Associate Director, Biologics CMC Data Strategy Lead

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.

Job Description

Biologics CMC, a part of Development Sciences within AbbVie’s R&D, is a global organization that is responsible for defining and advancing pipeline assets from Discovery Research through to Phase 3 clinical trials for biologics (proteins, conjugates, peptides, neurotoxins etc.) and genetic medicine (AAV, LNPs, Cell Therapy).

We are looking for a Biologics CMC Data Strategy Lead who will develop, oversee and drive the data and digital strategy within BioCMC. They will be responsible for partnering with the Dev Sci Digital Transformation team and functional BioCMC scientists/leaders to develop projects from conception to execution. Additionally, they will lead the establishment of a data governance strategy to ensure the effective execution of projects in alignment with overall BioCMC objectives. A key goal for this role will be the overall enhancement of data capture processes within the organization to enable the broad application of AI/ML tools. This role will also function alongside the Dev Sci Digital Transformation (DSDT) team as the key interface for data activities between BioCMC, and peer organizations (Discovery Research, PDS&T and other Dev Sci Functional Organizations).

• Drive an aligned overall BioCMC data strategy and serve as the key point of contact to the Dev Sci Digital Transformation team by communicating priorities and ensuring the DSDT efforts remain connected to them
• Resolve key project hurdles by establishing and fostering partnerships with key stakeholders across BioCMC scientists, area VPs, DSDT and IT to facilitate effective collaboration
• Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and management
• Establish processes, templates/resources, and governance to support key business updates, decisions, and communication opportunities
• Initiate and/or support scientific data initiatives to drive innovation, continuously enhance capabilities and platforms, and improve business processes from data capture to visualization to downstream automated regulatory reports
• Understand and adhere to corporate standards regarding applicable Corporate and Divisional Policies, including code of conduct, safety, GxP compliance, and data security
• Build and promote use case lead best practices within the organization through mentoring and guiding BioCMC scientists

Qualifications

• Bachelor's Degree with scientific or business field 9 years’ experience; Master's Degree with 8 years’ experience; PhD with 4 years’ experience. MBA or PhD in scientific field preferred
• 7-10 years of experience with multi-faceted, broad based understanding of Pharma R&D business processes; fewer years can be considered if candidate has advanced degrees (MBA, PhD)
• Demonstrated excellent communication skills (written and verbal) across a variety of mediums and stakeholders, including senior leaders.
• Demonstrated ability to partner with senior leaders, influence without authority, and navigate complexities in a matrixed environment.
• Demonstrated ability to manage multiple priorities simultaneously and to intended outcomes, iterating or changing course when required.
• Strong business acumen and project management skills with an ability to anticipate team, function, and business unit needs.
• Experience in working with complex data sets to solve business challenges by establishing robust measurement frameworks to deliver business value with data-driven insights to senior leaders.
• Preferred background with Biologics CMC (proteins, conjugates, peptides and/or neurotoxins) and/or genetic medicine (AAV, LNPs, cell therapy) data systems NGE, GRE, Prodev, Pega, etc.

Additional Information

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

• This is an on-site opportunity. 
• 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. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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