Senior Manager, Monitoring Oversight

4 weeks ago

Emeryville, California, 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:

The Sr Manager Clinical Oversight Monitoring (COM Sr Mgr.) will be responsible for overseeing clinical monitoring activities performed by CRO and contract monitors, ensuring compliance with clinical monitoring plans, protocols, ICH/GCP guidelines, and related documents. They will work cross-functionally with stakeholders to maintain inspection readiness and monitoring quality, develop oversight processes, and SOPs. The role involves progressing the 4DMT monitoring oversight program, scaling operations across global programs, and managing organizational structure to meet regulatory and 4DMT requirements.

RESPONSIBILITIES:

Manage the 4DMT COM function globally as required

Collaborate with management to develop a monitoring oversight function

Further develop, execute, and manage the Clinical Oversight Monitoring Plan and ensure compliance with industry standards

Develop, utilize, and oversee metrics tools to assure the oversight activities are conducted in accordance with applicable regulations, SOPs and trial and Travere objectives

Interacts closely with study team throughout the lifecycle of the study.

Conduct QC review of monitoring visit reports, monitor visit scheduling, report completion metrics, protocol deviations, issues, and action items to identify COM, monitor, site, and study-level issues.

Oversee the internal process of monitoring visit report reviews by COM team and finalization metrics to assure compliance with internal and trial-specific plans

Proactively identify trends, issues, and risks related to monitoring and monitoring processes/plans

Work cross-functionally to create shared solutions

Ensure cross-functional understanding of applicable regulations and requirements

Develop metrics as required

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 or master's degree in related Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered.

Experience:
It is preferred that the candidate have 8+ years of experience in a similar role.

Clinical Monitoring experience required, with a preference for Ophthalmology monitoring experience (retina experience is a definite plus)

Understanding of clinical trials and advanced knowledge of ICH-GCP, Clinical trials regulations, and applicable global and regional/country requirements.

Mastery of global regulatory requirements and guidelines

Inspection experience (MHRA/EMA experience a plus)

Previous management experience of direct reports

Excellent stakeholder management skills coupled with influencing and negotiation skills

Understanding of resource management and organizational capacity

Demonstrated ability to think strategically across the organization.

Skills:
The ideal candidate will embody 4DMTs core values: Dare to Cure - Break Boundaries - Beyond Yourself - Prepare & Executive Relentlessly

Strong interpersonal communication (written and verbal), and organizational skills

Able to motivate a team to work effectively under a fast-paced and changing environment

Strong work ethic and demonstrated ability to deliver assignments on time

Proficient with office automation tools, such as Microsoft Office toolkit.

Strong professional experience in a similar role within the pharmaceutical industry.

Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.

Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.

Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.

Ability to travel as required.

Base salary compensation range: $114K - $181K
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

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