Senior Manager/Director, Clinical Operations

Lycia Therapeutics

Senior Manager/Director overseeing clinical operations for Lycia Therapeutics clinical trials. Collaborating with CROs to manage early phase clinical programs with an emphasis on strategic planning and regulatory compliance.

Posted 7/17/2026full-timeSouth San Francisco • California • 🇺🇸 United StatesSenior💰 $180,000 - $250,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical operations management, including strategic planning, compliance with FDA regulations, and oversight of clinical study finances. Proven ability to build and lead teams, develop relationships with vendors, and enhance operational efficiency in the pharmaceutical and biotech sectors.

Highest-signal resume keywords

Clinical Operations ManagementFDA Regulations ComplianceTeam Leadership and DevelopmentFinancial Tracking and AnalysisContract Research Organization Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Operational Strategic PlanningStudy Feasibility DevelopmentCost EstimationSOP DevelopmentICH GCP Guidelines KnowledgeClinical Program Financial TrackingVendor Invoice Review and ApprovalResource AllocationContract ManagementClinical Literature Familiarity

Soft Skills

Collaborative Team PlayerDynamic Interpersonal ApproachInfluencing Strategic DirectionConsensus ManagementEffective Communication

Certifications & Qualifications

B.A/B.S RequiredM.S., PhD, PharmD, MD Preferred

Industry Keywords

Pharmaceutical IndustryBiotech IndustryClinical OperationsContract Research OrganizationsInvestigative SitesClinical Study ManagementOperational EfficiencyVendor ManagementTherapeutic Area KnowledgePharmaceutical Regulations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Create and execute clinical operational strategic plans in line with product strategy and resource allocation.
Develop study feasibility, cost estimates, input into contracts, work/change orders and analyze tools and processes to support outsourcing efforts.
Track clinical program study finances and monthly accruals and review/approve associated clinical site and vendor invoices.
Build, develop and train internal staff and external vendors, structure department for enhancing efficiency, and create a highly engaged work environment for attracting and retaining highly qualified clinical operations professionals.
Develop and ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines.
Oversee and maintain the relationships with Contract Research Organizations, vendors, and investigative sites.
Participate on clinical operations and study team meetings.
Maintain a high level of professional expertise through familiarity of clinical literature, knowledge of therapeutic area, current medical practice and pharmaceutical regulations.

Requirements

What you’ll need

B.A/B.S required; M.S., PhD, PharmD, MD or other related advanced scientific degree strongly preferred.
Minimum of 7 years for manager and 12 years for director level with progressive advancement within clinical operations in the pharmaceutical/biotech industry.
Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers, and staff.
Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global clinical operations issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.

Benefits

Comp & perks

Annual bonus
Equity
Generous benefits package