AD Clinical Operations- Ophthalmology
4D Molecular Therapeutics
At 4D Molecular Therapeutics, Inc. (“4DMT”), we boldly innovate to unlock the full potential of genetic medicines for countless patients. We are committed to breaking boundaries and daring to cure as we develop new and foundational products and product components through our growing technology platforms.
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, Clinical Operations will work under Sr. Director of Clinical operations and will be responsible for implementation, execution, and oversight of Phase 1-3 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:
- Manage clinical trial(s) in a TA in compliance with corporate objectives, timelines and budget
- 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, line-management 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 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 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 program/trials 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 leads/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 phases
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
Requirements:
Education: BS/BA in Life Science or related discipline; advance degree (MS, MPH, MHS, Ph.D., MBA) preferred.
Experience:
- 8 years+ of applicable industry experience in drug development across both early (Phase 1 or 2) and late-stage (Phase 3) clinical development, with a minimum of 2+ years managerial experience.
- Ophthalmology experience strongly preferred.
- Strong Vendor Mgmt Experience
- Budget Review and Oversight Experience
- Strong Clinical Trial Start Up Experience
Licenses or Certifications: Clinical Research certification preferred, but not required
The National base salary compensation range is $164,000 - $190,000.
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.