Remote Senior Director, Clinical Operations

Lyciatherapeutics; South San Francisco (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Lycia Therapeutics seeks a Senior Manager/Director of Clinical Operations to oversee up to two early-phase programs, collaborating with a CRO partner. You will craft strategic operational plans and manage budgets, vendors, and staff while ensuring ICH GCP and FDA compliance.

The role emphasizes leadership, cross-functional teamwork, and continuous process improvement in a fast-paced biotech environment, with remote work and periodic site visits.

Qualifications

• Minimum of 7 years for manager and 12 years for director level with progressive advancement within clinical operations in the pharmaceutical/biotech industry.
• B.A./B.S. required; advanced degree strongly preferred (MS/PhD/PharmD/MD).
• Demonstrated ability to influence strategic direction in global clinical operations and work cross-functionally.

Responsibilities

• Create and execute clinical operational strategic plans in line with product strategy and resource allocation.
• Develop study feasibility, cost estimates, input into contracts, and support outsourcing efforts.
• Track study finances and accruals; review/approve associated site and vendor invoices.
• Build, develop and train internal staff and external vendors; structure department for efficiency and engagement.
• Develop and ensure SOPs and guidelines; ensure FDA and current ICH GCP compliance.
• Oversee relationships with CROs, vendors, and investigative sites.
• Participate in clinical operations and study team meetings.
• Maintain professional expertise through familiarity with literature, therapeutic area, and regulations.

Skills

Clinical operations

Vendor management

Program management

Cross-functional leadership

FDA regulations

ICH GCP

Education

B.A./B.S. required

MS/PhD/PharmD/MD preferred

Job description

Lycia Therapeutics seeks a Senior Manager/Director of Clinical Operations to oversee up to two early-phase programs, collaborating with a CRO partner. You will craft strategic operational plans and manage budgets, vendors, and staff while ensuring ICH GCP and FDA compliance.

The role emphasizes leadership, cross-functional teamwork, and continuous process improvement in a fast-paced biotech environment, with remote work and periodic site visits.