The Director, Scientific Research is accountable for processes, standards and compliance monitoring supporting scientific research activities, ensuring scientific information meet standards expected across the pharmaceutical industry, including Good Pharmacoepidemiology Practices (GPP), Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) where applicable.
This role is accountable for implementing business processes, compliance with policies and procedures, strategy and training, and productivity initiatives. In addition, this role is responsible to build positive and collaborative relationships in matrixed and cross-functional team environments incorporating diverse groups from Global Medical Affairs headquarters and affiliates, Health Economics and Outcomes Research (HEOR), Pharmacovigilance, Quality Assurance, Clinical Development, Regulatory, Legal, and Office of Ethics and Compliance (OEC) and other related functional areas when needed.
- Accountable for compliance, standards and processes related to evidence generation activities (e.g., AbbVie sponsored non-interventional studies, Investigator Initiated Studies (IIS), collaborative research, exploratory data analysis, external data collection support) across Global Medical Affairs (GMA)
- Maintain oversight and expert knowledge of major industry regulations and guidelines (e.g., FDA, EMA, EFPIA), which apply to scientific research, and ensure applicable GMA research related policies and procedures properly reflect the regulation and guidance and employees are trained to do their jobs through development, maintenance, and reporting of role-based training plans. Expertise stretches to include regulatory impact, global business requirements, knowledge of industry trends and processes
- Assess changes in major industry regulations, guidelines, and best practices for impact on scientific research activities across GMA. Provide recommendations to senior or executive level management to define and implement improvement strategies and priorities. Foster communications across GMA to implement risk management strategies
- Provide managerial oversight for the Research Compliance team and GMA-wide compliance monitoring activities
- Establish, maintain, and expand business relationships with AbbVie-wide cross-functional colleagues to ensure awareness and application of scientific research standards and business processes
- Represent Medical Compliance Excellence and GMA at organizational cross-functional team meetings and initiatives by actively contributing expertise and insights to discussions, and sharing important information with Medical Compliance Excellence staff and colleagues
- Bachelor’s degree (or equivalent ex-US) is required, typically in nursing or scientific field. Advanced degree is preferred.
- Must have 10+ years of Pharma-related/ clinical research related experience (and/or applicable work experience); including 5-7 years (and/or applicable work experience) in clinical research demonstrating a high level of core, technical and leadership competencies through setting and driving strategy and leading a global team
- 3 years of people management experience; demonstrated successful coaching/ mentoring
- Considered a leader in the development and application of standard business processes
- Possess strong communication skills and exhibit robust decision-making skills
- Comfortable reaching decisions with limited information
- Experience working in a complex and matrix environment, and with numerous partners
Considered a Subject Matter Expert and competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)
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.