Scientific Associate Vice President, Digital Technologies – Development Sciences & Clinical Supplies

Merck • Rahway, NJ

2d • Hybrid

About The Position

The successful candidate will play a pivotal role in shaping the future of our CMC (Chemistry, Manufacturing & Controls) digital and data strategy transformation efforts across our R&D division and Manufacturing divisions.
The Scientific Associate Vice President role offers a unique opportunity to influence above project/ function strategy, drive digital adjacencies, and ensure connectivity of our data strategy efforts. Join us to make a significant impact on how we leverage data to define process and analytical method development and future data investments for our entire company pipeline.
Primary Responsibilities:
Partner with the Development Sciences & Clinical Supplies (DSCS) Digital Technologies Lead and CMC functional leaders to drive the development and execution of comprehensive digital strategies that enhance productivity, enhance end user experience and drive business value.
Recommend strategic direction and drive decisions that accelerate innovative digital solutions and new perspectives toward connecting data-driven investments across DSCS.
Shape the utilization of data in support of advancing the CMC portfolio to reduce filing timelines, drive capacity increases across labs and plants, and fortify supply chains through increased robustness of processes and analytical methods.
Connect into Discovery Research-facing digital efforts to facilitate the continuity of data between discovery and development work.
Operate at the interface of R&D and Manufacturing tool implementation for CMC, ensuring the necessary pull-through of lab data into our facility network.
Facilitate business-facing digital opportunities that include dashboards and visualization intended to drive operational efficiencies.
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.
Collaborate with cross-functional teams to align digital initiatives with business objectives.
Define digital goals, measure performance, and adjust strategies based on data-driven insights.
Manage vendor relationships, oversee digital budgets, and ensure compliance with regulations.
Stay current with emerging technologies such as artificial intelligence, machine learning, blockchain, and the Internet of Things.
Communicate complex digital concepts to non-technical stakeholders.
Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and management.
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 scientists.

Requirements

• Minimum 15 years of experience in new product introduction, with experience across pipeline process development, operations, and new technology builds.
• Recognized expert in the CMC space covering drug substance processes, drug product processes, and analytical methods, across both R&D and manufacturing, with a deep understanding of the connections between digital capabilities and CMC.
• Broad experience identifying, inventing, and implementing digital solutions for technical, operational, and/or business solutions that rely heavily on maximizing data access and utilization.
• Demonstrated ability to set and execute on strategic direction for programs, facilities, and strategic investments, especially those that impact multiple organizations and/or divisions.
• Demonstrated ability for innovative and complex problem-solving, both technically and strategically, across functions and divisions.
• Demonstrated ability for taking initiative, demonstrating creativity and innovation, and influencing without authority.
• Strength in delivering solutions and results on firm deadlines.
• Demonstrated ability for navigating complex, cross-divisional networks to deliver results and drive value for the enterprise.
• 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.

Nice To Haves

• 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.

Responsibilities

• Partner with the Development Sciences & Clinical Supplies (DSCS) Digital Technologies Lead and CMC functional leaders to drive the development and execution of comprehensive digital strategies that enhance productivity, enhance end user experience and drive business value.
• Recommend strategic direction and drive decisions that accelerate innovative digital solutions and new perspectives toward connecting data-driven investments across DSCS.
• Shape the utilization of data in support of advancing the CMC portfolio to reduce filing timelines, drive capacity increases across labs and plants, and fortify supply chains through increased robustness of processes and analytical methods.
• Connect into Discovery Research-facing digital efforts to facilitate the continuity of data between discovery and development work.
• Operate at the interface of R&D and Manufacturing tool implementation for CMC, ensuring the necessary pull-through of lab data into our facility network.
• Facilitate business-facing digital opportunities that include dashboards and visualization intended to drive operational efficiencies.
• 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.
• Collaborate with cross-functional teams to align digital initiatives with business objectives.
• Define digital goals, measure performance, and adjust strategies based on data-driven insights.
• Manage vendor relationships, oversee digital budgets, and ensure compliance with regulations.
• Stay current with emerging technologies such as artificial intelligence, machine learning, blockchain, and the Internet of Things.
• Communicate complex digital concepts to non-technical stakeholders.
• Effectively and timely communicate development plans, risks, and mitigation plans to stakeholders and management.
• 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 scientists.

Benefits

• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive