Sr. Principal Scientist, Clinical Operations Immunology Lead Full-time

Immunology Clinical Operations Lead

Translational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof-of-concept and advance the most promising candidates through the pipeline to patients. Our Clinical and Operations organization designs and executes clinical pharmacology strategies spanning first-in-human studies through proof-of-biology/proof-of-concept and into late-stage development, supporting worldwide marketing applications and lifecycle management.

In a competitive external landscape and fast-paced internal environment, the Immunology Clinical Operations Lead position provides both strategic and operational leadership across early immunology programs, ensuring timely, high-quality execution of clinical studies and clinical pharmacology strategies worldwide. The successful candidate will telescope between strategy and hands-on execution across a portfolio of diverse modalities (e.g. peptides, small molecules, biologics), and partner cross-functionally to develop the needed expertise to successfully advance programs to key inflection points in development. This role is equivalent in level to a Senior Director position.

Why Join Us:

• Take a clinical operations leadership role at the intersection of discovery and clinical development to advance novel immunology therapeutics from bench to bedside.
• Influence strategy, build teams, and deliver high-impact clinical programs that shape the future of patient care.

Key Responsibilities:

• Co-own and execute the early clinical development strategy for the immunology portfolio with the Head of TMed Immunology
• Provide comprehensive strategic planning and operational oversight for immunology clinical programs and trials to maximize operational feasibility, efficiency, and ensure consistency and quality across the portfolio
• Build global network of immunology sites and foster relationships with key investigators for Ph1b/2a patient trials to deliver on clinical program goals
• Serve as the deep subject matter expert and issue escalation point for early immunology clinical operations
• Ensure appropriate resources, competencies, and partnerships are in place to meet objectives
• Critically review strategy and clinical program documents (development plans, investigator's brochures, protocols, etc.), providing scientific and operational insight to ensure best path forward
• Partner with Business Development and Licensing to evaluate internal and external opportunities that align with portfolio strategy
• Actively participate in annual and quarterly planning cycles: identify risks, develop and execute mitigation plans, and track performance metrics and outcomes
• Ensure immunology data integrity across organization (Book of Business, CTMS, etc.)
• Build and sustain strong cross-functional relationships (country operations, clinical supplies, data management, regulatory, etc.) across departments, divisions, and geographies
• Foster the people pipeline: Attract, coach, mentor, and retain talent; provide performance management support; act as 'player-coach' to enrich group skillsets. Potential for people management.
• Represent TMed on enterprise strategic initiatives and lead continuous-improvement efforts that increase clinical efficiency and scientific impact
• Serve as a member of the TMed Clinical Operations leadership team and contribute to shaping department strategy

Education Requirement

• Degree in Life Sciences with one of the following experience combinations:
• Bachelor's degree + ≥16 years related experience, OR
• Master's degree + ≥15 years related experience, OR
• PhD/PharmD + ≥12 years related experience
• Related Experience Includes: pharmaceutical industry roles in clinical drug development, clinical trial management, clinical site monitoring/training, medical/regulatory writing, or translational science

Required Experience and Skills

• Extensive clinical operations experience in the planning and execution of early clinical development trials (Phase 1 and early proof-of-concept)
• Demonstrated ability to translate knowledge to other areas to effectively collaborate, network, and influence peers, senior leaders, and external partners
• Proven track record building and leading high-performing cross-functional teams in a matrixed environment
• Strong decision-making skills, weighing advantages, disadvantages, and business impact for rapid decisions and proven track record delivering results on firm deadlines
• Ability to work successfully with ambiguity and embrace uncertainty
• Strong oral and written communication skills
• Experience attracting, developing, and retaining talent

Preferred Experience and Skills

• Experience leading clinical programs and trials for gastroenterology, dermatology, and/or rheumatology, especially autoimmune or immune-mediated disorders, including in both large and small pharma contexts
• Familiarity with broader pharmaceutical industry considerations and trends beyond clinical development

Required Skills:

Clinical Development, Clinical Research, Clinical Studies, Clinical Trial Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Operations, Cross-Cultural Awareness, Cross-Functional Teamwork, Drug Development, Early Clinical Development, Early Phase Clinical Trials, Ethical Compliance, Ethical Standards, External Partners, Mentorship, Operational Leadership, Professional Networking, Protocol Development, Translational Medicine

Preferred Skills:

Salary Range for this role is $210,400.00 – $331,100.00

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.

You can apply for this role through https://jobs.merck.com/us/en (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

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