Senior Director, Clinical and Regulatory Strategic Communications - Hybrid

Job Description

The Clinical and Regulatory Strategic Communications (CRSC) department within GCTO creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials.

The Senior Director of Strategy, Technology & Operations is a key strategic and operational partner to the Head of CRSC, enabling execution of CRSC priorities across the organization. This role integrates enterprise strategy execution, operational leadership, and technology innovation to advance efficiency, quality, and scalability across CRSC. The position is responsible for translating strategic priorities into actionable programs, leading cross-functional initiatives, and advancing AI- and technology-enabled capabilities to modernize CRSC processes.

Key Responsibilities

Strategy & Operational Leadership

• Serve as a strategic partner to the Head of CRSC, ensuring alignment of priorities, resources, and execution.
• Lead annual strategic planning, operating model development, and priority-setting for CRSC.
• Establish and maintain governance structures, including leadership forums, decision frameworks, and initiative tracking.
• Drive coordination across CRSC and partner functions (e.g., Clinical Development, Regulatory Affairs, Data/IT, Quality).
• Develop executive-level communications (e.g., leadership updates, town halls, strategic messaging).
• Translate enterprise and functional strategies into structured programs, milestones, and measurable outcomes.
• Support cross-functional CRSC initiatives that enhance efficiency, quality, and scalability.
• Develop and oversee department dashboards, metrics, and reporting frameworks.
• Ensure effective change management, communication, and adoption of new processes and technologies.
• Support the Head of CRSC in aligning initiatives with broader GCTO transformation efforts.
• Define workforce strategies to support evolving AI, digital, and operational capabilities.
• Foster a culture of innovation, accountability, and continuous improvement.

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Technology Strategy & Digital Enablement

• Define and advance the CRSC technology and innovation roadmap aligned to GCTO and enterprise objectives.
• Oversee development, implementation, and optimization of tools supporting CRSC.
• Partner with IT and digital teams to ensure alignment with enterprise architecture, data governance, and compliance standards.
• Evaluate and guide technology investment decisions (build vs. buy; vendor selection and oversight).
• Ensure that all technology and AI initiatives align with clinical regulatory requirements, internal quality standards, and inspection readiness expectations.

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AI Strategy & Innovation

• Lead identification and implementation of AI-enabled use cases within CRSC (e.g., draft generation, summarization, review support, document comparison).
• Establish and maintain responsible AI governance, including risk management, validation approaches, and compliance with regulatory expectations.
• Drive development of prompt libraries, reusable workflows, and training approaches to enable adoption.
• Define and track KPIs to evaluate impact on cycle time, quality, and operational efficiency.- -

Qualifications

• Bachelor's degree or higher preferably in a health, scientific, technology or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 15+ years relevant pharmaceutical or biotech industry (e.g., medical writing, regulatory communications, or clinical development)..

Required Experience :

• Expertise and thorough knowledge of the regulatory requirements and technical specifications for the assembly, structure, content, formatting, quality control and submission/transmission of all documents for regulatory submissions using the CTD process and managing the associated requests from regulators.
• Expertise and understanding of global and local disclosure laws, end-to-end drug development, and clinical trial processes.
• Experience in planning and leading strategic initiatives.

Preferred

• Experience leading digital transformation and technology modernization efforts-including platform implementations, automation, data and analytics enablement, and change adoption-while driving the adoption of pragmatic AI and other technology solutions in alignment with scientific and regulatory standards, quality expectations, and appropriate governance controls.

Required Skills

• Strong interpersonal and communications skills.
• Demonstrated ability to drive and manage highly complex topics.-
• Strong decision-making and analytical skills. Ability to influence and drive a broader view of issues to maximize benefit and/or impact across the organization.
• Demonstrated leadership skills in managing people, programs, processes, leading meetings and influencing matrix environments.
• Advanced problem solving, conflict resolution, and critical thinking skills.
• Expert knowledge of GCP and ICH regulations and corporate policies.

clinicaltrialjobs -

EligibleforERP

Required Skills:
Clinical Development, Clinical Research Management, Conflict Resolution, Data Governance, Innovation, Inspection Readiness, Medical Writing, New Technology Integration, Operational Efficiency, Pharmaceutical Quality Assurance, Scientific Writing, Strategic Management, Strategic Messaging, Strategic Planning, Technology Investments

Preferred Skills:

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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 click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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The salary range for this role is
$173,200.00 - $272,600.00

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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
Yes

Hazardous Material(s):
No

Job Posting End Date:
07/10/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R404615