Description:
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 Director, Clinical Operations supports the VP in leading and managing the Clinical Operations group to design and execute clinical trials per corporate objectives, corporate standard operating procedures (SOPs), and Good Clinical Practice (GCP).
Essential Duties & Responsibilities:
- Partner with VP, Clinical Operations & Data Management or Sr. Director of Clinical Operations to develop and manage program operational strategies and plans for all products in compliance with corporate objectives and timelines
- Develop resourcing plans and clinical trial timelines across assigned clinical programs including hiring, training, mentoring, and retaining staff
- Participate as Clinical Operations subject matter expert (SME) on annual budgets to support clinical trial activities and required infrastructure
- Participate as an SME for clinical operations related due diligence activities
- Independently oversee day-to-day activities of the Clinical Trial Operations for assigned programs
- Collaborate with Finance on annual budget planning (external spend) as well as quarterly budget reviews and re-forecasts; overseeing clinical vendor outsourcing strategy within their assigned program(s);
- 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
- Directly manage and actively partner with Clinical Trial and Program Leads to ensure that clinical trial protocols are executed to meet corporate objectives and in compliance with corporate SOPs and GCP
- Sit on product cross-functional core teams as Clinical Operations SME, as required
- Develop and present program or departmental initiatives and/or activities to Clinical Development leadership and/or Executive Team
- Support development of and identify Clinical SOPs and work instructions to ensure consistency across 4DMT trials and SETs
- Ensure program adherence to SOPs, work instructions, and other governance documents, including timely training
- Partner closely with Quality to ensure that their assigned programs 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) for assigned program(s)
- Partner with other group and/or functional leaders across 4DMT to identify and to implement best practices to ensure that 4DMT meets corporate objectives and adapts to changing business needs
- Actively support and foster cross-functional communication.
QUALIFICATIONS:
Education:
- BS/BA in Life Science or related discipline; advanced degree (MS, MPH, MHS, Ph.D., MBA) preferred.
Experience:
- A minimum of 10 years of applicable industry experience in drug development (Clinical Operations) late-stage (Phase 3), and 5+ years direct line management experience.
Core Competencies, Knowledge and Skill Requirements:
- Proven ability to recruit, retain, organize, and motivate clinical operations personnel
- Ability to communicate to leadership team on Clinical Operations updates and priorities as well as to advocate for required budget and resources
- Ability to manage and oversee large scale 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
BASE SALARY COMPENSATION RANGE:
Bay Area-based candidates: $230,000/yr. - $253,000/yr.
National range: $202,000/yr. - $235,000/yr.
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