Director, Safety Assessment (South San Francisco, CA)

The qualified candidate is a highly motivated, interactive, and creative individual with a strong background in oncology drug development and proven ability to contribute to evaluation of pharmacologic/toxicologic mechanism(s) of drug-induced responses. The ideal candidate has demonstrated ability to work across a highly matrixed environment to advance translational efforts across complex biologic pathways and multiple programs. You will be an integral driver for translating discovery research into the clinic, including exploratory, pilot, and pivotal toxicology studies and develop safety assessment strategies for advancement to the clinic.

Duties and Responsibilities:

• Represent the toxicology function on project teams to define and implement nonclinical safety evaluation of novel candidate
• Lead the design, oversight, interpretation, and reporting of nonclinical toxicology programs to support the selection and timely development of Sutro’s therapeutic
• Develop and implement target de-risking and screening strategies in discovery teams to support lead optimization efforts
• Provide internal expertise to understand the mechanisms of toxicity observed non-clinically in order to drive mitigation and/or back-up strategies to minimize potential harm topatients
• Author and review nonclinical safety pharmacology, biodistribution and toxicology sections of regulatory documents for submissions in the US and ex-US (eg. IND, CTA, BLA, IBsetc)
• Build collaborative networks both internal and external to the company to ensure rapid communication and cross-functional evaluation
• Represent Sutro Biopharma with collaborators and the external scientific environment

Qualifications:

• PhD/DVM with 8+ years of relevant technical experience in Toxicology, Pharmacology, and or related fields or MS with 10+ years of equivalent experience. D.A.B.T preferred
• Drug discovery/development experience with a proven track record of conducting drug safety assessment studies for oncology products
• Hands-on experience in designing and executing on in vivo toxicology studies for small molecules and biologics, experience with antibody drug conjugates and immunomodulatory molecules required
• Demonstrated ability to manage multiple scientific projects and make sound scientific interpretations and risk assessments
• Working knowledge of regulatory guidance’s (eg. FDA, EMA, ICH etc) as it pertains to the strategic planning and conduct of non-clinical safety packages to support clinical development programs
• Strong scientific writing skills and experience in preparation, strategy, writing and editing of regulatory documents (pre-IND packages, INDs, CTAs, BLA,etc)
• Excellent organizational and interpersonal skills, ability to effectively communicate and collaborate across internal multidisciplinary teams
• Proven ability to work independently and be self-motivated with agility to work in a fast-paced matrix environment

Please submit resume for Req. #2063 to . Please visit our website at www.sutrobio.com for more information.

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.

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

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

Company Overview

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.