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Associate Director, Clinical Operations
2 months ago
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
Position Summary:
The Associate Director, of Clinical Operations will be responsible for implementation, execution and oversight of all clinical trials within a clinical program, in coordination with cross-functional project teams in order to ensure that assigned clinical trials are executed on time, within budget, and in compliance with GCP and other applicable guidelines and regulations.
Essential Duties & Responsibilities:
Partner with Sr. Director of Clinical Operations to develop and manage clinical programs in compliance with corporate objectives and timelines Provide operational leadership to the direction, planning, execution and interpretation of clinical trials and data collection by effectively developing and monitoring clinical trial/program timelines, budgets, risks and mitigation plans Provides guidance and mentoring to Clinical Trial Managers (CTMs) and junior level team members in study document development, vendor and study management, study implementation, issue resolution, timelines, budgeting and resourcing Independently oversee day-to-day activities of the Clinical Trial Operations and Clinical Data Management groups Collaborate with Finance/Business Operations on annual budget planning (external spend) as well as quarterly budget reviews and re-forecasts; designing, implementing, and overseeing clinical vendor outsourcing strategy; actively participating in the selection of vendors to support 4DMT clinical trials as well as active governance of them; participating and/or leading vendor governance committees Ensure that each clinical trial is always inspection ready Ensure that each clinical trial is being actively managed by a cross-functional Study Execution Team (SET) May sit on product cross-functional core teams as Clinical Operations SME Partner closely with Quality to ensure that the programs and 4DMT always remain inspection ready Collaborate with Regulatory Affairs and Clinical Sciences on the creation of regulatory submissions and compliance to regulatory requirements (eg, Clincialtrials.gov) Addresses escalated study issues in collaboration with CTMs and senior management as appropriate inclusive of risk mitigation plans Coordinates the development and maintenance of clinical SOPs as pertains to the program and provides review/ input into cross-functional SOPs and other documents Supports development and review of protocols/ amendments, study documents and plans, and operational execution Actively participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provides ongoing surveillance of progress and ensures that contingency plans are triggered as and where appropriate Contributes to the development of the Clinical Operations department processes and procedures and will manage clinical resources to ensure effective implementation of trials.
Core Competencies, Knowledge and Skill Requirements:
Proven ability to recruit, retain, organize, and motivate clinical operations personnel Ability to communicate to Clinical Operations and Development Leadership team updates and priorities as well as to advocate for required budget and resources Ability to manage and oversee programs that have corporate-wide impact Ability to develop and manage functional and clinical trial-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 trials and business performance Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials Ability to be flexible and adaptable to changing business needs Relevant experience in clinical trial execution across all phasesCommunication & 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 audiencesRequirements:
BS/BA in Life Science or related discipline; advanced degree (MS, MPH, MHS, Ph.D., MBA) preferred. Require 1+ years of ophthalmology trial experience as well as late-phase trial experience. A minimum of 8 years of applicable industry experience in clinical development with a minimum of 3 years managerial experience. Clinical Research certification is preferred, but not required.Base Salary Compensation Range:
$186,000/yr. - $208,000/yr.
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
