Sr. Principal Scientist, Clinical Operations Immunology Lead
Merck · Rahway, NJ · 1 wk ago
Research$210k–$331k/yrFull-time
About the role
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.
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
- 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
- Participate actively 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
- 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
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
- Prominent 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
- Able to work successfully with ambiguity and embrace uncertainty
- Strong oral and written communication skills
- Experience attracting, developing, and retaining talent
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
- Prominent 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
- Able to work successfully with ambiguity and embrace uncertainty
- Strong oral and written communication skills
- Experience attracting, developing, and retaining talent