Senior Director, Clinical Science

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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.  

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: $252,000/yr - $328,000/yr

Base salary compensation range: $271,000 - $380,000

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.

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