Sr / Clinical Program Manager

Location: Remote (EST)

About the role

The 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.

Responsibilities

• Provide 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 Knowledge

• Bachelor’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.