Senior Director, CMC Dossier Leadership - AbbVie

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 Twitter, Facebook, Instagram, YouTube and LinkedIn. 

The Senior Director of CMC Dossier Leadership will lead an experienced team responsible for the creation and management of high-quality CMC submission strategies and Module 3 regulatory documents. Reporting to the VP CMC Strategy and Portfolio Leadership, they will act as a trusted cross-functional advisor to AbbVie leadership, serve as a key opinion leader and expert resource for project teams, and provide an environment for team members to develop in their careers into leadership positions throughout AbbVie.

This is a role for a visionary leader with a passion for scientific excellence and regulatory strategy.

Key Responsibilities

• Lead and develop a team of 15-25 professionals, ensuring alignment of CMC strategies across the organization and holding team accountable for business deliverables. Foster a culture of excellence, accountability, and career growth while developing staff in alignment with business needs, external factors, and individual development objectives. Prioritize enterprise culture initiatives and implementation.
• Ensure function’s deliverables are completed on time, within budget, meeting high standards of quality and safety. Hold team members accountable for submission timing, quality, and effective data presentation.
• Advance function’s capabilities based on emerging modalities and technologies to support future pipeline submissions.
• Collaborate with and advise CMC project teams in R&D and Operations related to compliant development strategies.
• Identify key business objectives, set relevant cross-functional goals, and engage with stakeholders to implement aligned action plans.
• Develop and implements short-term and long-term plans to achieve goals set by senior management. Drive consensus for goals to meet the short and long-range plans.
• Identify emerging regulatory trends impacting CMC development and proactively drive best practices to maintain/build compliant and efficient control strategies, bringing broad visibility to key topics and changes.
• Identify high-impact external opportunities and drive team participation in pre-competitive industry consortia to implement cutting edge control strategies.
• Provide oversight and strategic guidance to white papers and policies to illustrate current development expectations to support regulatory submissions.
• Work closely with Regulatory Affairs to ensure alignment of expectations for CMC control strategies in submissions.

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or a related field. An advanced degree is preferred.
• 15+ years in the pharmaceutical industry, including 7+ in leadership roles. Higher education may compensate for years of experience.
• Proven track record of developing and implementing successful global CMC control strategies. Experience interfacing with regulatory agencies preferred.
• Success in leading within complex, matrixed environments
• Demonstrated ability to grow capabilities of an organization and develop people into future leaders.
• Strong oral and written communication skills
• Ability to solve critical business and scientific problems
• Ability to be based from our Lake County, IL headquarters (North Chicago)

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

• This job is eligible to participate in our long-term incentive programs​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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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.

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

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