Translational Medicine Clinical Operations Immunology Therapeutic Area Lead (Prin. Scientist)

Merck & Co.

USA - Massachusetts - Boston (MA Parcel B Laboratory) +3 more Onsite Clinical Research

About this role

Job Description

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. We design and execute 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, this 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.

Why join us:

Take a 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 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 ensure efficient, timely execution against milestones
Ensure appropriate resources, competencies, and partnerships are in place to meet objectives
Serve as the deep subject matter expert for early immunology clinical operations
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 program efficiency and scientific impact 
Serve as a member of the TMed U.S. 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 + ≥12 years related experience, OR
Master’s degree + ≥10 years related experience, OR
Ph.D. or doctorate +≥8 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

Proven track record building and leading high-performing cross-functional teams in a matrixed environment
Deep knowledge of early clinical development (Phase 1 and early proof-of-concept)
Demonstrated ability to collaborate, network, and influence peers, senior leaders, and external partners
Strong oral and written communication skills
Track record delivering results on firm deadlines
Strong decision-making skills, weighing advantages, disadvantages, and business impact for rapid decisions
Ability to work successfully with ambiguity and embrace uncertainty
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

#EligibleforERP

Required Skills:

Clinical Development, Clinical Study Design, Clinical Trial Development, Clinical Trial Management, Clinical Trials, Clinical Trials Operations, Cross-Functional Collaboration, Ethical Compliance, Ethical Standards, Immunology, Stakeholder Engagement

Preferred Skills:

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Current Contingent Workers apply HERE

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