Sr. Principal Scientist, Clinical Operations Immunology Lead

Merck • Boston, MA

5d • $210,400 - $331,100 • Hybrid

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

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

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior