Senior Director, Combination Product Development at 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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

TheAbbVie Combination Product Development and Drug Delivery (CPD-DD) group provides design and development expertise to enable drug delivery systems for AbbVie biopharmaceuticals. Within CPD-DD, it is the Landscaping & Platform Definition (L&PD) group which conducts a periodic assessment of AbbVies drug pipeline and identifies future delivery needs. Coordinating across the business, the L&PD team collects the business and technical delivery needs for future drug delivery systems, identifies potential external technology partners, evaluates the fitness of their offerings to promising ones that best fit those needs and recommends potential delivery system platforms that can be developed to meet these needs. The CPD-DD group operates in three geographies Lake County (Chicago area) Illinois, Ludwigshafen, Germany and Irvine, California.

Overview of Position:

We are seeking an experienced senior leader to lead the Landscaping & Platform Definition (L&PD) team, based in Lake County, Illinois. The scope of drug delivery systems this group supports range from simple oral syringes, eyecare dropper bottles, pre-filled syringes, auto-injectors, on-body injectors, intra-ocular drug delivery systems and continuous sub-cutaneous infusion pumps. These delivery systems support all AbbVie therapeutic areas. The individual we are seeking will have led the development of regulated medical devices or delivery systems across a variety of therapeutic areas.

The individual must be comfortable in the detailed technical assessment of delivery systems as well as steering a broad, strategic assessment of the broad business needs. The individual must be experienced in drug delivery, medical devices and combination products - and familiar enough with medical device development processes to be able to ensure the timelines developed by the L&PD team are grounded cross-functionally and tradeoffs between the various delivery solutions identified by the team are grounded and well documented. In addition, we expect the individual to be a passionate advocate to ensure that user needs are identified and drive any technology evaluation and proposed platform.

This individual will collaborate with internal partners as well as external organizations and potential partners. The work with external partners involves the development of relationships with third-party development partners outside of the United States, and this individual is expected to foster the ongoing relationship. Thus, the role requires periodic face-to-face visits in addition to regular teleconferences.

The individual will perform the following activities:

• Drive a periodically assessment of the drug pipeline through coordination with asset teams
• Develop a holistic summary of current and proposed delivery systems and identification of pipeline gaps
• Ensure consistent and thorough business and technical needs assessments
• Oversee an ongoing fund for drug delivery feasibility activities; ensuring the assessments represent each of the key delivery modes and include both technology assessments as well as Contextual Inquiry research
• Maintain familiarity with external delivery system manufacturers used to steer the landscape assessments
• Evaluate the landscape and identify leading candidates, based on technical fitness and business criteria
• Scope feasibility assessment needs (e.g., for dose accuracy), request proposals and manage the budgets
• Conduct and manage these feasibility contracts with the external firm
• Prepare preliminary timelines for execution - feasibility and development.
• Present to CPD-DD and Senior AbbVie leadership to gain alignment.
• Meet with internal stakeholders and review and assess options for fitness for purpose
• Prepare and share documentation leading to decisions to proceed to feasibility

Qualifications

• MS, or PhD in Mechanical, Biomedical or related engineering discipline.
• Strong working knowledge of design control and combination product and device development
• 20 years (with MS) or 14 years (with PhD) experience in product development with a preferred of 10-14 years in medical devices and drug delivery, spanning design, development, verification and validation
• MBA or business-related experience (finance, licensing, contract scoping) is preferred
• Experience leading product device design and development of regulated medical devices and delivery system platforms from initial concept to release-to-market
• Excellent written and spoken communications skills and history of published papers, books and patents
• Ability to work with a variety of disciplines and teams in fast-paced environments
• Ability to influence and negotiate internally and externally as a part of global team
• Strong problem-solving and analytical skills
• Working knowledge with medical devices and medical device regulations and standards is preferred
• Ability to identify and lead improvement initiatives, coach/train individuals, and stimulate innovation.
• Travel will be required, as necessary (10%-20%)

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

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