Director, Safety Assessment
Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in the oncology and auto-immune disease space. Our portfolio includes antibody-drug conjugates, bispecific antibodies, cytokine derivatives and other novel immuno-stimulatory approaches.
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
- 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
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.
Sutro Biopharma is committed to the diversity of our team and we are committed to Equal Employment Opportunity without regard for race, ethnicity, gender, protected veteran status, disability, sexual orientation, gender identity or religion.
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.