Vice President

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 VP of Clinical Operations, is accountable for operational oversight of all clinical trial conduct, including trial planning, execution and oversight, budget and resource management, management of contract research organizations (CROs) and other GCP vendors for our ophthalmology pipeline. Key responsibilities will include coordinating and leading the Clinical Operations, ophthalmology team to support design and execution of clinical trials per corporate objectives, standard operating procedures, and Good Clinical Practice (GCP). This role will be a member of the Clinical Development Leadership Team and will work closely with CMO/Ophthalmology Therapeutic Area Head and functions including Clinical Sciences, Regulatory Affairs, Quality, Clinical Compliance, Data Sciences, Tech Ops, and Translational Biomarker Operations to ensure seamless and timely execution of clinical trials from Ph 1-3 that enable inspection ready data.

Essential Duties & Responsibilities:
•  Provides strategic operational guidance to ensure that all clinical trials are properly defined, planned and executed across all clinical stage ophthalmology programs; by developing resourcing plans, clinical trial timelines, and annual budgets to support trial plans/protocols and corporate goals.
•  Partners closely with SVP Development Operations to develop and improve departmental infra-structure including SOPs, work practices, training, and workshops and ensures trial activities are inspection ready at all times and ensure that 4DMT is a sponsor of choice
•  Act as a key contributor to annual budgets and forecasts for projects and functional areas under responsibility
•  Collaborate closely with Finance to support appropriate quarterly and annual financial reporting related to clinical trial activities
•  Oversee day-to-day activities of the global Ophthalmology Francise Clinical Operations departments
•  Ensure clinical trial timelines are developed, tracked and shared with cross-functional project teams
•  Ensure executive dashboards and updates are concise/accurate and on time
•  Ensure important trial operational issues are escalated to executive management
•  Develop and lead the outsourcing vision for the ophthalmology clinical operations function. Strategically drive the evaluation, selection, and management of external service providers across multiple programs and studies including tracking Key Performance Indicators and participation in CRO/Vendor Governance meetings alongside the Clinical Outsourcing and Business Operations team
•  Lead and manage key external partnerships and alliances related to clinical trial execution
•  Develop and present functional organizational goals, budget and/or activities to executive team
•  Define functional staff resourcing needs, including hiring, training, mentoring and retaining staff to ensure high performance teams
•  Define and develop implementation plans for internal systems to ensure compliance, efficiency and high performance
•  Develop and ensure departmental adherence to SOPs, work instructions, and other governance documents
•  Partner with Quality Assurance to develop the strategic plan for clinical regulatory audits and inspections for clinical vendors, clinical sites and internal processes
•  Partner with Clinical Compliance to ensure all clinical systems, training programs and appropriate processes and procedures are implemented to ensure GCP compliance and inspection readiness
•  Considered SME for SOPs, initiatives, and advancement of clinical operations and data management as an organization
•  Partner with other leaders across clinical development to identify and to implement best practices to ensure that all current, planned and future clinical programs meet corporate objectives and adapts to changing business needs and growth
•  Serve as Clinical Operations point of contact for ophthalmology portfolio planning and business development opportunities Core Competencies, Knowledge and Skill Requirements:
•  This leadership position requires a self-directed, dynamic, inspirational leader with a passion for advancing treatment options and outcomes
•  Proven ability to recruit, retain, organize, and motivate clinical operations personnel
•  Proven leadership of a maintaining and building a best in class the Clinical Operations and Data Management function
•  Ability to communicate to executive leadership team on Clinical Operations and Data Management updates and priorities as well as to advocate for required budget and resources
•  Ability to manage and oversee large scale, fast moving programs that have corporate-wide impact
•  Ability to develop and manage functional and study-specific budgets
•  Must be self-motivating; prioritize and manage a large volume of work; show attention to detail
•  Strong interpersonal skills are essential as this individual will partner with various team members and functional groups for clinical studies and business performance
•  Thorough knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials
•  Ability to be flexible and adaptable to changing business needs
•  Relevant experience in clinical study execution Communication & Interpersonal Skills:
•  Excellent communication and interpersonal skills
•  Must be able to write clearly and summarize information effectively
•  Must be able to present complex information to various audiences Significant Contacts:
•  Internal employees, including executive team members
•  External clinical trial investigators and site team members
•  External service providers
•  External patient advocacy groups Requirements:

Education: Bachelor's degree (or equivalent), preferably in scientific discipline or a health-related field

Experience:
•  18+ years of clinical operations experience in the pharmaceutical or biotechnology industry, including experience with global clinical programs across both early and late-stage clinical development
•  8+ years of direct line management experience . click apply for full job details