Senior Director, Program Lead - Infectious Diseases

Caraway Therapeutics; Rahway (NJ); Hybrid; USD 210,000 - 331,000; Full time

Job summary

Merck in Rahway, NJ seeks an senior clinical operations leader to drive global, cross-functional development programs from planning through post‑marketing approval.

You will direct teams across programs, manage clinical operations timelines, quality systems, and regulatory interactions, and work with PSRM and CQRM to ensure project success. The role demands extensive pharmaceutical and clinical development expertise and strong leadership in a matrix environment.

Qualifications

• Must have deep knowledge of GCP and ICH regulations.
• Extensive experience in end-to-end clinical development programs.
• Ability to manage cross-functional, global teams and budgets.

Responsibilities

• Lead program planning and execution across disease areas and assets.
• Oversee Clinical Operations schedules and milestones.
• Provide operational input on protocol design and development plans.
• Manage site feasibility, enrollment, and vendor strategies.
• Mentor Trial Managers and develop staff.

Skills

GCP & ICH regs

End-to-end clinical development

Digital/AI-enabled approaches

Clinical databases & data review tools

Project management

Stakeholder leadership

Regulatory submissions

Quality & risk management

Education

Bachelor’s degree

Master’s degree

PhD/PharmD

Tools

Clinical Databases

RBQM platforms

Data review tools

Job description

Job Description

This position provides expert strategic and operational leadership in the planning and execution of highly complex program(s) (e.g., spanning multiple disease areas/indications, involving large outcome trials). In this position, you will have the opportunity to lead and direct global, cross-functional teams in end-to-end clinical development activities (strategic planning through post-marketing approval). You will apply project management and organizational leadership expertise in our fast paced, industry-leading, dynamic bio-pharmaceutical company. You will have both direct & indirect reports, managing team(s) across programs/within a disease area.

Your responsibility in this role will include:

• Leading and directing teams within a program/disease area/asset on key program planning and execution elements (e.g., program-level overviews; senior management and governance meetings)
• Providing operational input at the CST level during protocol design (e.g., feasibility, execution risk, operational implications of design choices) and on program-level development planning documents (e.g., Clinical Development Plan, Protocol Concept Sheet, Protocol), ensuring program-level consistency and delivery of program objectives
• Developing and maintaining the Clinical Operations Project Schedule, defining timelines for key trial milestones (e.g., DBL), and providing ongoing operational oversight of trial plan deliverables (e.g., Central Lab plan, Specimen Management Plan)
• Providing program-, disease-area, or asset-level oversight & context to inform trial-level enrollment, site feasibility & selection, and leading patient and site engagement strategies with Patient Advocacy Groups and Key Opinion Leaders across trials
• Conducting resource planning and staffing across a program, disease area, or asset (hiring and/or project onboarding; management of Trial Managers; may include management of other Program Leads)
• Holding overarching responsibility and oversight of program, disease-area, or asset-level execution, providing innovative ideas to achieve organizational objectives, tracking key trial milestones and metrics across the program, proactively managing delays, and surfacing execution risks
• Leading efforts and applying expertise to maximize operational feasibility and efficiency, and ensuring consistency and quality across the assigned portfolio
• Serving as the primary escalation point for trial teams on operational issues, fielding and resolving cross-functional issues, promoting cross-functional solutions, and escalating to management as needed
• Partnering with Portfolio Sourcing & Relationship Management (PSRM) on program-level service provider strategy (e.g., selection, qualification, contracting, oversight), resolving escalated issues and promoting consistent standards across studies
• Reviewing and providing expert operational input on trial-level regulatory submissions (e.g., IND, CTA, Article 46), Health Authority responses and meeting material, Risk Language, and the Clinical Study Report
• Reviewing trial-level ADI/RAID logs, Quality Plans, and readouts from quality metric dashboards (e.g., protocol deviations, temperature excursions), and proactively identifying and minimizing operational risks across the program/disease area/asset (e.g., clinical supply disruptions, service provider performance issues), escalating issues to CST and PDT as needed
• Collaborating with CQRM, CQOM, and CST to develop, maintain, and review the program-level RACT (including program-specific metrics and thresholds, e.g., KRIs, QTLs), and reviewing and approving the Program Quality Plan
• Reviewing protocol-level CTQ factors and key trial plans to ensure program-/disease-area/asset-level consistency as appropriate and quality control (e.g., reduction of manual data tracking/review efforts, appropriate balance between site & central monitoring)
• Owning proactive inspection readiness across the trial/program lifecycle, including supporting the authoring of post-inspection observation responses and CAPA/SQI management, in close collaboration with Clinical Quality Operations
• Serving as the operational representative on the Product Development's Clinical Subteam to elevate trial-/program-/disease-area-/asset-level risks, quality issues, and timeline/cost challenges, integrating solutions into program-level planning
• Collaborating and facilitating interactions with key internal and external stakeholders (e.g., KOLs, vendors) in support of clinical program/disease-area/asset objectives
• Leading and implementing process improvement and strategic initiatives (e.g., digital transformation)
• Potentially leading operational components of mergers and acquisitions (e.g., due diligence activities, portfolio integrations)
• Training, upskilling, and supervising direct and indirect reports, and managing the professional development and performance of direct reports, which may include Trial Managers and other Program Leaders
• Supporting CTT onboarding and developing Trial Manager role-specific training
• Championing and driving initiatives for digital proficiency/AI fluency to enhance efficiency and data-driven decision-making in clinical operations

Qualifications, Skills & Experience:

• Expert knowledge of GCP and ICH regulations
• Expert understanding of end-to-end clinical research process, TA, and competitive landscape
• Drives strategic adoption of scalable digital and AI-enabled approaches; experience in reviewing AI output, understanding limitations and constraints
• Advanced knowledge of clinical database platforms, central monitoring/RBQM platforms & data review tools
• Demonstrate advanced delegation, project-management, and program-wide decision-making skills to meet business needs and drive changes that shape the support, resourcing, and implementation of projects, programs, and/or technologies according to a budget/project plan
• Ability to interact collaboratively and navigate high-stake conflicts with key internal/external stakeholders, leading through deep expertise and strategic influence
• Demonstrate advanced problem solving, critical thinking, and scenario-planning skills (i.e. resolving complex technical, operational, and financial problems by weighing resource availability against department objectives), keeping an enterprise vision/view
• Demonstrate advanced verbal and written communication skills
• Demonstrate strong leadership by influencing internal & external stakeholders, and building talent through oversight, coaching, and mentoring

Education/Experience:

• Bachelor’s degree + 15 years
• Master’s + 12 years
• PhD/PharmD + a minimum of 8 years Pharmaceutical and/or clinical drug development experience.

Preferred:

• Degree in life sciences, preferred.
• Project Management Professional (PMP) certification preferred
• Experience in conducting pragmatic studies preferred

clinicaltrialjobs

#EligibleforERP

Required Skills:

AI Enablement, Clinical Databases, Clinical Research, Clinical Trials Monitoring, Cross-Functional Teamwork, Data Management, Ethical Standards, ICH Guidelines, Operational Leadership, Project Management, Regulatory Submissions, Scientific Writing, Therapeutic Knowledge

Preferred Skills:

Adaptability, Innovation, Strategic Thinking

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:

EEOC Know Your Rights

EEOC GINA Supplement

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.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$210,400.00 - $331,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 https://jobs.merck.com/us/en/compensation-and-benefits .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

11/18/2026

*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.