Associate Director, Clinical Operations

Sutro Biopharma, Inc.; South San Francisco (CA); On-site; USD 186,000 - 200,000; Full time

Job summary

Sutro Biopharma, Inc. is seeking an Associate Director, Clinical Operations to lead clinical operational activities for various studies. This role involves managing multi-site clinical trials, ensuring compliance with regulations, and collaborating with various stakeholders. The ideal candidate will possess strong organizational and strategic thinking skills, with a thorough understanding of clinical trial management.

Qualifications

• 15+ years of related industry experience in clinical operations.
• Experience managing global Oncology clinical trials preferred.
• Strong knowledge of FDA/EMA regulatory requirements.

Responsibilities

• Manage multi-site clinical trials involving internal and external collaborators.
• Accountable for the tactical implementation of clinical development plans.
• Ensure GCP compliance and inspection readiness throughout studies.

Skills

Problem-solving

Strategic thinking

Communication

Organizational skills

Education

Bachelor's/Master's in health care or related field

Tools

MS Word

Excel

PowerPoint

Outlook

Job description

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Position Overview:

Sutro Biopharma, Inc. is looking for a dynamic and experienced Associate Director, Clinical Operations, who will be responsible and accountable for managing the overall clinical operational activities for a study/program and may assume responsibility for additional studies/indications as they become available. The Associate Director, Clinical Operations provides strategic and operational leadership to ensure the study/program milestones are delivered on time, within budget, with high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs. The Associate Director, Clinical Operations will provide input to or establish new processes, work instructions, and SOPs to ensure consistent, effective, and efficient execution of clinical operations activities across the department.

Description

Position Overview:

Sutro Biopharma, Inc. is looking for a dynamic and experienced Associate Director, Clinical Operations, who will be responsible and accountable for managing the overall clinical operational activities for a study/program and may assume responsibility for additional studies/indications as they become available. The Associate Director, Clinical Operations provides strategic and operational leadership to ensure the study/program milestones are delivered on time, within budget, with high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs. The Associate Director, Clinical Operations will provide input to or establish new processes, work instructions, and SOPs to ensure consistent, effective, and efficient execution of clinical operations activities across the department.

Responsibilities:

• Manage multi-site clinical trials/programs involving internal and external collaborators such as CROs and various clinical vendors
• Accountable for the tactical implementation of the clinical development plan by managing the timeline, resources, and budget of clinical activities within a study/program
• Work closely with the Clinical Science team to ensure the Operational plans/activities are executed and delivered with quality and on budget from study start-up to Clinical Study Report finalization
• Participate in or accountable for the selection process of CROs and vendors for assigned studies
• Responsible for assisting with strategic planning for site/country selection, contract negotiations with vendors, patient recruitment, ensuring proper study conduct, and budget forecasting
• Responsible for the operational aspects of development and delivery of study protocols, informed consents, study plans, quality initiatives, etc. needed to conduct clinical trials
• Review site contracts and work closely with the Legal department to ensure execution of contracts to planned timelines
• Serve as the escalation point for internal/external team members and clinical sites
• Proactively identify and remediate study issues
• Work with other functions to ensure GCP compliance and inspection readiness is maintained throughout the study
• Conduct Sponsor Oversight visits to assess sites/CRAs in adherence to study plans, protocol, and GCP as needed
• Provide management with timely updates on progress and changes in scope, schedule, and resources within a study(ies), as applicable
• Line management capabilities including providing guidance, performance development, coaching and mentoring
• Strong understanding of the cost drivers and accountable for the development, management, reconciliation of overall study budget(s)
• Review/approve invoices, manage monthly accruals, and ensures timely payment processing for vendors including investigative sites (as applicable)
• Demonstrated ability to effectively collaborate with study team members to achieve the established goals within the expected time frames
• Develop, review, update, and add SOPs as required
• Develop and maintain professional relationships with opinion and thought leaders
• Representing the company at meetings with external attendees
• Lead study execution teams in collaboration with clinical development lead
  
  

Qualifications:

• Highly motivated and enjoys working in a fast-paced environment
• Strong organizational skills and the ability to prioritize and multi-task
• Ability to work independently and under pressure with changing priorities
• Possess strategic thinking and proactive identification of issues
• Excellent judgment and problem-solving skills
• Exceptional verbal and written communication skills
• Flexible as it relates to responsibilities/assignments since Sutro is a small company and job scope/role will inevitably evolve as the company and department matures
• Willingness to travel as necessary, consistent with project needs
• Computer proficiency (Outlook, MS Word, Excel, and PowerPoint)
• 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
  
  

Education/Experience:

• Bachelors/Master’s (or equivalent) in a health care or other scientifically related field with 15+ 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
• 10+ years of monitoring experience, ideally with a mix of CRO and biopharmaceutical experience
• Strong background in drug development; 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
• Strong knowledge of FDA/EMA regulatory requirements and ICH/GCP guidelines
• Office based position with some travel (domestic and international), up to 25%.
  
  

Sound exciting? Apply today and join our team!

Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment.

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.

To recruiting firms: Sutro Biopharma does not accept agency resumes and solicitations from third-party agencies. Please do not forward resumes to our hiring managers or employees. Sutro Biopharma is not responsible for any fees related to unsolicited resumes.

The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $186,000 - $200,000 (not including bonus, equity, and benefits). The base salary offered will vary depending on the market, job-related knowledge, skills and capabilities, and experience.

About Sutro Biopharma

Sutro Biopharma, Inc., is relentlessly focused on the discovery and development of precisely designed cancer therapeutics to transform what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF, provides the opportunity for broader patient benefit and an improved patient experience. Sutro is advancing a robust early-stage pipeline of novel exatecan and dual-payload antibody drug conjugates (ADCs), coupled with high-value collaborations and industry partnerships, which validate its continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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