AbbVie is looking for an Associate Director of Design Validation, Clinical and Submission Support Services to join their Combination Product Development (CPD) team to contribute to the development and launch of new drug delivery systems. This individual will represent Combination Product Development function to support clinical studies, regulatory submissions and commercial launch well as build capabilities within the department. As discipline expert, drives functional performance by designing and developing innovative engineering technical solutions that contribute to significant success of the corporation. An independent reviewer to subordinates, peers, and senior management. A key AbbVie discipline contact.
- Responsibilities of this engineering grade level inherently include and expand upon the responsibilities established for lower engineering grade levels within technical consultant career track.
- Responsible for compliance with applicable policies and procedures. Ensures quality and effectiveness of key results of major projects within function through sound design, early risk assessments, and implementation of fallback strategies. Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes. Mitigates risk within functions through sound design, early risk assessments and implementation of fallback strategies.
- Sets discipline strategy in alignment with functional goals and key engineering objectives. Develops key engineering objectives. Collaborates with experts within function or discipline to integrate engineering objectives into activities associated with development of innovative products or technology. Advances engineering expertise across functions or disciplines. Proactively mentors, advises and shares opinions with subordinates, peers, and senior management.
- Mentors and trains functional leaders.Develops network valued by functional leaders. Actively supports open exchange of expert functional or discipline knowledge. Deepens insight to current and emerging business challenges enabling functional goal achievement. Organizes internal engineering technical exchanges. Develops and maintains external reputation as discipline expert.
- Influences industry with presentations, serving on panel discussions at industry meetings, attending industry meetings, or authoring articles for peer-reviewed publications. Collaborates with internal regulatory experts to ensure compliance with regulatory submissions.
- Presents innovative engineering concepts and results for function engineering and non-engineering leaders as well as potential and existing partners. Maximizes impact and value of expertise. Assesses challenges. Creatively applies knowledge of concepts, principles and theories. Develops and continually advances engineering direction. Identifies emerging trends from multiple internal and external sources.
- Determines and drives use of innovation. Integrates trends into functional short-term objectives. Advances cross-discipline technology and direction. Creates, invents, designs and implements new or better approaches, alternatives and breakthrough ideas that are valued by customers across functions or disciplines. Generates institutional knowledge. Develops and advances existing and breakthrough technology. Provides advice and counsel with respect to intellectual property.
- Solicits feedback to better understand unmet market needs, integrates inputs into discipline strategy to successfully achieve functional goals. Gathers and understands the relevant facts necessary to support optimal technical decisions. Develops strong awareness of other disciplines/organizational dependencies and challenges to appropriately develop functional strategy and performance goals. Provides engineering leadership and mentoring.
- Bachelor or Master’s of Science Degree in Engineering or related field with 12+ years of significant engineering and/or operational experience.
- The incumbent's career must be marked by a consistent series of technical contributions and accomplishments. Significant contribution to product or process development or improvement through creative application of technical effort will equally be recognized.
- Evidence (e.g., peer recognition, society participation, publications, patents and/or mentoring) must be provided of demonstrated excellence in the broad area of the incumbent's discipline. The incumbent must possess general depth and breadth within an engineering discipline rather than just focused excellence within a narrow segment of a specific discipline.
- Ability to advise the various functions within the division on how they can manage their particular risks.
- Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
- Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
- Works well with other engineers in a collaborative, fast-paced goal-driven environment.
- Interpersonal skills to negotiate and reconcile interdisciplinary differences optimizing overall organizational goals.
- Technical background in health care, medical devices, biological, or pharmaceutical companies.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 25 % of the Time
Job Type: Experienced