Sr. Principal Scientist, Clinical Operations Immunology Lead

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. 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 prov