Director Clinical Science South San Francisco CA

Profile

Sutro is looking for a Director level candidate to join our Clinical team. The Clinical Scientist is a key cross-functional team member contributing to the design and execution of Sutro’s clinical trials. They are responsible for analyzing and interpreting study data and translating clinical data across and within programs and studies. This team member will provide expertise to internal and external teams to ensure that Clinical Development scientific and medical strategies are met. This role requires an in-depth understanding of the clinical development process (from Phase 1 through registration, post-registration desirable) and all functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences, and clinical operations.  

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Open, effective, and proactive communication of the clinical development activities is critical for success in this role. Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have strong work ethics and be able to work independently and productively. Must be willing to travel up to 25%.

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Responsibilities:

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• Contribute to the design, implementation and review of clinical protocols and study reports for scientific and operational accuracy
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• Contribute to the design, start-up, execution, analysis, and communication of the clinical studies for a product candidate
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• In collaboration with Clinical Operation and Statistics, responsible for timely delivery of high-quality clinical study data analysis; present clinical study results to the cross functional team and to the company Senior Management Team and external stakeholders
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• Work very closely with study investigators to ensure timely and high-quality execution of clinical studies
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• Work with KOLs to review clinical data and develop clinical development strategy
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• Collaborate with Clinical Operations to expedite execution of clinical trials
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• Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms to apply knowledge to support a robust clinical development strategy
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• Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators, CRO and field team on developing robust study protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Performs site monitoring with field team, as needed
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• Responsible for writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB
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• submissions/approvals, site activations, monitoring plan and tools, CRF’s, DMP, edit checks, safety plan, Safety Evaluation Team and DMC charter, close-out plans, and CSRs
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• Assist with the development of study presentations, handouts, and coordination of Investigator Meetings
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• Analyze data and assist in writing for publications and scientific presentations
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Qualifications:

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• M.D./Pharm.D./Ph.D. in biology/bioengineering/biochemistry field with prior experience managing oncology trials; A Master’s degree and nursing degree may be considered with supporting industry experience
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• The candidate should have a minimum of 5 years of clinical research experience in domestic and international clinical trials, oncology trial experience is highly preferred
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• Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations
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• Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward
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• Excellent written and oral communication and presentation skills
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• The ability to manage multiple priorities, while maintaining attention to detail is critical
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• Experience operating effectively within a matrixed environment, specifically in a healthcare biotech/pharmaceutical start-up setting
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• Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities
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• Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels
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• Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms)
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Sound exciting? Apply today and join our team!

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Please submit resume for Req. #2216 . Please visit our website at ****rel=no-follow>****for more information.

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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.

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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.

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Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.

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Please be advised, inquiries or resumes from recruiters will not be accepted.

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Company Overview

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**MEMBERS ONLY**SIGN UP NOW***.., 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.

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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.

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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.

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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.

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