance AbbVie’s reputation as an industry leader.

•Responsible for having deep understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.  Serves as a senior clinical pharmacology 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.

Qualifications:

•Advanced degree in science (e.g., MS, PharmD,

PhD) or Medical Degree (MD, DO) required.

•Medical degree with at least 10 years, PhD with at least 15 years , PharmD with at least 18 years or Masters in Science with at least 22 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.  Deep clinical pharmacology expertise strongly preferred.

•Ability to prioritize across and help others effectively lead, several complex clinical research programs.

•Proven leadership skills and ability to bring out the best in others on a cross-functional global team.  Must be able to lead and manage through influence.

•Prior experience as a direct or matrixed manager, with a demonstrated track record of training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy.

•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 across multiple projects.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.