Director, US Study Start-up Head
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 Area SSU Head is responsible and accountable for driving on-time, budget and quality delivery, execution, management, and oversight of start up and maintenance activities of the pipeline and Global Medical Affairs clinical studies within area.
The US Director, Study Start Up and Maintenance is responsible for management and/or oversight of Area Leads and Start Up Specialists located in the US. Due to the significantly larger scope of studies in the US, this role will manage a team of over 90 people and study responsibilities.
Primary responsibilities include but are not limited to:
- line manager for Area SSU Leads and responsible for their growth and development
- accountable for managing resourcing, hiring, performance reviews and talent development for designated area SSU staff
- providing start up focused strategic input on the area and country strategy, start up timelines, site profiles and risks assessment for the Area
- establishing country/site activation plans including risk assessments and mitigation planning for the Area
- driving maintenance of country and site intelligence for assigned area
- provide area start up updates and metrics to Area Director, Global SSU Leads
- leading area quality management through risk-based thinking
-Driving a learning environment (best practice sharing, and lessons learned) and ensuring continuous improvement in area/country performance by using innovative approaches, active analysis of Key Risk and Performance Indicators, metrics, milestones, and benchmarking
-Managing identified risks to start-up through development of effective mitigation plans
-Ensuring audit/inspection readiness at all times and compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines
- Working collaboratively with the CSM Area Director and Global SSU Head to:
- Implement resourcing and training strategies in response to changes affecting Area, including effective organizational change management
-Provide consistent best practice approach to onboarding (incl. for Start-up Specialists) and defining best practice training curriculum for the SSU roles.
- Leading simplicity in process and approach, and enhancing agility, including leading area training and development of SOPs, job aids and work instructions in collaboration with Global SSU Head, CSM Area Directors and partnership with other SSU Area Heads
-assure alignment and standardization of process with other SSU Areas. Consolidate “lessons learned”
across areas and incorporating into SSU training materials,
- Working collaboratively and partnering with all key stakeholders, including Global SSU Head, CSM Global/Area Clinical Study Leads (titles tbc), Contracting & Purchasing, Regulatory Affairs/CTS, to facilitate cross-functional communication and collaboration
- Participating in process improvement initiatives as required
'- Bachelor's Degree required, degree in health care or scientific field preferred
- Minimum of 10 years of clinical research experience, preferably with 6+ years of relevant study start up management experience
- Minimum of 5 years of experience in line management of people including acquisition of talent, performance management, growth and development, managing employee relations, coaching and mentoring of staff and teams.
-Proven leadership skills in a cross-functional global team environment, experience in managing remote/virtual teams, and an ability to influence and align stakeholders, while modeling and driving AbbVie’s leadership attributes.
-Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to build trust and communicate persuasively and with clarity, flexibility, and adaptability to changing requirements.
- Expertise in drug development, operations, and resource/budget planning across global geographies
-Demonstration of successful program execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment
- Advanced working knowledge of ICH and GCP guidelines and operational understanding of the global regulatory environment
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 10 % 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.