Senior Director, Pharmacometrics (South San Francisco, CA)

Sutro Biopharma, Inc. is looking for visionary, energetic and talented PK Scientist reporting into the VP Preclinical Development. The individual designs, executes and reports PK-PD /TK studies in support of early discovery to first in human trials. S/he brings experience with working on complex molecules such polymer conjugated proteins, antibody-drug conjugates, and small molecules. Fosters strong collaborations with Pharmacology, Medicinal and Protein Chemistry, Toxicology, Clinical Development and regulatory. Hires, mentors, and manages subject matter experts in ADME, modeling & simulation and vivarium staff.

Responsibilities:

• Recruits for and builds a creative and innovative DMPK function
• Identifies, recommends, and procures PK relevant software platforms
• Develops the screening paradigms to advance molecules from early concept through lead optimization to IND enabling studies
• Guides and advises staff members to be effective functional representatives on project teams
• Identifies key questions and proposes stage appropriate experiments to address the issues
• Implements hypothesis driven modeling approaches to assist lead optimization
• Integrates in-vitro, in-vivo PK-PD and ADME data to identify optimal properties
• Establishes and manages CRO relationships as the principal investigator on studies
• Participates in protocol generation for PK-PD and toxicology studies and advises on dose levels, dosing schedule, parameter selection, and BA requirements
• Provides FIH dose projections
• Authors reports, regulatory documents (pIND package, briefing packages and relevant IND/BLA/NDA modules)
• Supports business development and patent applications with documentation and data and participates in due diligences

Qualifications:

• D. in the field of PK/ADME with a minimum of 15 years of relevant industry experience (biologics & small molecules)
• Track record in lead optimization, regulatory submissions and publications is a must
• Being resourceful is a requirement
• Familiar with PK-PD modeling, the concepts of machine learning, and databases
• Proficient with PK software platforms including but not limited to WinNonlin, Monolix, SimCyp, and GastroPlus
• Demonstrated leadership, mentorship, and people management
• Working experience with ADC, PEGylated molecules, and in immuno-oncology is a plus
• Familiarity with analytical methods such as LC-MS/MS and ELISA
• Experience with TMDD and ADA
• Experience with translation of nonclinical PK to humans
• Familiar with relevant FDA and ICH guidance’s

Sound exciting? Apply today and join our team!

Please submit resume for Req. #2207 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.