Director, Program Lead - Immunology

Merck; North Wales (Montgomery County); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck is seeking an experienced Program Lead to oversee and guide clinical program execution for the Tulisokibart IBD program. You will lead global, cross-functional teams from strategic planning through post-marketing approval, applying project management and leadership to advance development in a fast-paced bio-pharma setting.

The ideal candidate has extensive experience in global clinical trials, strong GCP/ICH knowledge, and proven leadership in matrix environments.

Qualifications

• Bachelor’s degree with 12+ years or Master’s with 9+ years or PhD/PharmD with 6+ years of pharmaceutical/clinical drug development experience.
• Experience leading global clinical trials programs and cross-functional teams.
• Strong knowledge of GCP and ICH regulations; excellent communication skills.

Responsibilities

• Oversee operation of a suite of clinical trials within a clinical program.
• Lead and direct teams for program planning and execution including governance and regulatory interactions.
• Maximize operational feasibility and efficiency, ensuring consistency and quality across the portfolio.

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 in life sciences

Master’s degree or PhD/PharmD in life sciences

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).

This Includes The Ability To

• 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 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

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.

Requirements

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

Salary Range

$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 https://jobs.merck.com/us/en/compensation-and-benefits.

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.

Requisition ID

R407665