Senior Principal Scientist, Clinical Operations – Immunology Lead
Boston, New Jersey, United States of America
Full Time
4 hours ago
$210,400 - $331,100 USD
Visa Sponsor
Key skills
LeadershipStrategic PlanningCommunication
About this role
Role Overview
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
Requirements
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
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.
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)