Director, Safety Assessment (South San Francisco, CA)
The qualified candidate is a self-starter, highly motivated, interactive, and creative individual with a strong background in oncology/immune-oncology drug development of biologics and small molecules. The candidate has a track record of mitigating toxicity/safety issues during development. The candidate is a subject matter expert on 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.
- Develop the safety / toxicology development strategy for SUTRO assets.
- Identify the potential safety / toxicology risks associated with novel therapeutic concepts and recommend mitigation strategies.
- Represent the toxicology function on project teams to define and implement nonclinical safety evaluation of early (discovery & clinical candidate) and late stage (clinical asset) development candidates.
- Identify and select appropriate CRO’s for non-GLP / GLP safety and toxicology studies. Develop study protocols in partnership with stake holders (e.g. including but not limited to bioanalytical department, DMPK, protein chemistry, and pharmacology).
- Manage safety and toxicology studies at CRO’s. Review and interpret safety / toxicology results and provide recommendation.
- Provide internal expertise to understand the mechanisms of toxicity observed non-clinically to drive mitigation and/or back-up strategies to minimize potential harm to patients.
- Author and review nonclinical safety pharmacology and toxicology sections of regulatory documents for submissions in the US and ex-US (eg. IND, CTA, BLA, IBs etc).
- Liaise with DMPK to project efficacious and safe dose levels in clinic including starting dose for clinical trials. 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.
- Hands-on discovery/development experience with a proven track record of conducting drug safety assessment studies for oncology / immune-oncology (biologics and/or small molecules (biologics and/or small molecules such as antibody drug conjugates) is a must.
- Demonstrated ability to manage CRO’s, multiple scientific projects, and make sound scientific interpretations and risk assessments.
- Proficient in regulatory requirements (eg. FDA, EMA, ICH etc) to support non-clinical and 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 matrixed environment.
- Experience with PK/TK calculations is a plus.
Sound exciting? Apply today and join our team!
Please submit resume for Req. #23-150-001N to email@example.com. Please visit our website at www.sutrobio.comfor more information.
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.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
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 $225,000 – $255,000 (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.