Job Description

The Director will lead a business-critical organization responsible for regulatory data management, informatics and analytics, and enterprise data system business ownership. This role enables the delivery of trusted scientific and regulatory data across the product lifecycle -- from IND through NDA/BLA submissions, post-filing activities, product monitoring, and inspection readiness— while advancing scalable digital solutions that improve data accessibility, automate manual processes, strengthen compliance, and enable data-driven decision-making. Partnering across Analytical Development, Regulatory CMC, Quality, Digital, our Research & Development Division, and our Manufacturing Division organizations, the Director will align business priorities, deliver sustainable digital capabilities, and build a high-performing team that accelerates scientific innovation and digital transformation

• Lead an integrated organization supporting regulatory data management, informatics analytics, and enterprise data system capabilities that enable scientific excellence, regulatory compliance, and digital transformation.
• Deliver accurate, traceable, and submission-ready regulatory data across the product lifecycle (from IND, NDA/BLA to post-approval filings).
• Advance scalable analytics, visualization, and self-service data solutions that support proactive product monitoring, operational transparency, accelerate insights, and support data-driven decisions.
• Serve as business owner or representative for enterprise data systems, driving strategy, governance, enhancements, adoption, and business value.
• Translate scientific, regulatory, quality, and business needs into scalable digital capabilities and data solutions that improve efficiency, strengthen compliance, and maximize the value of enterprise data assets.
• Partner across scientific, regulatory, quality, and technology organizations to deliver scalable, sustainable, and compliant solutions.
• Drive standardization, automation, and continuous improvement to enhance data quality, traceability, and operational efficiency.
• Ensure solutions are compliant, inspection-ready, scalable, and aligned with enterprise data and digital strategies.

Required

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, Data Science, Statistics, Computer Science, Engineering, or related discipline with at least fifteen (15) years of analytical development, chemistry, pharmaceutical sciences, informatics, data science, regulatory CMC, Quality, or a related experience; OR Master's degree with at least ten (10) years or Ph.D. with at least seven (7) years.
• Proven leadership of data management, informatics, analytics, laboratory systems, enterprise data platforms, or digital transformation initiatives in a regulated environment.
• Strong people leadership, stakeholder management, and cross-functional influence skills with a track record of building high-performing teams and delivering business results.
• Working knowledge of data integrity, regulatory requirements, quality systems, laboratory operations, and enterprise system lifecycle management.
• Strong strategic thinking, business acumen, change leadership, stakeholder engagement, execution, and problem-solving skills, with a track record of delivering measurable business value through people, processes, data, and technology.

Preferred

• Experience in managing diverse teams of scientists, contractors, and cross-functional contributors.
• Experience supporting regulatory submissions and post-filing activities from IND through NDA/BLA.
• Experience applying analytical laboratory expertise to improve scientific data generation, review, and consumption across development, stability, quality, and regulatory workflows.
• Experience serving as a business owner or product owner for enterprise systems, digital products, or data capabilities.
• Knowledge of AI/GenAI, advanced analytics, or emerging digital technologies and their application to scientific and regulatory data workflows.
• Experience delivering trusted, compliant, and inspection-ready scientific and regulatory data that support development, regulatory submissions, and commercial products.
• Demonstrated ability to develop scalable digital capabilities that improve data accessibility, increase automation, strengthen compliance, and enable data-driven decisions.

Required Skills:

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.