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Associate Clinical Outsourcing

2 months ago

Emeryville, United States 4D Molecular Therapeutics Full time

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

 

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

GENERAL SUMMARY:  

We are looking for a highly motivated and experienced Clinical Outsourcing & Business Operations Associate to play a key role in supporting the Company’s clinical trial activities. This position requires a strong analytical mind, excellent communication and organizational skills, with a keen eye for detail. You will thrive in a dynamic, team-oriented environment and be willing to go the extra mile to achieve departmental and company goals. 

RESPONSIBILITIES:   

Clinical Outsourcing: 

Partner with cross-functional teams to identify, select, and qualify clinical vendors (CROs, reading centers, labs, patient support services, etc.).  Lead contract negotiations, ensuring favorable financial terms for clinical contracts and change orders.  Facilitate effective vendor governance meetings and manage vendor relationships.  Develop, implement, and document standard operating procedures (SOPs) for all outsourcing activities.  Continuously improve processes and tools related to clinical trial outsourcing.  Track and monitor key vendor performance indicators (KPIs). 

 Business Operations: 

Analyze site budgets, invoices, and contracts.  Support the annual budget forecasting and re-forecasting process.  Conduct ad-hoc financial analyses as needed by Clinical Operations.  Collaborate with finance teams to ensure accurate and timely accrual of clinical trial expenses. 

Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time  

QUALIFICATIONS:  

Education:  

Bachelor’s degree required, MBA preferred. 

Experience: 

 2-3 years of experience with CRO or biotech in similar roles preferred. 

 Skills:  

Analytical thinking and problem-solving skills  Excellent communication (written and verbal)  Strong organizational skills and attention to detail  Team player with the ability to collaborate effectively across departments  Proactive and adaptable with the ability to manage change  Ability to thrive in a fast-paced environment  Quick learner  Proficiency in Microsoft Excel and PowerPoint 

Base salary compensation range:

$86,000/yr - $112,000/yr 

Please note that compensation varies on a variety of factors including location, skillset, etc

  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