Senior Manager, Monitoring Oversight

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. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly 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.  

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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