Director, Evidence Solutions
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.
Director, Global Medical Trial Management
The Director, Global Medical Trial Management (GMTM) is responsible for the successful and timely completion of AbbVie/Allergan sponsored, post-marketing clinical research projects assigned for their corresponding therapeutic or functional areas. This includes projects originating from Medical Affairs, HEOR, or Epidemiology assigned directly to the Director and those assigned to departmental Trial Managers. Under the supervision of the Associate VP of GMTM, the Director ensures alignment of new projects with product strategic imperatives by working closely with internal stakeholders to optimize study design. The Director shall provide leadership to their assigned global GMTM direct reports. The Director is expected to actively participate as a member of the GMTM Leadership Team, model adherence to established departmental processes and applicable regulations, and provide recommendations for improvement.
The employee must conduct their global work activities in compliance with all AbbVie/Allergan internal requirements and with all applicable local regulatory requirements. AbbVie/Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
- Ensure alignment of new projects with the strategic imperatives of assigned TA or functional remit. Oversee and/or directly participate in the development of study plans with TA or functional leadership to ensure that strategic requirements of the project are achievable and properly reflected, including milestones, budget, and study design.
- Assist TA or functional leadership in study ideation and strategic problem solving. Makes decisions on redeployment of resources to address priorities.
- Ensure appropriate communication to senior management as required, including applicable plans and study progress.
- Ensure successful and timely delivery of all clinical research projects for assigned TAs or functional areas based on agreed upon timelines, budgets and designs. This includes projects assigned directly to the Director and those aligned with assigned TA or functional areas.
- Provide assistance as required to GMTM Trial Managers so they may successfully complete trials, such as vendor selection, creation of study documents (e.g. study protocol, study design), problem solving for enrollment issues and ensuring that studies are operationally executable.
- Ensures study execution is consistent with product strategy, corporate compliance guidance, applicable GCP, and GMTM processes.
- Coordinates study-related activities with internal stakeholders and partners to initiate and successfully complete studies with the goal of highest clinical science and integrity and for the maximum benefit of the company. Provides clear communication to senior management. Tracks programs against plans and benchmarks productivity.
- Provide leadership for GMTM direct reports and study-aligned GMTM Trial Managers. Ensure proper alignment and workload balance of clinical projects among assigned GMTM team members. Conduct meetings with team members for delivery of coaching and mentoring as appropriate.
- Ensure that team members are functioning effectively and in accordance with current SOPs, policies, processes and regulatory requirements. Conduct midyear and annual APR/IDP meetings with all direct reports. Advocate for team member developmental needs. Provide timely feedback, coaching and counseling in partnership with Human Resources.
- Deliver continuous improvement for the GMTM function. Actively participate as a member of the GMTM Leadership Team, model adherence to established departmental norms, and provide recommendations for improvement.
- Deliver on annual team project commitments and ensure that team members deliver on theirs. Ensure delivery of proper trial management administration, such as forecasting and spending targets.
- Encourage bold and decisive action among team members to achieve objectives, including creative problem solving and use of resources. Provide recommendations for departmental annual plans designed to improve departmental efficiencies, grow team capabilities, and to deliver greater value to AbbVie/Allergan.
Education and Experience
- 7-10 years of experience in executing clinical research studies
- BS with 7-10 years of pharmaceutical industry or related health care research/education/marketing experience OR MS with 5-7 years of pharmaceutical industry or related health care research/education/marketing experience required
- Science degree or health-related field preferred
Essential Skills and Abilities
- Expert in the conduct of late phase clinical research
- Expert in study design and protocol development
- Demonstrated ability to think strategically across multiple AbbVie/Allergan TAs
- Ability to work collaboratively with internal and external stakeholders
- Superior problem-solving skills
- Proactive approach to delivery of project commitments
- Excellent communication skills, both oral and written, with proven ability to communicate wth stakeholders of varying levels, including AbbVie/Allergan senior leadership
- Ability to manage GMTM Trial Managers located locally and globally
- Demonstrated ability to work effectively with others in a matrix environment
- Demonstrated ability to effectively manage multiple projects
- Demostrated knowledge, application, and support for relevant compliance guidelines
- Ability to travel as required
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 15 % 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.