Clinical Trial Leader

Description:

Working Model: Hybrid, South San Francisco, CA (three days onsite, two days remote - Tuesdays and Thursdays are anchor days)

Working Days: Monday through Friday

Working Hours: Standard eight (8 AM to 4 PM or 9 AM to 5 PM PT)

Interview Format: Two Rounds (1 - hiring manager phone screening [20 minutes]; 2 - Panel [on-site - 1 hour 30 minutes - where the candidates will interview with the panel for 45 minutes, then move into another meeting with a manager for the remaining 45 minutes])

Responsibilities:

Research and Early Development (gRED)

The gRED Global Clinical Trial Leader (CTL) is accountable for the execution and delivery of early development global clinical trials under the leadership of the Sr. CTL. These complex programs focus on the rapid development of new molecular entities with limited or no clinical data, requiring the implementation of Client and highly flexible global operational strategies.

The CTL actively contributes to the Protocol Execution Team (PET), manages vendors, develops risk mitigation strategies, and champions change related to study assignments and department goals.

Role & Key Responsibilities:

Study Execution & Team Collaboration :

Operational Expertise: Provide operational guidance to one or more global cross-functional Protocol Execution Teams (PETs) across all study stages (start-up, conduct, and close-out).

Culture & Leadership: Foster a positive work environment built on mutual respect, innovation, and accountability at both local and global project levels.

Trial Documentation: Drive and finalize cross-functional activities ensuring the quality delivery of vendor specifications, drug supply forecasting, monitoring/communication plans, Trial Master Files (TMF), and CTMS data.

Stakeholder Alignment : Collaborate with cross-functional members on study plans and coordinate effective investigator meetings.

Vendor & Budget Management:

Vendor Oversight: Participate in vendor selection alongside the PETL; oversee outsourced activities to ensure CROs and vendors deliver strictly aProductst contracted Products of work.

Financial Input: Provide strategic input into the overall study budget and directly manage assigned vendor budgets.

Strategic Planning & Strategy:

Feasibility & Design: Contribute to country and site selection, assist in developing clinical trial protocols/informed consents, and provide operational input on protocol feasibility.

Risk & Timeline Management : Apply critical thinking to manage timelines, identify bottlenecks, and propose actionable resolutions.

Patient Centricity: Maintain a patient and site-centric mindset across all trial activities and interactions.

Contributing to the Wider gRED Community:

Process Improvement: Partner with gRED and pan-Client colleagues to establish operational best practices and enhance clinical trial execution across the organization.

Subject Matter Expertise: Serve as a Subject Matter Expert (SME) or gRED single point of contact for Cliented functional initiatives.

Mentorship: Coach, mentor, and share expertise to support the development of junior staff and peers.

Experience, Skills & Attributes:

Core Philosophy: A successful candidate is a developing leader who exhibits a high degree of curiosity, a growth mindset, and a strong customer focus where the patient is always the ultimate customer.

Technical & Professional Experience

Early Phase Expertise: Proven experience managing delegated aspects of global, complex Phase I and II clinical studies.

Vendor Management: Demonstrated success effectively managing a diverse portfolio of vendors and CROs.

Risk & Strategy: Adept at identifying, assessing, and proactively mitigating operational risks using quantitative and qualitative data.

Leadership & Soft Skills:

Communication & Influence: Excellent communication skills with the ability to independently deliver key messages to stakeholders, influence teams, and negotiate to achieve shared goals.

Problem Solving: Creative problem solver who welcomes diversity of thought to navigate through ambiguity and resolve issues.

Adaptability: Highly flexible, solution-focused, and self-aware, exercising excellent judgment on when to seek guidance.

Change Champion: Consistently advocates for and supports organizational change to positively impact the business.

Qualifications & Requirements:

Education: Bachelor’s degree or equivalent required (scientific or healthcare discipline preferred).

Experience: 8+ years of clinical study management experience desired.

Knowledge: Working knowledge of GCP/ICH requirements, international regulatory guidelines, and the end to end drug development process.

Travel: Some travel may be required.