About this role
This Principal Scientist role provides oversight and leadership for end-to-end clinical program execution. The position leads global, cross-functional teams to drive operational feasibility, execution quality, and stakeholder/regulatory engagement across the full clinical development lifecycle.
Key Responsibilities
- Oversee operational execution of clinical trials within a clinical program
- Lead teams supporting program planning elements including governance meetings and regulatory interactions
- Maximize operational feasibility and efficiency across the portfolio
- Act as the operational representative on Product Development's Clinical Subteam
- Support scientific leadership initiatives including publications and meeting presentations
Technical Overview
The role is clinical operations-focused rather than software engineering, centering on operational execution, governance meeting support, regulatory agency interactions, and advisory meeting preparation. It requires strong understanding of the end-to-end clinical research process and the ability to drive cross-functional program planning through post-approval.
Ideal Candidate
The ideal candidate is a senior clinical operations scientist who can oversee and lead clinical program execution across end-to-end clinical development, from strategic planning through post-marketing approval. They have strong operational leadership experience, including managing clinical trials, aligning stakeholders (including KOLs), handling regulatory agency interactions, and preparing for advisory meetings.
Must-Have Skills
Oversight and leadership of clinical program executionOperational execution of a suite of clinical trials encompassing a clinical programAbility to drive and manage clinical program(s) (strategic planning through post-approval)Strong understanding of end-to-end clinical research processDemonstrated leadership skills in supervising peoplemanaging programs & processesleading meetings and/or influencing peers
Required Skills
clinical program executionend-to-end clinical developmentoperational execution of clinical trialsstrategic planning through post-marketing approvalprogram level overviewsgovernance meetingsregulatory agency interactionsadvisory meeting preparationoperational feasibilityoperational efficiencyresource planning and staffinghiringproject onboardingclinical scientistsstudy managersKOLs (Key Opinion Leaders)publicationsmeeting presentationsprocess improvementstakeholder managementend-to-end clinical research process
Hard Skills
end-to-end clinical development activitiesstrategic planning through post-marketing approvaloperational execution of clinical trialsclinical program execution oversightprogram level overviewsgovernance meetingsregulatory agency interactionsadvisory meeting preparationoperational feasibilityoperational efficiencyconsistency and quality across assigned portfolioProduct Development's Clinical Subteamresource planning and staffinghiring and/or project onboardingsupervision of clinical scientistsstudy managers supervisionstakeholder managementKOLs (Key Opinion Leaders) interactionsinternal and external stakeholder coordinationprocess improvement and strategic initiativesprofessional development and performance managementscientific leadership for investigator initiativespublications preparationmeeting presentationsend-to-end clinical research processwriting and communication skillsconflict resolutioncritical thinking
Soft Skills
Oversight and leadership of clinical program executionCross-functional team leadershipEscalation managementPromoting cross-function solutionsStrategic thinkingDecision-making guided by profit plan or budgetDelegationComplex problem solvingInfluencing opinions and decisions across functional areasProactive approachMeeting leadershipWriting and communicationConflict resolutionMatrix environment collaborationMentorship and supervision
Keywords for Your Resume
Principal ScientistClinical Operations Immunologyclinical program executionclinical programsuite of clinical trialsend-to-end clinical developmentstrategic planning through post-marketing approvaloperational feasibilityoperational efficiencyprogram level overviewsgovernance meetingsregulatory agency interactionsadvisory meeting preparationProduct Development's Clinical Subteamresource planning and staffinghiringproject onboardingclinical scientistsstudy managersKOLs (Key Opinion Leaders)publicationsmeeting presentationsprocess improvementstakeholder managementend-to-end clinical research processmatrix environmentoperational execution of clinical trials
Deal Breakers
Must demonstrate oversight and operational execution of a clinical program and a suite of clinical trials, Must have a strong understanding of the end-to-end clinical research process
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