Easter Seals Jobs

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .

Job Description

The Associate Director, Area Study Start Up is responsible and accountable for on-time, budget and quality delivery and execution of the start-up and maintenance activities of the assigned pipeline and Global Medical Affairs clinical studies within area. The role reports into the Area SSU Head and serves as a single point of accountability across the area for the delivery and execution of the site start up and maintenance activities for the assigned studies within the area.

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, Area SSU Head, 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 Area SSU Head and Area SSU COMs to:

• Implement resourcing and training strategies in response to changes affecting Area, including effective organizational change management

• Deliver 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 other Area SSU COMs

• Consolidate “lessons learned" across areas and incorporating into SSU training materials,

• Working collaboratively and partnering with all key stakeholders to facilitate cross-functional communication and collaboration

• Participating in or leading cross-functional process improvement initiatives or special projects as required

Qualifications

• Bachelor's Degree, degree in health care or scientific field required

• Minimum of 12 years of clinical research experience, preferably with 5+ years of relevant study start up management experience

• Minimum of 4 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.

• Demonstration of successful development and retention of high potential/high performing staff

• Excellent working knowledge of all the roles encompassed in the preceding grade levels within the job family.

• Ability to work independently without significant oversight

• 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. Strong interpersonal skills with the ability to build trust and communicate persuasively and with clarity, flexibility and adaptability to changing requirements.

• Demonstration of successful program execution, preferably in start up, and aptitude for managing multiple priorities in a fast‐paced environment

• Demonstration of greater responsibility and accountability with additional tasks that support the business

• Advanced working knowledge of ICH and GCP guidelines and operational understanding of the global regulatory environment

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html