Global Clinical Trial Leader (South San Francisco, CA)
Sutro Biopharma, Inc. is looking for energetic and talented individuals to join its multidisciplinary research and development team. You will be working to develop new processes to maximize our technology and enhance our internal and collaborative product development initiatives in a fast paced environment.
The Global Clinical Trial Leader leads one or more study teams and provides strategic and operational leadership to ensure the study milestones are delivered on time, within budget, with high quality, and in compliance with ICH/GCP and applicable regulations. The Global Clinical Trial Leader provides input or establishes new processes, work instructions, and SOPs to ensure consistent, effective, and efficient execution of clinical operations activities across the department. This position is located at Sutro’s headquarters in South San Francisco.
- Provides leadership and direction to one or more study teams to ensure delivery of all cross functional activities in line with the clinical development plan
- Accountable for the tactical implementation of the clinical development plan by managing the timeline, resources, and budget of clinical activities within a study from start-up to Clinical Study Report finalization
- Responsible for development of the Operational Strategy; leads development of site/country feasibility in partnership with the CRO and finalizes country/site selection with input from management
- Drives setting of study milestones and timelines and monitors progress
- Builds and maintains high performing study teams by ensuring clarity of roles, responsibilities, accountabilities, and deliverables for all team members
- Ensures all relevant functions provide input to develop and finalize core study documents including protocol, ICF, eCRF
- Organizes and (co-)leads study team meetings with the CRO involving all relevant functions and internal/external stakeholders. Organizes CRO and vendor kick-off meetings.
- Ensures timely escalation of issues and risks that significantly affect study timelines, budget or quality to management and follows through till resolution
- Participates in or accountable for the selection process of CROs and vendors for assigned studies
- Accountable for developing study budgets and contract negotiations with vendors in partnership with Legal and Finance
- Provides direction and oversight of outsourced activities to ensure CRO and vendor delivery against contracted scope of work
- Accountable for accurate study budget forecasting and manages variance between actual and planned spend.
- Provides management with timely updates on progress and changes in scope, schedule, and resources within a study(ies), as applicable
- Reviews/approves invoices, manage monthly accruals, and ensures timely payment processing for vendors including investigative sites (as applicable)
- Responsible for development and execution of patient recruitment strategies
- Works closely with Drug supply to ensure investigational product requirements for the studies are met.
- Ensures ongoing review of study quality, raises issues as appropriate and ensures resolution
- Works with other functions to ensure GCP compliance and inspection readiness is maintained throughout the study
- Incorporates learnings and recommendations from lessons-learned from other studies
- Conducts Sponsor Oversight visits to assess sites/CRAs in adherence to study plans, protocol, and GCP as needed
- Line management capabilities including providing guidance, performance development, coaching and mentoring. Conduct ongoing performance management conversations with direct reports.
- Ensures direct reports are appropriately trained, developed and coached to comply with company and regulatory standards
- Leads or contributes to establishing or improving clinical operations processes and implementation of systems; Develops or contributes to the review of SOPs.
- Drives and/or supports changes within the organization.
- Strong leadership and motivational skills with demonstrated ability to effectively lead study teams to achieve the established goals within the expected time frames.
- Applies critical thinking and aims to simplify work. Strives for efficiency.
- Ability to influence, negotiate and manage conflicts.
- Strong organizational skills and the ability to prioritize and work independently and adapt to changing priorities
- Possess strategic thinking skills, ability to proactively identify risks and problem solving mindset
- Exceptional verbal and written communication skills and strong stakeholder management skills
- Able to interact cross-functionally at all levels within Sutro and externally with consultants/contractors, investigators, and study coordinators
- Ability to operate and cooperate at all levels within a project, from oversight to hands-on management of day-to-day activities
- Bachelors/Master’s degree (or equivalent) in a health care or other scientifically related discipline is required
- 7+ years of related industry experience as a CRA/Manager or related function with increasing responsibility and scope
- Previous experience in the management of Global Oncology clinical trials (early phase is a plus)
- 2+ years monitoring experience, ideally with a mix of CRO and biopharmaceutical experience
- Strong knowledge and experience of the drug development process; working knowledge of details and issues involved in different functional areas (i.e. data management, pharmacovigilance, regulatory, biostats, etc.)
- Demonstrated experience in selecting, managing, and overseeing CROs and multiple vendors and management of complex study budgets
- Highly motivated and enjoys working in a fast-paced environment; Achievement driven
- Understanding of ICH/GCP and knowledge of regulatory requirements (e.g. ICH/CFR guidelines; FDA Diversity Guidance)
- Computer proficiency (Outlook, MS Word, Excel, and PowerPoint)
- Willingness to travel as necessary, consistent with project needs
- Some travel (domestic and international), up to 15%
Sound exciting? Apply today and join our team!
Please submit resume for Req. # 23-700-003A to firstname.lastname@example.org. Please visit our website at www.sutrobio.com for more information and to learn more about how we collaborate and work together at Sutro.
Sutro Biopharma, Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Sutro will consider requests for reasonable accommodations.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $215,000 – $245,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.
The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.