Director, Program Lead - Immunology

MSD Malaysia; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical

Dental

Vision health care

401(k)

Paid holidays

Vacation

Compassionate and sick days

Job summary

Merck & Co., Rahway, NJ, seeks an experienced Program Lead to oversee the Tulisokibart IBD clinical program from strategic planning through post-approval. You will direct global cross-functional teams, apply project management expertise, and ensure program quality and adherence to GCP/ICH standards.

The ideal candidate has extensive pharmaceutical and clinical drug development experience, strong leadership, and exceptional communication skills to engage stakeholders across the organization.

Qualifications

• Bachelor’s degree in life sciences with 12+ years pharma/clinical development experience.
• Advanced knowledge of GCP/ICH regulations and industry standards.
• Proven ability to lead global cross-functional clinical programs from planning through post-approval.
• Excellent written and verbal English communication; effective in stakeholder interaction.

Responsibilities

• Oversee operational execution of a clinical program and trials portfolio.
• Lead cross-functional teams; drive program planning, governance, and regulatory interactions.
• Act as escalation point for issues; promote cross-functional solutions.
• Maximize operational feasibility and efficiency across the portfolio.
• Ensure consistency and quality across assigned programs and portfolio.
• Support resource planning and staffing; supervise clinical scientists and study managers.
• Collaborate with internal/external stakeholders (KOLs, vendors) to achieve objectives.
• Assist Clinical Directors on leadership initiatives and publication preparations.
• Lead process improvements and strategic initiatives where applicable.
• Provide guidance to team members on deliverables and TA/program requirements.

Skills

Clinical Leadership

Clinical Programs

Clinical Strategy

Clinical Trials Operations

Coaching

Cross-Functional Leadership

GCP

Immunology

People Management

Program Management

Project Management

Scientific Leadership

Stakeholder Communications

Vendor Oversight

Education

Bachelor’s degree + 12 years

Master’s + 9 years

PhD/PharmD + 6 years

Tools

Advanced computer/database skills

Job description

Job Description

Looking for an experienced Program Lead for our exciting Tulisokibart asset. This position provides oversight and leadership of clinical program execution for our Tulisokibart IBD program. 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.

Core Responsibilities

• Responsible and accountable for the operational execution of a suite of clinical trials encompassing a clinical program.
• Lead and direct teams to support key program planning and execution elements (e.g., program level overviews; sr. management, and governance meetings; regulatory agency interactions; advisory meeting preparation).
• Serves as an escalation point for issues and promotes cross-function solutions.
• Leads efforts to maximize operational feasibility and efficiency.
• Ensure consistency and quality across assigned portfolio.
• Serve as the operational representative on the Product Development’s Clinical Subteam.
• Contributes to resource planning and staffing (hiring and/or project onboarding, supervision of clinical scientists and study managers).
• Collaborate and facilitate interactions with key internal and external stakeholders (e.g., KOLs, supplies) in support of clinical program objectives.
• Assist the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations.
• May lead and/or implement process improvement and strategic initiatives.
• Management of direct reports including professional development and performance management.

Core Skills

• Demonstrated ability to drive and manage clinical program(s) (e.g., strategic planning through post-approval).
• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division.
• Interact with key stakeholders across department, division, and company.
• Role requires proactive approach, strategic thinking, and leadership to envision, plan and execute organizational goals.
• Makes decisions guided by profit plan or budget that impact support, resourcing and implementation of projects, programs and/or technologies.
• Demonstrated ability to effectively delegate work to meet the business needs.
• Resolves complex technical, operational, and financial problems.
• Decisions guided by resource availability and department objectives.
• Ability to take a broader view of issues to maximize benefit and/or impact to the organization.
• Has strong understanding of end-to-end clinical research process.
• Excellent writing and communication skills.
• Demonstrated leadership skills in supervising people, managing programs & processes, leading meetings and/or influencing peers and direct reports in a matrix environment.
• Problem solving, conflict resolution, and critical thinking skills.
• Expert knowledge of GCP and ICH regulations.
• Demonstrated project management, and time management/organizational skills.
• Build team capabilities through proactive coaching.
• Provide guidance to team members/colleagues for functional area deliverables with emphasis on consistent application of Therapeutic Area or program specific requirements.
• Strong communication skills with advanced oral and written English skills.
• Advanced computer/database skills.
• Experience Bachelor’s degree + 12 years -OR- Master’s + 9 years -OR- PhD/PharmD + 6 years Pharmaceutical and/or clinical drug development experience. Degree in life sciences, preferred.

Ideal candidate would have:

• Highly preferred: Experience in conducting global clinical trials programs, including product planning through initial filing in Gastroenterology, Dermatology, or Rheumatology, especially autoimmune or immune-mediated disorders (e.g., ulcerative colitis, Crohn's disease, rheumatoid arthritis, hidradenitis suppurative, atopic dermatitis, etc.).
• Managing direct reports.
• Candidates with the following experiences/expertise are highly preferred, but not required:
  • Experience in conducting clinical trials in gastrointestinal, preferably autoimmune and/or immune mediated disease trials.
  • Experience with selecting and utilizing programmatic vendors, including but not limited to imaging, histopathology, electronic clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee.
  • Experience in developing protocols and study related documents for Immunology related clinical trials.

Required Skills

• Clinical Leadership
• Clinical Programs
• Clinical Strategy
• Clinical Trials Operations
• Coaching
• Cross-Functional Leadership
• Good Clinical Practice (GCP)
• Immunology
• People Management
• Program Management
• Project Management
• Scientific Leadership
• Stakeholder Communications
• Vendor Oversight

Preferred Skills

• 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.

Equal Employment Opportunity Statement

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.

Salary and Benefits

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.

• Medical
• Dental
• Vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days

Other 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

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: 10%

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): N/A

Job Posting End Date: 09/30/2026

*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.

Company Overview

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.