Vice President, Clinical Operations jobs in United States
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TCG Labs Soleil · 2 months ago

Vice President, Clinical Operations

TCG Labs Soleil is pioneering a novel ‘venture capital-biotech’ model focused on developing therapeutic solutions for serious diseases. The Vice President of Clinical Operations will oversee clinical operations, ensuring timely execution of clinical trials while providing expertise to cross-functional teams in a high-growth environment.

Biotechnology

Responsibilities

Accountable for maintaining oversight of clinical programs to ensure timely and high-quality study execution, data generation and analysis to support regulatory filings
Accountable for delivering on clinical operations scenario planning, high level forecasting of timelines, assessment of program level feasibility
Accountable for ensuring resource availability to maintain inspection-readiness across clinical programs
Accountable for preparing and presenting trial parameters and clinical information to executive leadership, vendors, and other key stakeholders
Responsible for identification, prioritization, and definition of new processes and systems to support organizational growth
Responsible for developing hiring and retention strategies to ensure appropriate resourcing across Clinical Operations
Responsible for providing input, as needed, for clinical and regulatory documents

Qualification

Clinical trial managementDrug development processICHGCP guidelinesLeadershipRare disease experienceOrganizational skillsTeam-buildingEffective communicationProblem-solvingCritical thinking

Required

Bachelor's degree required
At least 15 years of experience working with clinical research organization to manage global clinical trials
At least 10 years experience managing direct report, evidencing strong leadership, team-building, and hands on management
Demonstrated ability to build high-functioning teams that can adapt to changing priorities
Demonstrated knowledge of the drug development process in the bio/pharmaceutical industry with an understanding of relevant regulatory requirements
Comprehensive understanding of ICH and GCP guidelines, as well as applicable regulations and practices
Excellent organizational skills and attention to detail
Effective communication and interpersonal skills
Able to set priorities and juggle multiple demands
Able to think critically, diagnose root causes and be a proactive problem-solver
Able to work independently while exercising initiative, flexibility and sound judgment
Comfortable working with different levels of the company including senior level management

Preferred

Higher degrees in life sciences preferred
Rare disease experience is a plus

Benefits

Medical, Dental, and Vision Insurance
Life Insurance
Short and Long Term Disability
Health Savings Account (HSA)
Flexible Spending Accounts (FSA)
401k plan
PTO

Company

TCG Labs Soleil

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At TCG Labs Soleil, we are establishing a pioneering venture-biotech model in collaboration with The Column Group.

Funding

Current Stage
Early Stage

Leadership Team

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Jin-Long Chen
Managing Partner, TCG Labs | Co-Founder and Chief Executive Officer, Soleil
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Harding Luan
VP, Discovery Research and Co-Founder
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Company data provided by crunchbase