SMA Associate Director
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.
The SMA Associate Director is responsible to connect science and operations to bring clinical studies to life through the leadership and development of the front-line Clinical Study Leadership staff across all programs. Responsible for the development of the clinical operational staffing strategy and tactics in support of assigned clinical research programs, to ensure execution is with quality and efficiency, on-time, within budget, and in line with company objectives.
Clinical Development Programs (Phase 1-4) are the largest and most expensive part of the development lifecycle. Lack of delivery can have significant impact on asset regulatory approval timelines, and company revenue. The SMA Associate Director is a strategic people leader responsible for developing a talent pipeline for Clinical Study Leadership, and providing operational reality to our scientific experiments via robust leadership of that front-line staff.
- Responsible for developing, managing, mentoring clinical operations (direct and indirect) staff to enable growth into leadership roles, including strategic leadership and direct supervision of up to 10 talent manager(s) and up to 150 indirect staff.
- Responsible for creating an inclusive, innovative learning environment where staff and studies/program will suceed.
- Responsible for recruiting, hiring, training the front-line Clinical Study Leadership team and their Talent Manager, including therapeutic area training in collaboration with the TA. Administer performance reviews and manage any performance issues with input from CDO business partners while providing consistent level of expectations and stretch opportunites to ensure continuous growth.
- In alignment with asset strategies, provide a strategic plan for resourcing study management. Strategically plan for potential risks to study support and plan ahead with mitigations. Fluidly adjust plans as project priorities and/or timelines change. Include plans for secialized need for programs or working groups (e.g. PAA).
- Responsilble for maximizing the value of and efficiently utilizing AbbVie's most valuable resource (staff) in the front-line Clinical Study Leadership space.
- Interacts with and influences all levels of management and cross-functional team members to achieve high standards of output from front-line Clinical Study Leadership staff in delivering on program objectives: primary scope of influence is within Development Operations, cross-functional colleagues who support clinical trial execution.
- Leads innovation and initiatives with a defined focus that is either targeted for in function change or cross function clinical study process improvement and ensures effective change management across the cross-functional areas that support clinical program execution.
- Responsible for adherence to all relevant regulations including ICH, PhRMA, FDA CFR, EU Directive and other applicable local laws, as well as AbbVie's policies, SOPs and Work Instructions. Ongoing training in compliance areas and study management specific knowledge is expected in order to maintain a solid knowledge base for performing assigned tasks
- B.A/B.S with 10 years of experience; M.S. with 8 years of experience; MD/PharmD with 1 year of experience.
- Post graduate qualification in life science or equivalent with relevant experience in a related field (preferred)
- Ten (10) years study operations experience
- Minimum of one (1) year experience in Clinical Pharmacology (for Phase 1)
- At least (5) years’ experience in people management
Significant Work Activities
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.