Sutro CRO Partners: Exciting Opportunity for a Global Clinical Trial Leader

Are you an energetic and talented individual with a passion for drug development? Sutro Biopharma, Inc., a leader in next-generation oncology therapeutics, is seeking a highly motivated Global Clinical Trial Leader to join our dynamic research and development team. This is an exceptional opportunity to contribute to cutting-edge clinical trials and work collaboratively with Sutro’s CRO partners to advance innovative cancer treatments.

At Sutro Biopharma, we are committed to transforming the lives of cancer patients. We leverage precise protein engineering and rational design to develop groundbreaking therapies. Our collaborative approach extends to our valuable CRO partners, ensuring seamless and efficient clinical trial execution. As a Global Clinical Trial Leader, you will play a pivotal role in managing these crucial partnerships and driving our clinical programs forward.

This position, based at our headquarters in South San Francisco, offers a fast-paced and stimulating environment where you will be instrumental in maximizing our technology and enhancing both internal and collaborative product development initiatives. If you are a strategic thinker with a strong operational background in clinical trials and experience working with CROs, we encourage you to apply.

Responsibilities of a Global Clinical Trial Leader at Sutro

As a Global Clinical Trial Leader at Sutro, you will be at the forefront of our clinical operations, providing both strategic and operational leadership to one or more study teams. Your primary responsibility will be to ensure that study milestones are achieved on time, within budget, and to the highest quality standards, all while adhering to ICH/GCP guidelines and relevant regulations. A key aspect of this role involves close collaboration with Sutro Cro Partners to effectively manage and oversee outsourced clinical trial activities.

Your key responsibilities will include:

Strategic Leadership and Direction: Provide clear leadership and direction to study teams, ensuring all cross-functional activities align with the clinical development plan. This involves setting a clear vision and fostering a collaborative environment with both internal teams and Sutro CRO partners.
Tactical Implementation and Management: Accountable for the tactical execution of the clinical development plan. This includes meticulous management of study timelines, resources, and budgets from study start-up through to Clinical Study Report finalization. Efficiently manage the day-to-day interactions and deliverables from Sutro CRO partners involved in the study.
Operational Strategy and Feasibility: Lead the development of the operational strategy, including site and country feasibility assessments in close partnership with the CRO. Your expertise will be crucial in finalizing country and site selection, leveraging insights from Sutro CRO partners and internal stakeholders.
Milestone and Timeline Management: Drive the establishment of study milestones and timelines, proactively monitoring progress and ensuring adherence. Regularly communicate progress and potential roadblocks to management and to Sutro CRO partners, facilitating proactive problem-solving.
Team Building and Performance: Build and maintain high-performing study teams by clearly defining roles, responsibilities, accountabilities, and deliverables for all team members, including those from Sutro CRO partners.
Core Study Document Development: Ensure all relevant functions contribute to the development and finalization of core study documents such as protocols, ICFs, and eCRFs. This requires effective coordination with Sutro CRO partners to ensure alignment and compliance.
Meeting Organization and Leadership: Organize and lead study team meetings with the CRO, involving all relevant internal and external stakeholders. Facilitate kick-off meetings with CROs and vendors, ensuring clear communication and expectations from the outset.
Issue and Risk Escalation and Resolution: Ensure timely escalation of issues and risks that could significantly impact study timelines, budget, or quality to management. Proactively work with Sutro CRO partners to develop and implement effective resolution strategies.
CRO and Vendor Selection and Management: Participate in or be accountable for the selection process of CROs and vendors for assigned studies. This includes defining scope of work, evaluating proposals, and ensuring alignment with Sutro’s strategic objectives.
Budget Development and Contract Negotiation: Accountable for developing study budgets and managing contract negotiations with vendors in partnership with Legal and Finance. This requires a keen understanding of CRO and vendor pricing models and negotiation strategies to ensure cost-effective partnerships.
Oversight of Outsourced Activities: Provide direction and rigorous oversight of outsourced activities to ensure CRO and vendor delivery against contracted scope of work. This includes proactive monitoring of performance metrics and regular communication to address any deviations.
Budget Forecasting and Variance Management: Accountable for accurate study budget forecasting and actively manage variances between actual and planned spend. Regularly review financial reports from Sutro CRO partners and internal finance teams to maintain budgetary control.
Progress Reporting and Communication: Provide management with timely and comprehensive updates on study progress and any changes in scope, schedule, and resources. Maintain transparent communication channels with Sutro CRO partners and internal stakeholders.
Invoice Review and Payment Processing: Review and approve invoices, manage monthly accruals, and ensure timely payment processing for vendors, including investigative sites (as applicable). Work closely with finance and Sutro CRO partners to streamline invoice and payment processes.
Patient Recruitment Strategies: Responsible for the development and execution of effective patient recruitment strategies, collaborating with sites and Sutro CRO partners to optimize enrollment.
Investigational Product Supply: Work closely with Drug Supply to ensure investigational product requirements for the studies are met, coordinating with Sutro CRO partners on logistics and distribution as needed.
Study Quality and GCP Compliance: Ensure ongoing review of study quality, raising issues as appropriate and ensuring resolution. Work collaboratively with other functions and Sutro CRO partners to maintain GCP compliance and inspection readiness throughout the study lifecycle.
Lessons Learned and Process Improvement: Incorporate learnings and recommendations from previous studies to continuously improve clinical operations processes. Contribute to establishing or improving clinical operations processes and the implementation of systems, and participate in the review of SOPs.
Sponsor Oversight Visits: Conduct Sponsor Oversight visits to assess sites and CRAs in adherence to study plans, protocol, and GCP as needed, ensuring quality and compliance at all study sites and within Sutro CRO partners.
Line Management Capabilities: For those with direct reports, provide guidance, performance development, coaching, and mentoring. Conduct ongoing performance management conversations and ensure direct reports are appropriately trained, developed, and coached in company and regulatory standards.
Organizational Change Leadership: Drive and/or support changes within the organization, contributing to a culture of continuous improvement and adaptation within clinical operations and in collaboration with Sutro CRO partners.

Skills Needed to Thrive

To excel as a Global Clinical Trial Leader at Sutro and effectively manage Sutro CRO partners, you will need to demonstrate the following skills:

Strong Leadership and Motivational Skills: Proven ability to effectively lead study teams, including CRO personnel, to achieve established goals within expected timeframes.
Critical Thinking and Efficiency Focus: Applies critical thinking to simplify work processes and strives for efficiency in all aspects of clinical trial management, including interactions with Sutro CRO partners.
Influence, Negotiation, and Conflict Management: Ability to effectively influence, negotiate, and manage conflicts, both internally and externally with Sutro CRO partners and vendors.
Strong Organizational and Prioritization Skills: Exceptional organizational skills and the ability to prioritize tasks and work independently, adapting to changing priorities in a fast-paced environment.
Strategic Thinking and Problem-Solving Mindset: Possesses strategic thinking skills with the ability to proactively identify risks and a strong problem-solving mindset to address challenges effectively, including those related to Sutro CRO partners.
Exceptional Communication and Stakeholder Management: Exceptional verbal and written communication skills and strong stakeholder management skills, crucial for effective interaction with cross-functional teams, management, investigators, study coordinators, and Sutro CRO partners.
Cross-Functional Collaboration: Able to operate and cooperate effectively at all levels within a project, from oversight to hands-on management of day-to-day activities, fostering strong collaborative relationships with Sutro CRO partners.

Qualifications to Join Sutro’s Team

To be considered for this exciting opportunity, candidates should possess the following qualifications:

Educational Background: Bachelors/Master’s degree (or equivalent) in a health care or other scientifically related discipline is required.
Industry Experience: 7+ years of related industry experience as a CRA/Manager or related function with increasing responsibility and scope, including significant experience managing global clinical trials and CRO interactions.
Oncology Trial Expertise: Previous experience in the management of Global Oncology clinical trials (early phase is a plus) is highly desirable, showcasing familiarity with the specific challenges and complexities of oncology drug development.
Monitoring Experience: 2+ years monitoring experience, ideally with a mix of CRO and biopharmaceutical experience, providing a well-rounded understanding of clinical trial operations from both sponsor and CRO perspectives.
Drug Development Process Knowledge: Strong knowledge and experience of the drug development process, with a working knowledge of details and issues involved in different functional areas (i.e., data management, pharmacovigilance, regulatory, biostats, etc.).
CRO and Vendor Management Expertise: Demonstrated experience in selecting, managing, and overseeing CROs and multiple vendors, and managing complex study budgets, highlighting the ability to effectively handle Sutro CRO partners.
Motivation and Adaptability: Highly motivated and thrives in a fast-paced environment, achievement-driven, and able to adapt to the dynamic nature of clinical research and Sutro CRO partner collaborations.
Regulatory and GCP Knowledge: Thorough understanding of ICH/GCP guidelines and knowledge of regulatory requirements (e.g., ICH/CFR guidelines; FDA Diversity Guidance).
Computer Proficiency: Computer proficiency in standard office software (Outlook, MS Word, Excel, and PowerPoint).
Willingness to Travel: Willingness to travel as necessary, consistent with project needs, including potential travel to CRO sites or investigator meetings.
Vaccination Requirement: Sutro Biopharma, Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment, with consideration for reasonable accommodations as required by applicable law.

Sutro Biopharma: A Leader in Oncology and CRO Partnerships

Sutro Biopharma, Inc. is not just developing groundbreaking oncology therapeutics; we are also building strong, strategic partnerships with leading Contract Research Organizations (CROs). We recognize the critical role that Sutro CRO partners play in the successful execution of our clinical trials. By fostering collaborative and transparent relationships with our CROs, we ensure efficiency, quality, and innovation in our clinical programs.

Our commitment to our partners extends beyond project-specific collaborations. We view Sutro CRO partners as integral to our extended team, working together to accelerate the development of life-changing medicines for cancer patients. Joining Sutro means becoming part of a company that values collaboration, innovation, and a shared dedication to making a difference in the fight against cancer.

Apply Today and Join Our Team!

If you are a driven and experienced clinical trial leader seeking a challenging and rewarding opportunity to work at the forefront of oncology drug development and manage key Sutro CRO partners, we encourage you to apply. Be a part of Sutro Biopharma’s mission to transform the lives of cancer patients.

Please submit your resume for Req. # 23-700-003A to [email protected]. Visit our website at www.sutrobio.com to learn more about Sutro Biopharma and our collaborative culture.

Sutro Biopharma offers a competitive benefits package and is an equal opportunity employer committed to fostering a diverse and inclusive workplace.

The anticipated salary range for this role in our California locations is $215,000 – $245,000 (not including bonus, equity, and benefits). The final salary will be determined based on factors such as relevant experience, job responsibilities, and education.

We look forward to hearing from exceptional candidates who are eager to explore opportunities with Sutro!