Associate Director, Pharmacology/Toxicology Study Monitor (Hybrid)

At 4D Molecular Therapeutics, Inc. (“4DMT”), we boldly innovate to unlock the full potential of genetic medicines for countless patients. We are committed to breaking boundaries and daring to cure as we develop new and foundational products and product components through our growing technology platforms.

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.  

We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.

To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.

In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.

Company Differentiators: 

•    Fully integrated clinical-phase company with internal manufacturing
•    Demonstrated ability to move rapidly from idea to IND
•    Five candidate products in the clinic and two declared pre-clinical programs
•    Robust technology and IP foundation, including our TVE and manufacturing platforms
•    Initial product safety and efficacy data substantiates the value of our platforms
•    Opportunities to expand to other indications and modalities within genetic medicine

Purpose: 

The primary purpose of the Associate Director, Pharmacology/Toxicology Study Monitor is to support members of our research team in the initiation, execution, and management of nonclinical pharmacology and toxicology studies with contract research organizations (CROs).  This position will work primarily with R&D teams in an office setting, with hybrid and/or remote opportunities.   

*This is a Hybrid role requiring 1-3 days a week in office work as needed. Bay Area based candidates preferred.*
  

Essential Job Responsibilities:  

• We seek an experienced, innovative, and team-oriented pharm/tox Study Monitor that can take a significant role in the following activities:  
• Monitor in vivo Pharmacology/Toxicology studies in rodents and NHPs (nonGLP and GLP).    
• Perform regular site visits at CROs for in vivo studies to ensure compliance to study protocols and procedures.   
• Management of preclinical study operations, including sample shipment logistics and tracking of timelines and deliverables.  
• Maintain master study schedule for multiple ongoing Pharm/Tox studies across research and development.  
• Assist in review of study documentation and results, including QA/QC of raw data.  
• Provide administrative support for nonclinical studies, including integration of reported data into internal data management system.  
• Domestic travel to monitor studies at contract research organizations is required   

Qualifications  Required:  

• 4+ years' relevant experience with PhD in a scientific discipline (Pharmacology, Toxicology, Immunology, etc) with previous relevant experience in the management and operations of CRO-based preclinical studies.  
• 12+ years’ relevant experience with BS/BA; 8+ years’ relevant experience with MS/MA; 
• Critical review of study-related documents (protocols, amendments, and reports) for completeness, accuracy, and consistency.    
• A comprehensive understanding of the conduct of nonclinical pharmacology and toxicology studies in nonhuman primates with a high attention to detail are important attributes for this role.  
• Understanding and knowledge of key scientific software programs (including Microsoft Office, and Prism).  
• Strong organizational skills, analytical skills, and problem-solving skills.  
• Willingness to learn and grow, with enthusiasm to be part of the development of a cutting-edge gene therapy platform in multiple therapeutic areas.  

  

Preferred:  

• Knowledge and hands-on experience in planning, executing, analysis and reporting of in vivo pharmacology and/or toxicology studies is required. Experience as a Study Director would be an advantage.  
• Experience with multiple species, including NHPs is preferred.  Experience with the development of gene therapies is a plus.  
• Previous experience in the identification and management of external CROs.  
• Knowledge of global regulatory guidelines (ICH/GLP/OECD) and monitoring of GLP-compliant toxicology studies is a plus.  
• Adept at managing and executing multiple projects in a fast-paced and innovative research setting.  

Base salary compensation range:

Bay Area Range: $166,000/yr - $200,000/yr

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

 

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities