Posted in: Executive Management in Chicago | Posted: |
Job Description
Accountable for reports who lead and have ownership of the design and implementation of multiple clinical development 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 on Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs), and who lead Clinical Strategy Teams (CSTs) and clinical study teams, to ensure high-quality, cross-functionally-aligned program (i.e., Clinical Development Plan) 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 two levels of Medical and Scientific Directors (typically 2 to 4 direct; 6 or more overall) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development 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.
In rare circumstances, may lead a CST for an unusually complex, high-priority program. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to ADTs and ALBs, and/or other cross-functional teams and internal stakeholders.
Serves as the in-house clinical and drug development expert broadly across several molecules and disease areas in the therapeutic area, directing appropriate scientific activities with internal stakeholders as they relate to ongoing projects. May lead clinical development contributions to due diligence or other business development activity. Contributes in partnership with Discovery colleagues to design and implementation of translational strategies at a disease area and platform level.
Acts as a senior-level liaison for 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 disease area strategies and Clinical 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 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.