Sr / Clinical Program Manager

Reference: 630868Posted: 2026-09-11Location: New York, New YorkCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on us.fitly.work: Remote EST Senior Clinical Program ManagerPosition SummaryThe Senior Clinical Program Manager will provide program-level operational leadership for a new global Phase I clinical program involving conventional single ascending dose and multiple ascending dose studies.This individual will directly manage internal Clinical Trial Managers, provide program-level oversight of the CRO and external vendors, and coordinate activities across internal functions to ensure successful program execution. The ideal candidate understands how to establish an early-phase global program from the ground up and can remain hands-on within a fast-paced biotechnology environment.Specific ResponsibilitiesProvide program-level Clinical Operations leadership for a new global Phase I program.Lead the operational planning, start-up and execution of conventional SAD and MAD studies.Directly manage and provide guidance to internal Clinical Trial Managers supporting the program.Develop and maintain integrated program plans, timelines, budgets, resource plans and risk-mitigation strategies.Provide program-level oversight of the CRO, including governance, performance management and issue escalation.Lead vendor selection, contracting, oversight and performance management.Partner cross-functionally with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Medical Safety, CMC and other functions to align program activities and dependencies.Ensure studies are delivered on time, within budget and in compliance with company SOPs, study protocols, ICH-GCP requirements and applicable regulations.Anticipate operational risks, identify critical-path activities and drive issues through resolution.Support protocol development, feasibility, country and site strategy, study start-up, enrollment planning and ongoing study oversight.Prepare and communicate program-level updates, risks and recommendations to senior leadership and cross-functional governance teams.Mentor and develop Clinical Operations team members.Perform other responsibilities required to support the evolving needs of the clinical programs.Preferred Experience, Skills and KnowledgeBachelor’s degree in a scientific, healthcare or related discipline; advanced degree preferred.At least 8 years of relevant clinical research or Clinical Operations experience within biotechnology, pharmaceutical or CRO environments.At least 3 years of experience leading clinical studies or programs at the Clinical Program Manager, Senior Clinical Trial Manager or comparable level.Demonstrated experience managing global Phase I clinical trials from planning and start-up through execution.Direct experience with conventional SAD and MAD dose-escalation studies.Previous direct management of Clinical Trial Managers or other Clinical Operations personnel.Proven ability to provide program-level leadership across multiple studies, workstreams and functional dependencies.Strong CRO and vendor-management experience, including selection, contracting, governance, budgets and performance oversight.Demonstrated experience managing timelines, budgets, resources, risks and cross-functional deliverables.Experience working in a hands-on biotechnology or start-up environment.Working knowledge of FDA regulations, ICH-GCP guidelines and global clinical trial requirements.Experience with Veeva CTMS and eTMF preferred.Ophthalmology, pediatric, rare-disease and gene-therapy experience preferred?Strong leadership, communication, presentation, organizational and decision-making skills.Ability to work independently, influence cross-functional stakeholders and bring structure to a developing clinical program.