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Senior Director, Clinical Science

Employer
4D Molecular Therapeutics
Location
Emeryville, California
Start date
Jun 14, 2024

View more

Discipline
Clinical, Clinical Research
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details

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: 

Reporting to the SVP TAH Ophthalmology, the Senior Clinical Scientist will play an integral role in facilitating successful advancement of ophthalmology gene therapy programs. The position supports clinical and scientific aspects of all assigned clinical programs. 

RESPONSIBILITIES:  

  • Partner with cross-functional program team members and key R&D stakeholders to support the development of innovative study designs, clinical trial protocols and amendments, investigator brochures, and other documents required to conduct clinical trials 
  • Provide clinical support for clinical study conduct, including operational feasibility, data management, communication plans, safety and medical monitoring, preparation of meeting materials and study updates. 
  • Provide scientific support and cleaning/querying of key safety and efficacy data for ongoing clinical trials throughout conduct 
  • Prepare and communicate clear overviews of trial results. 
  • Identify issues related to study conduct and/or subject safety. Provide preliminary assessments and recommendations and collaborate with the clinical team to develop solutions ensure resolution. 
  • Interact with internal and external stakeholders (study sites, vendors, KOLs, etc.) in support of program-level strategy as well as clinical trial objectives 
  • Act as recognized clinical expert for assigned programs. 
  • Contribute to the preparation of medical and scientific data for publications, presentations, and study milestones (including meetings for Executive Team, Board of Directors, Advisory Boards and Data and Safety Monitoring Committees [DSMC]) 
  • Together with Medical Director of Ophthalmology, serve as a point of contact for the clinical operations personnel, clinical trial sites and CROs for clinical science questions 
  • Maintains knowledge of ICH-GCP and FDA IND, and external regulations and procedures. 
  • Contribute to authoring clinical documents such as protocol synopsis, clinical study reports, IBs, ICFs, training documents, and other clinical documents. 
  • Author pertinent clinical sections of regulatory filings, including preparation of routine correspondence and sections of INDs, BLAs, NDAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications, and other regulatory submissions 
  • 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: 

  • An advanced degree, e.g. MA or MS in a biological/health science field is required, with OD, PhD, or PharmD preferred 

Experience: 

  • 15+ years Clinical science experience with 5+ years of drug development with experience in ophthalmology drug development, preferably in retinal disease 
  • Advanced experience in clinical trial design, implementation, regulatory document preparation and statistics. 
  • Phase 3 experience, retinal gene therapy experience, NDA/BLA/MAA submission experience  

Skills: 

  • Ability to interpret, analyze, and present clinical data 
  • Thorough understanding of the drug development process 
  • Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization). 
  • Demonstrated ability to communicate and write clearly, concisely, and effectively. 
  • Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy. 
  • Understanding of trial design and statistics 
  • Well-organized: ability to prioritize tasks with a successful track record of managing multiple projects in a fast-paced and deadline-driven environment. 
  • Good leadership and management skills to manage internal and external collaborations and work well within cross-disciplinary teams. 
  • Ability to travel, approximately 10%. 

Physical Requirements:  

  • Primarily computer use and long periods of sitting, standing 
  • To maintain a healthy and safe workplace for all during the COVID-19 this role is expected to work remotely and return on-site in 2022 on a hybrid schedule 
  • Adhere to 4DMT Covid protocols and policy. This includes all employees and contractors must share proof of current vaccination status to work onsite.  

Base Salary Range:

National Range: $252,000/yr - $314,000/yr 

Bay Area Range: $271,000/yr - $328,000/yr

 

Please note that compensation varies depending on experience, location, etc

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

Company

4DMT is a gene therapy company with a transformative discovery platform --Therapeutic Vector Evolution --that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.


At 4DMT we are creating and developing optimized “biopharmaceutical grade” AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases.


While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors. The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration.


At 4DMT we use our robust discovery platform, termed “Therapeutic Vector Evolution,” to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo.


4D Purpose Statement:  Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients


GUIDING PRINCIPLES

 

  • Dare to Cure - Patients are waiting. Create big dreams for patients and take calculated risks to achieve them
  • Break Boundaries - Question the status quo and innovate beyond conventional approaches
  • Beyond Yourself - It's about patients, their families, our team, our families. We strengthen each other.
  • Prepare and Execute Relentlessly - Start with the end in mind, over-prepare and make contingency plans to your contingency plans


We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. We seek the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers generous benefits and provides challenging opportunities for career development. 
 

Company info
Website
Phone
510-505-2680
Location
5858 Horton St. Suite 455
Emeryville
California
94608
United States

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